Single-institution Prospective Study Research Articles

Abstract PO1-20-01: A Prospective Single-Arm Pilot Interventional Trial to Assess Individual Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery

Abstract Background: The number of individuals who identify as transgender and/or gender-diverse (TGD) is steadily increasing and the number of individuals seeking chest masculinization surgery, commonly called “top-surgery,” is also increasing. In persons assigned female at birth, top surgery removes most breast tissue to allow the chest to appear masculine. However, top surgery is not equivalent to oncologic risk-reducing mastectomies (RRM), which aim to remove all breast tissue to reduce future breast cancer (BC) risk. While top surgery has significant psychological and health benefits, its impact on future BC risk is unclear, especially for those individuals who are at high-risk for future BC development (defined as ≥17% by international consensus guidelines) and/or have a pathogenic germline mutation for BC. The aims of this study are to 1) determine the percentage of TGD persons assigned female at birth who are considering undergoing top surgery and are at elevated BC risk using validated risk models, 2) determine the percentage of TGD persons at elevated BC risk who choose to undergo RRM as part of top surgery, and 3) assess and compare self-perceived BC risk compared to calculated risk. Methods: A single-institution prospective single-arm pilot study is currently underway from March 2023 through January 2024. Individuals assigned female at birth, who are age ≥18 years, and considering undergoing top surgery, but have not yet undergone top surgery, are eligible to enroll (goal accrual N=35). Participants are being actively recruited form our institution’s Comprehensive LGBTQIA+ Inclusion Health Clinic and Plastic Surgery Clinic. Consented participants undergo a personalized BC risk assessment the validated IBIS and Gail (for those ≥35 years old) BC risk models. Those with an average lifetime BC risk (< 17%) are recommended to continue top surgery as planned/no intervention, participants with a moderate lifetime BC risk (17-30%) are counseled they may consider RRM as part of their top surgery operation given that sparse data exists in this space, while those with a high lifetime BC risk ( >30% or pathogenic germline variant) are counseled on the potential benefits of RRM. Participants with a family history suggestive of a hereditary cancer syndrome meet with a certified Genetics counselor for consideration of genetic testing, per NCCN guidelines. Results: We anticipate reporting 1) general demographic description of the cohort, 2) the percentage who have an elevated lifetime BC risk and/or a pathogenic genetic mutation, 3) the percentage of those with an elevated risk who choose to undergo RRM as part of top surgery, and 4) report the differences between self-perceived vs calculated lifetime BC risk. Conclusion: Our findings will inform TGD persons and surgeons on the utility of a personalized BC risk assessment prior to top surgery to assist in surgical decision-making, report the accuracy of self-perceived BC risk in TGD persons, and potentially change the standard pre-operative evaluation for TGD persons considering top surgery to include a formal BC risk assessment to ensure high-risk individuals have the option to undergo RRM to appropriately reduce their future BC risk. Citation Format: Chandler Cortina, Anna Purdy, Samantha Stachowiak, Kristen Klement, Sarah Sasor, Kate Krucoff, Andrew Petroll, Kevin Robertson, Annie Lakatos, Erin Doren. A Prospective Single-Arm Pilot Interventional Trial to Assess Individual Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-20-01.

Streamlining the Management of Children With Simple Hand Injuries

Background: Hand injuries are common in children. Most simple pediatric hand fractures do not require surgery and can be treated with protective immobilization, yielding good outcomes. A recent institutional audit revealed significant practice variation in managing these children with many being overtreated with unnecessary follow-up visits. The objective of this study was to implement and assess a streamlined care pathway to manage “simple” pediatric hand injuries and minimize healthcare utilization. Methods: A single institution prospective study of the streamlined care pathway was conducted. Simple hand injuries included volar plate injuries, phalangeal Salter-Harris type 2 fractures, metacarpal neck fractures, unicortical and buckle fractures, proximal interphalangeal dislocations, and thumb ligamentous injuries. Patients were treated with either thermoplastic splinting or buddy taping. Standardized verbal and written instruction were provided. No routine follow-up was arranged. Participants were contacted by telephone 6 weeks post-injury to identify any concerns or need for follow-up. Results: A total of 101 children with simple hand injuries were included. Sixty-one participants completed the telephone survey. About 90% had no problems during healing and 85% resumed all activities. Ten participants requested follow-up; however, 4 cancelled and the remaining 6 required reassurance with no additional treatment. Conclusions: Most simple pediatric hand injuries heal well with buddy taping or splint immobilization. The described streamlined hand pathway can avoid unnecessary follow-ups for simple pediatric hand trauma, reducing the burden on both families and the healthcare system.

The Impact of Single-Use Cystoscopes on Clinical Time Workflow in an Outpatient Setting

ObjectiveTo evaluate the change in overall clinical encounter time and clinical capacity after transitioning to single-use cystoscopes (Ambu A/S, Ballerup, Denmark) in an outpatient urology setting. MethodsA single-institution prospective study in an outpatient urology procedure clinic was performed. Discrete categories for each portion of nursing care responsibilities were defined, and time spent during each category was recorded. Two separate clinic days were observed and analyzed: one where the clinic exclusively used reusable cystoscopes and the other after the transition to single-use cystoscopes occurred. Additionally, clinic schedules were reviewed from all procedure clinics in the 3-month periods before and after the transition to single-use cystoscopes. Outcomes included overall clinical encounter time and the number of procedures per clinic day. ResultsThere were 12 flexible cystoscopies performed during each of the observed clinic days. Preliminary cystoscope cleaning and transportation tasks by nursing staff were eliminated when utilizing single-use cystoscopes. Average total encounter time decreased from 66 to 44 minutes, resulting in a 34% reduction in clinical encounter time. The median number of flexible cystoscopy procedures increased after the transition from 9 (IQR 7-12) to 16 (IQR 11-17), representing a 78% increase (p=0.003). ConclusionsTransition to a completely single-use cystoscopy outpatient procedure clinic improved clinical efficiency and facilitated an increased number of procedures per clinic day.

Microstructural abnormality of white matter tracts in rheumatoid arthritis

BackgroundStructural and functional brain imaging studies have reported abnormalities of gray matter morphology and functional activities in patients with rheumatoid arthritis (RA). However, it is largely unknown whether patients with RA show alterations of white matter microstructural organization. ObjectivesTo automatically identify alteration of white matter microstructure in patients with RA and further examine how this alteration associates with clinical characteristics. MethodsThis single-institutional prospective study included 66 participants (33 patients with RA [52 ± 9 years, 29 women] and 33 sex/age-matched healthy controls [53 ± 12 years, 27 women]), who underwent diffusion MRI scan from January 2021 to December 2021. The white matter microstructure was assessed using fractional anisotropy, mean diffusivity, axial diffusivity, and radial diffusivity. Voxelwise analyses were conducted on white matter skeleton using an automated, observer-independent tract-based spatial statistics analysis. The relationship between white matter microstructural alterations and clinical and neuropsychological variables was evaluated using correlation analysis. ResultsCompared with healthy controls, patients with RA exhibited lower fractional anisotropy in several major white matter tracts (threshold-free cluster enhancement at P < 0.05 for multiple comparison correction, permutation test), involving the forceps minor, bilateral inferior fronto-occipital fasciculus, bilateral anterior thalamic radiation, and bilateral uncinate fasciculus. Lower fractional anisotropy values in the patients with RA were significantly associated with pain-related assessments, including tender joint count (r = -0.43, P = 0.015), Clinical Disease Activity Index score (r = -0.36, P = 0.049), pain severity rated through visual analogue scale (r = -0.45, P = 0.012), and Simplified Disease Activity Index score (r = -0.36, P = 0.045). No significant group difference was found in mean diffusivity, axial diffusivity, and radial diffusivity. ConclusionsWe report the first anatomical evidence for aberrant microstructure organization of several major white matter tracts and its associations with pain processing in patients with rheumatoid arthritis.

Comparison of Low-Dose Computed Tomography Versus Conventional-Dose Computed Tomography in the Evaluation of Distal Radius Fractures.

Distal radius fractures (DRFs) are common upper extremity fractures and often require surgical fixation when they are intraarticular. Preoperative computed tomography (CT) has emerged as a surgical planning tool to evaluate intraarticular DRFs. Although CT affords additional details, patients receive higher radiation doses than standard radiographs. We aim to develop a low-dose CT (LDCT) protocol, relative to the institutional standard-dose CT wrist for intraarticular DRFs although providing adequate detail for surgical decision-making. A single-institution prospective study was conducted on patients with intraarticular DRFs who underwent closed reduction and below-elbow splinting who otherwise would undergo wrist CT. Observations were defined as total measurements taken, with each view undergoing 44 measurements. Patients underwent 2 scans with a standard dose and a 10× dose reduction. Articular step and gap measurements were recorded in the sagittal and coronal images. A total of 11 patients were enrolled (7 women and 4 men). The mean age was 55 years (SD = 20.1). There were a total of 4 reviewers: 1 attending surgeon, 2 resident physicians, and 1 student. When comparing LDCT and conventional-dose CT (CDCT), there were no significant differences in step and gap measurements across all reviewers. This study demonstrated that LDCT provides comparable imaging quality for surgical planning as a CDCT without significant diagnostic decay in the setting of DRFs. This comes with the added benefit of a 10-fold reduction in radiation exposure. These results suggest that LDCT is an opportunity to reduce effective radiation in patients although providing beneficial preoperative imaging.

21 Gy single fraction prostate HDR brachytherapy: 5-year results of a single institution prospective pilot study

PURPOSETo present the outcome and toxicity results of a prospective trial of 21 Gy single fraction high-dose-rate (HDR) brachytherapy for men with low- or intermediate-risk prostate cancer. METHODS AND MATERIALSPatients were treated according to an IRB-approved prospective study of single fraction HDR brachytherapy. Eligible patients had low- or intermediate-risk prostate cancer with tumor stage ≤ T2b, PSA ≤ 15, and Gleason score ≤ 7. Patients underwent trans-rectal ultrasound-guided trans-perineal implant of the prostate followed by single fraction HDR brachytherapy to a dose of 21 Gy. The primary endpoint was grade ≥ 2 urinary/GI toxicity rates. RESULTSTwenty-six patients were enrolled with a median follow up of 5.1 years and median age of 64 years. 88.5% of patients had T1 disease, 15.4% had Gleason score 6 (84.6% Gleason 7), and median pre-treatment PSA was 5.0 ng/mL. Acute and chronic grade ≥ 2 urinary toxicity rates were 38.5% and 38.5%, respectively. There were no grade ≥ 2 acute or chronic GI toxicities. Six (23.1%) patients experienced biochemical failure, six (23.1%) patients experienced radiographic local failure, and five (19.2%) patients had biopsy-proven local failure. No patients developed regional lymph node recurrence or distant metastasis. 5-year overall survival and cause-specific survival were 96.2% and 100%, respectively. CONCLUSIONS21 Gy single fraction HDR brachytherapy was associated with modestly higher-than-anticipated chronic urinary toxicity, as well as high biochemical and local failure rates. The results from this prospective pilot study do not support the use of this regimen in standard clinical practice.

Telemedicine for Multidisciplinary Urologic Cancer Care: A Prospective Single Institution Study

BackgroundWe rapidly implemented a telemedicine Multidisciplinary Urologic Cancer Clinic (MDUCC) at the University of Washington/Seattle Cancer Care Alliance during the peak of the COVID-19 Public Health Emergency to maintain our ability to provide multidisciplinary cancer care. We report our experiences though assessment of patient-reported outcomes from our telemedicine MDUCC. MethodsVideo visits with a urologic oncologist, medical oncologist, and radiation oncologist were conducted in the same format as our in-person MDUCC. We prospectively collected patient demographic and clinical data. Patients were invited to complete a post-visit survey that assessed satisfaction, provider trust, travel time, and costs of the telemedicine visit. We estimated travel distances and times from each patient's home to our clinic. ResultsAmong invited patients, twenty-four patients completed a survey after their telemedicine MDUCC visit. Twenty patients (83%) were at home during the visit. Most (85%) were men, Caucasian (79%), and were being seen in our Bladder Cancer MDUCC (83%). All twenty-four patients responded that they would be willing to have future appointments via telemedicine; eighteen patients (75%) strongly agreed that the encounter was high quality; 19 patients strongly agreed that they were satisfied with their visit. Patients saved an estimated average one-way travel distance of 145 miles and one-way travel time of 179 minutes to convene a telemedicine visit. ConclusionsTelemedicine MDUCCs are feasible and effective in providing access to multidisciplinary urologic cancer care. Patient satisfaction was high, and many patients were spared a substantial travel burden. Telemedicine may continue to be leveraged to improve access to multidisciplinary urologic cancer care.

LINAC-based SBRT in treating early-stage NSCLC patients-single institution experience and survival data analysis.

Aim: This single institute prospective study aimed to evaluate the feasibility of LINAC-based stereotactic body radiotherapy (SBRT) in treating patients with early-stage non-small cell lung cancer (NSLSC). We focused on the survival data with the local and distant control profiles and the cancer- and non-cancer-specific survival. Treatment-related side effects were also collected and analyzed. Methods: Patients with early-stage NSCLC between January 2018 and October 2021 were included in our prospective study; a total of 77 patients receiving LINAC-based SBRT were analyzed. All patients had pretreatment multidisciplinary tumor board decisions on SBRT. The average patient age was 68.8years (median: 70years, range: 52-82); 70 patients were in ECOG 0 status (91%), while seven patients were in ECOG 1-2 status (9%). 52% of the patients (40) had histologically verified NSCLC, and the other 48% were verified based on PETCT results. We applied the SBRT scheme 8 x 7.5 Gy for central tumors (74%) or 4 x 12 Gy for peripheral tumors (26%). Results: The mean follow-up time was 25.4months (median 23, range 18-50). The Kaplan-Meier estimation for overall survival in patients receiving LINAC-based SBRT was 41.67months. Of the 77 patients treated by SBRT, death was reported for 17 patients (9 cases cancer-specific, 8 cases non-cancer specific reason). The mean local tumor control was 34.25months (range 8.4-41), and the mean systemic control was 24.24months (range 7-25). During the treatments, no Grade I-II were reported; in 30 cases, Grade I non-symptomatic treatment-related lung fibrosis and two asymptomatic rib fractures were reported. Conclusion: In the treatment of early-stage NSCLC, LINAC-based SBRT can be a feasible alternative to surgery. Although we reported worse OS data in our patient cohort compared to the literature, the higher older average age and the initial worse general condition (ECOG1-2) in our patient cohort appear to be the reason for this difference. With the comparable local control and survival data and the favorable side effect profile, SBRT might be preferable over surgery in selected cases.

A Single-Institution Prospective Study To Evaluate the Safety and Efficacy of Real- Time Image-Gated Spot-Scanning Proton Therapy (RGPT) for Prostate Cancer

BackgroundIn Real-time-image Gated spot-scanning Proton Therapy (RGPT), the dose distribution is distorted by gold fiducial markers placed in the prostate. Distortion can be suppressed by using small markers and more than two fields, but additional fields may increase the dose to organs at risk. Therefore, we conducted a prospective study to evaluate the safety and short-term clinical outcome of RGPT for prostate cancer. MethodsBased on the previously reported frequency of early adverse events (AE) and the non-inferiority margin of 10%, the required number of cases was calculated to be 43 using the one-sample binomial test by the SWOG statistical tools with the one-sided significance level of 2.5% and the power 80%. Patients with localized prostate cancer were enrolled and 3-4 pure gold fiducial markers of 1.5 mm diameter were inserted in the prostate. The prescribed dose was 70 Gy(RBE) in 30 fractions, and treatment was performed with three fields from the left, right, and the back, or four fields from either side of slightly anterior and posterior oblique fields. The primary endpoint was the frequency of early AE (≥ Grade 2) and the secondary endpoint was the biochemical relapse-free survival rate (BRFS) and the frequency of late AE. ResultsForty-five cases were enrolled between 2015 and 2017 and all patients completed the treatment protocol. The median follow-up period was 63.0 months. The frequency of early AE (≥ Grade 2) was observed in 4 cases (8.9%), therefore the non-inferiority was verified. The overall 5-year BRFS was 88.9%. As late AE, Grade 2 rectal bleeding were observed in 8 cases (17.8%). ConclusionsThe RGPT for prostate cancer with 1.5 mm markers and 3- or 4- fields was as safe as conventional proton therapy in early AE, and its efficacy was suggested comparable with previous studies.

Optimization of intraoperative lumpectomy specimen labeling

BackgroundAccurate lumpectomy specimen orientation is critical as incorrect orientation may result in excision of the wrong lumpectomy margin. Our goal was to determine if specimen orientation achieved by labeling three surfaces is superior to two. MethodsThis was a prospective single-institution study including 22 breast surgical oncologists. Intraoperative labeling of either two or three surfaces of the lumpectomy specimen was based on surgeon preference. The specimen was delivered to Pathology where it was oriented by the pathology team and the surgeon then determined if the specimen was correctly oriented or if re-orientation was required. Surgeons subsequently recorded orientation technique and if re-orientation was required. Specimen weight, patient age, and BMI were recorded. Fisher’s exact test and two-sample Wilcoxon rank-sum test were used to determine p-values. ResultsOf 268 specimens, 40 (14.9%) required re-orientation. Labeling specimens on three surfaces was superior to two (22 of 195 (11.2%) versus 18 of 73 (24.6%), p = 0.01). Specimens requiring re-orientation were more likely to be heavier (36 g vs. 24 g, p = 0.02). In multivariable analysis, labeling specimens on three surfaces resulted in a 70% reduction in discordance rates between the surgeon and pathology team (OR 0.3, p = 0.001). Using mean weight of lumpectomy specimens, specimens >33 g were more likely to require reorientation (OR 2.8, p = 0.004). Age and BMI did not impact the need for re-orientation. ConclusionLumpectomy specimen labeling using three surfaces was superior to two. Surgeons should routinely orient their specimens on three or more surfaces to decrease discordance rates.

Germline pathogenic variants in universal screening of genitourinary malignancies: A multisite single institution prospective study.

376 Background: Germline genetic testing (GGT) is becoming increasingly important in the management of genitourinary (GU) malignancies as novel targeted drug therapies emerge. Selection for genetic studies and testing has historically been highly selective and based on pathologic characteristics, family history, and age of diagnosis. The aim of our study was to investigate the prevalence of pathogenic variants (PGVs) in inherited cancer susceptibility genes utilizing a universal testing approach and to characterize the rate of PGVs that would have been missed based on current NCCN guidelines. Methods: A multisite single-institutional prospective study (INTERCEPT) offered GGT to all patients with new or active diagnoses of GU malignancies (bladder, prostate, and renal cancers) from April 1, 2018 to March 31, 2020 at Mayo Clinic Arizona, Mayo Clinic Florida and Mayo Clinic Rochester. Participants were offered GGT with a panel of &gt;80 genes through Invitae Corp. Demographic, tumor characteristics and genetic results were evaluated. PGVs were classified as high-, intermediate-, or low- penetrance variants based on published literature. Respective NCCN GU GGT guidelines were used to determine if the PGVs discovered using our universal testing approach would have been missed with guideline-directed GGT. Results: A total of 3095 pan-cancer patients were enrolled in the study; 601 of which had a GU malignancy including: prostate cancer (358 patients), renal cancer (137), and bladder cancer (106). The mean age of enrollment was 66.8 years (SD 9.1), 89% were male, and 85.9% of patients were Non-Hispanic white. PGVs were identified in 82 of all GU patients (13.6%) and variants of undetermined significance (VUS) in 289 (48.1%) patients. PGV prevalence breakdown by cancer type was: 13.7% of prostate, 13.1% renal, and 14.2% bladder cancer patients. The proportion of high penetrance PGVs varied by malignancy type. Of all patients, 326 (54.2%) had advanced (stage III/IV) disease and 377 (64.4%) of these were metastatic upon initial evaluation. The majority of all PGVs identified were incremental, defined as PGVs that would not have been identified based on guideline-concordant GGT: 100% (15/15 patients) with bladder, 77.8% (14/18) with renal, and 57.1% (28/49) with prostate cancer. Conclusions: Universal GGT for prostate, renal and bladder cancer revealed that over 1 in 10 patients harbored potentially actionable PGVs, most of which would not have been identified with guidelines-based GGT. Utilization of GGT can impact our understanding of GU cancer pathogenesis, aid in familial cascade testing, and influence treatment decisions.

Oral glutamine: Is there a role in the amelioration of radiation-induced mucositis? A prospective case-control study at a tertiary care centre in North India.

The most frequently occurring painful and dose-limiting side effect of radiation therapy (RT) to the head and neck region is oral mucositis (OM). Several studies demonstrated that glutamine may reduce the severity and the duration of OM significantly during RT and chemo-radiotherapy in patients with head and neck cancer (HNC). Between January 2021 and August 2022, a prospective single institutional case-control study compared the efficacy and safety of oral glutamine on radiation-induced mucositis in patients with HNC. Of 60 biopsy-proven patients with HNC, 30 patients in the study arm received oral glutamine suspension (10 g in 500 mL of water) orally once daily, 2 hours before RT, receiving definitive or adjuvant RT and chemo-radiotherapy, while as 30 patients in the control arm received placebo with the same dose and schedule (n = 30 in the study arm and n = 30 in the control arm). A total of 27 (90%) in the glutamine arm and 28 (93.33%) patients in the control arm developed mucositis. Grade 3 mucositis (13.33%) and Grade 4 mucositis (6.66%), respectively, were significantly less (P = .040 and P = .004) in the glutamine arm. The mean duration of grade 3 and grade 4 mucositis was significantly less in the glutamine arm (8.94 days in the study arm vs. 14.54 in the control arm; P = .0001). The mean time of onset of OM was significantly delayed in the glutamine arm in comparison to the control arm with P < .001. Glutamine delays the onset of OM and decreases the severity of OM in patients of HNC receiving RT with or without chemotherapy.

D-dimer and sinusoidal obstructive syndrome-novel poor prognostic features of thrombotic microangiopathy in children after hematopoietic cellular therapy in a single institution prospective cohort study.

Transplant-associated thrombotic microangiopathy (TA-TMA) is a common, severe complication of allogeneic hematopoietic cellular therapy (HCT). Even when treated in many studies, morbidity and mortality rates are high. This prospective single-institution cohort study serially enrolled all allogeneic HCT recipients from August 2019-August 2022. Patients were universally screened for TA-TMA and intermediate and high-risk patients were immediately treated with eculizumab. Sub-distribution cox-proportional hazards modelswere used to identify sub-distribution hazard ratios (sHR) for multi-organ dysfunction (MOD) and non-relapse-related mortality (NRM). Of 136 patients, 36 (26%) were diagnosed with TA-TMA and 21/36 (58%) developed MOD, significantly more than those without TA-TMA, (p < .0001). Of those with TA-TMA, 18 (50%) had high-risk TA-TMA (HR-TA-TMA), 11 (31%) had intermediate-risk TA-TMA (IR-TA-TMA), and 8 (22%) had standard risk (SR-TA-TMA). Twenty-six were treated with eculizumab (1/8 SR, 7/11 IR, and 18/18 HR). Elevated D-dimer predicted the development of MOD (sHR 7.6, 95% confidence interval [CI] 1.8-32.3). Children with concurrent sinusoidal obstructive syndrome (SOS) and TA-TMA had an excess risk of MOD of 34% and data supported a biologic interaction. The adjusted NRM risk was significantly higher in the TA-TMA patients (sHR 10.54, 95% CI 3.8-29.2, p < .0001), despite prompt treatment with eculizumab. Significant RF for NRM in TA-TMA patients included SOS (HR 2.89, 95% 1.07-7.80) and elevated D-dimer (HR 3.82, 95% CI 1.14-12.84). An unrelated donor source and random urine protein to creatine ratio ≥2 mg/mg were significantly associated with no response to eculizumab (odds ratio 15, 95% CI 2.0-113.6 and OR 6.5, 95% CI 1.1-38.6 respectively). TA-TMA was independently associated with NRM despite early diagnosis and treatment with eculizumab in this large pediatric transplant cohort. Prognostic implications of D-dimer in TA-TMA merit further investigation as this is a readily accessible biomarker. Concurrent SOS is an exclusion criterion of many ongoing clinical trials, but these data highlight these patients could benefit from novel therapeutic approaches. Multi-institutional clinical trials are needed to understand the impact of TA-TMA-targeted therapies.

Marijuana and Endoscopy: The effects of marijuana on sedation

Background and AimsMarijuana usage has increased significantly as it has become more readily available and legal, either recreationally or medicinally, in many states. It has been postulated that marijuana usage increases the amount of sedation required for procedures. However, there is minimal data defining this relationship. We aim to establish the relationship between marijuana usage and the amount of sedation used during endoscopy. MethodsThis was a single institution prospective study of patients undergoing outpatient endoscopy (both Monitored Anesthesia Care (MAC) and moderate sedation) at the Oklahoma City Veterans Affairs Medical Center with a total of 976 patients participating. Marijuana usage was assessed by a voluntary de-identified pre-endoscopy survey. Information regarding sedation used, endoscopy outcomes, demographics, comorbidities, medical history, and medications used were extracted from the medical record. A univariate and stratified analysis of alcohol usage was performed. A P-value < 0.05 was considered significant. Results976 patients were analyzed. 21.5% of the patients endorsed marijuana usage (210/976). Marijuana users were found to be younger (p=0.0002), leaner (p<0.0001), and less likely to have diabetes (p=0.002), obstructive sleep apnea (p=0.0002) and hypertension (p=0.04). They were also more likely to smoke (p<0.0001) and vape (p<0.0001). Marijuana usage was associated with a higher requirement of sedation (Fentanyl [p=0.003]; Midazolam [p=0.05]; propofol [p=0.02]) and higher use of adjunct sedation (Diphenhydramine in moderate sedation (p=0.0003)). Further multivariate analyses were performed to control for possible confounders. Marijuana usage was still deemed to be an independent predictor for high propofol use among MAC cases (OR = 1.77, 95% CI [1.00, 3.12]). Likewise, marijuana usage was found to be an independent predictor for high midazolam use (OR = 1.57, 95% CI [1.02, 2.42]) and high fentanyl use (OR = 1.54, 95% CI [0.98, 2.38]) but failed to reach statistical significance in the fentanyl group. ConclusionMarijuana use is associated with a significantly higher amount of sedation along with a significantly higher usage of other adjunct sedatives. A patient’s marijuana history should be considered when determining the methods of sedation to be used for endoscopy.

Frailty screening for determination of hemodialysis access placement

ObjectiveChoosing the right hemodialysis vascular access for frail patients remains difficult because the patient's preferences and the likelihood of access function and survival must be considered. We hypothesize that patients identified before arteriovenous (AV) access as frail by the PRISMA-7 score may have worse outcomes, indicating that fistula creation may not be the most clinically beneficial option and it would be in the best interest of the patient to receive either AV graft (AVG) placement or dialysis through a percutaneous catheter. Our pilot study aims to determine whether an association exists between patient frailty as defined by PRISMA-7 and newly created AV fistula (AVF) and AVG access outcomes. MethodsThis was a single institutional prospective cohort study of patients undergoing new AVF or AVG intervention from April 2021 to May 2023. Patients were assessed using the PRISMA-7 frailty questionnaire before their AV access surgery. Patients were grouped by frailty score and score groups were examined for trends. Univariable analysis was performed for baseline differences between frail and nonfrail patients. Failure to achieve maturation, postoperative infection, and 180-day mortality difference was also investigated for frail vs nonfrail patients. Univariable analysis was performed for nonmaturation using standard comorbidities, arterial and venous diameters, and frailty. Multivariable binary logistic regression was performed for the outcome of nonmaturation using frailty as one of the variables in conjunction with the univariable risks associated with nonmaturation. ResultsA total of 40 patients undergoing new AV access placement were investigated, among whom 53% were designated as frail (PRISMA-7 score ≥3). When comparing the frail and nonfrail new AV access groups, the access (AVF and AVG combined) failed in 48% (10/21) of the frail patients, but only failed in 5% (1/19) of the nonfrail patients 1 (P = .012). When distinguishing between AV access types, AVF creations followed the overall trend with 60% of AVF access (9/15) sites in frail patients failing to mature when compared with nonfrail patients, who all had fistulas that matured to use (P = .049). Surgical site infection was absent in all frail patients and present in 5% of nonfrail patients (1/19). Both 30-day and 60-day readmission rates were higher in the frail group compared with the nonfrail group. There was 180-day mortality present in 5 of frail patients % (1/21) and absent in nonfrail patients. Multivariable analysis revealed that both frailty (adjusted odd ratio, 10.19; 95% confidence interval, 1.20-82.25); P = .033) and younger age (adjusted odd ratio, 0.953; 95% confidence interval, 0.923-0.983; P = .002) both had a significant association with nonmaturation. Power analysis revealed a power statistic of 0.898 indicating a probability of type 2 error of 10.02% with a P value of .002. Hosmer-Lemeshow goodness of fit for the logistic regression had 75% overall accuracy for the model. ConclusionsPatient frailty is significantly associated with an increased incidence of AV access failure to mature.

Surgical Margin of Resected Colorectal Liver Metastases:: How Accurate is Surgeon Prediction?

The aim of this study was to describe the surgeon's ability to accurately predict the margin following resection of colorectal liver metastases (CRLM). The decision to resect CRLM is based on the surgeon's ability to predict tumor free resection margins. However, to date, no study has evaluated the accuracy of surgeon margin prediction. In this single-institution prospective study, the operating attending and fellow independently completed a preoperative and postoperative questionnaire describing their expected resection margin in 100 consecutive cases (200 assessments) of colorectal liver metastasis resections. In cases with multiple metastases, the closest margin was assessed as the margin of interest for the primary outcome. Surgeon assessments were compared to the gold-standard histopathologic assessment. After excluding aborted cases, 190 preoperative and 190 postoperative assessments from 95 cases were included in the analysis. The pathologic margin was noted to be wide (≥1cm), 1mm to 1cm, narrow (<1mm), and positive in 28 (29.5%), 55 (57.9%), 5 (5.3%), and 7 (7.4%) cases, respectively. The 88 cases with negative margins were all predicted to be negative. None of the cases with positive margins were predicted to be positive. Ninety-one (48%) preoperative and 104 (55%) postoperative predictions were accurate. The sensitivity of predicting a margin <1mm was 8.3% preoperatively and 16.7% postoperatively. The positive predictive value for preoperative and postoperative predictions of margin <1mm was 18.2% and 26.7%, respectively. Surgeons are inaccurate at predicting positive and close surgical margins following resection of CRLM. A predicted close margin should not necessarily preclude resection.

Objective improvement in dexterity for trainees undergoing a video-assisted thoracoscopic surgery simulation program, a prospective single center study.

Video-assisted thoracoscopic surgery (VATS) is the recommended approach for the management of early-stage operable non-small cell lung carcinoma as well as for other pathologies of the thoracic cavity. Although VATS approaches have been largely adopted in Europe and North America, teaching the technique to novice thoracic surgery trainees remains challenging and non-standardized. Our objective was to assess the impact of a VATS simulation training program on the dexterity of thoracic surgery residents in a prospective single institution study. We developed a 6-month VATS simulation training program on two different dry-lab simulators (Johnson & Johnson Ethicon Stupnik® lobectomy model; CK Surgical Simulation® Crabtree perfused lobectomy model) and assessed the skills of first year thoracic surgery residents (study group, n=7) before and after this program using three standardized exercises on the Surgical Science Simball® Box (peg placement on a board, rope insertion in loops, precision circle cutting). The results were compared to those of last-year medical students who performed the same Simball® Box exercises at a 6-month interval without undergoing a training program (control group, n=5). For each participant, the travel distances of instruments, operation time and absences of periods of extreme motion were assessed for each exercise by the use of the computer-based evaluation of the Simball® Box. After the 6-month VATS training program, all residents revealed a significant increase of their performance status with respect to instrument travel distances operation times and absence of periods of extreme motion in all three exercises performed. The performance of the control group was not different from the study group prior to the training program and remained unchanged 6 months later, for all exercises and parameters assessed. Our results suggest that the implementation of a VATS simulation training program objectively increases the dexterity of thoracic surgery residents and could be an interesting training tool for their surgical education.

Assessment and comparison of quality of life and sexual function after adjuvant therapy in post-mastectomy breast carcinoma: A prospective study

Background: Quality of life (QoL) is an important measure in the evaluation of health, physical condition, and the effects of treatment and continues to gain importance. Health-related QoL gives information about the patient’s experiences (physical and psychological) related to the disease and the applied treatments, as well as the potential prognosis. It is known that breast surgery and its combination with chemotherapy (CT) and radiation therapy causes negative changes in the patient’s psychosocial well-being and QoL. Aims and Objectives: To study the QoL and sexual function in female breast carcinoma patients who received adjuvant CT and radiation therapy after mastectomy. Materials and Methods: This was a single institutional prospective study carried out in the Department of Radiotherapy, RG Kar Medical College and Hospital, Kolkata. From January 2017 to December 2019, according to inclusion and exclusion criteria, a total of 64 histologically proven breast carcinoma patients were included in this prospective study. Results: On symptom scale analysis, it has been noted that all the symptoms increased after receiving CT and reached their highest after the 6th cycle of CT, then improved after radiation and further improved at 6 months follow-up, except for the breast symptoms, which decreased after the 6th cycle of CT, increased immediately post-RT, and then again decreased at 6 months follow-up. Conclusion: Treatment with CT and radiation therapy significantly affects QoL, psychosexual function, and physical problems.

Health Outcome Preferences Among Older Adults with Multiple Myeloma Undergoing Systemic Therapy

Introduction: Multiple Myeloma (MM) is the second most common hematologic malignancy in the US; over half of patients are ≥70y at diagnosis. Prior studies have shown that treatment preferences of older adults with cancer vary based on burden/intensity of current treatment and its impact on functional and cognitive well-being in addition to anticipated survival. However, no such studies exist among older adults with MM. We sought to understand health outcome preferences in a cohort of older adults with MM. Methods: Using the Cancer and Aging Resilience Evaluation in Hematologic Malignancies Registry (NCT05556928), a single institution prospective observational study of older adults with hematologic malignancies undergoing systemic therapy, we identified patients diagnosed with multiple myeloma at age ≥50y who had undergone a geriatric assessment (GA) within 30 days of initiating a new line of therapy (1 st to 5 th line).Treatment preference was assessed using a 9-item health outcome preference attitude scale (Case et al Patient Educ Couns 2013), rating self-reported agreement with statements related to health outcomes on a Likert scale. Frailty was assessed using a deficit accumulation method as previously described (Giri S et al J Am Geriatr Soc 2023) We measured the proportion of patients reporting other outcomes being “as important” or “more important” than survival and compared the response between younger (&amp;lt;70y) and older (≥70y) adults. Subsequently, we built proportional odds models to study the factors associated with a greater prioritization of outcomes other than survival. All p values were two sided and the level of significance was chosen at 0.05. Results: Of the 228 patients initiating a new line of therapy between 01/2022 to 4/2023, 104 (47%) underwent treatment preference assessment. The median age at enrollment was 65y with 33% ≥70y; 62% were males, 57% whites; 19% had ISS stage 3 disease; 28% were frail on the CARE frailty index. In the younger (age &amp;lt;70y) vs older (age ≥70y) patients, 32% vs 77% agreed/strongly agreed with: “I would rather live a shorter life than lose my ability to take care of myself”; and 54% vs 79% agreed/strongly agreed with: “It is more important to me to maintain my thinking ability than to live as long as possible”. In multivariable models, age but not frailty, sex, race or disease stage were associated with health outcome prioritization other than survival. Each 1y increase in age was associated with and 8% (Odds Ratio 1.08; 95% CI 1.03-1.13; p value=0.001) and 4% (OR 1.04; 95% CI 1.0-1.09; p value=0.04) increased odds of rating functional independence and cognition respectively as more important than survival. Conclusions: Three out of four older adults (age&amp;gt;70y) with MM rated other outcomes (particularly physical function and cognitive ability) as being more important than survival. Eliciting which outcomes are the most important for older patients can help define treatment goals and improve shared decision-making. Further, interventions focusing on preserving physical and cognitive function need to be tested in this population.

Setup Uncertainty of Pediatric Brain Tumor Patients Receiving Proton Therapy: A Prospective Study.

This study quantifies setup uncertainty in brain tumor patients who received image-guided proton therapy. Patients analyzed include 165 children, adolescents, and young adults (median age at radiotherapy: 9 years (range: 10 months to 24 years); 80 anesthetized and 85 awake) enrolled in a single-institution prospective study from 2020 to 2023. Cone-beam computed tomography (CBCT) was performed daily to calculate and correct manual setup errors, once per course after setup correction to measure residual errors, and weekly after treatments to assess intrafractional motion. Orthogonal radiographs were acquired consecutively with CBCT for paired comparisons of 40 patients. Translational and rotational errors were converted from 6 degrees of freedom to a scalar by a statistical approach that considers the distance from the target to the isocenter. The 95th percentile of setup uncertainty was reduced by daily CBCT from 10 mm (manual positioning) to 1-1.5 mm (after correction) and increased to 2 mm by the end of fractional treatment. A larger variation existed between the roll corrections reported by radiographs vs. CBCT than for pitch and yaw, while there was no statistically significant difference in translational variation. A quantile mixed regression model showed that the 95th percentile of intrafractional motion was 0.40 mm lower for anesthetized patients (p=0.0016). Considering additional uncertainty in radiation-imaging isocentricity, the commonly used total plan robustness of 3 mm against positional uncertainty would be appropriate for our study cohort.