Preoperative Marking Research Articles

Diagnosis and management of indeterminate testicular lesions.

The sophistication and accessibility of modern-day imaging result in frequent detection of small or equivocal lesions of the testes. Traditionally, diagnosis of a testicular lesion with any possibility of malignancy would usually prompt radical orchidectomy. However, awareness is growing that a substantial proportion of these lesions might be benign and that universal application of radical orchidectomy risks frequent overtreatment. Given the potentially profound effects of radical orchidectomy on fertility, endocrine function and psychosexual well-being, particularly in scenarios of an abnormal contralateral testis or bilateral lesions, organ-preserving strategies for equivocal lesions should be considered. Image-based active surveillance can be applied for indeterminate lesions measuring ≤15 mm with a low conversion rate to surgical treatment. However, these outcomes are early and from relatively small, selected cohorts, and concerns prevail regarding the metastatic potential of even small undiagnosed germ cell tumours. No consensus exists on optimal surveillance (short interval (<3 months) ultrasonography is generally adopted); histological sampling is a widespread alternative, involving inguinal delivery of the testis and excisional biopsy of the lesion, with preoperative marking or intraoperative ultrasonographic localization when necessary. Frozen section analysis in this context demonstrates excellent diagnostic accuracy. Histological results support thatapproximately two-thirds of marker-negative indeterminate solitary testicular lesions measuring ≤25 mm overall are benign. In summary, modern imaging detects many small indeterminate testicular lesions, of which the majority are benign. Awareness is growing of surveillance and organ-sparing diagnostic and treatment strategies with the aim of minimizing rates of overtreatment with radical orchidectomy.

Patient Satisfaction and Scar Quality Following Upper Blepharoplasty Using a Simplified Preoperative Marking Technique.

One of the most popular plastic surgical interventions both abroad and in Kazakhstan is blepharoplasty. Plastic surgeons continue to debate various methods for performing this operation; however, some of the methods used by plastic surgeons for preoperative marking of the upper eyelid skin may not be suited to the type of incision that should be used on the eyelids of individuals from Kazakhstan. For this reason, the surgery may not achieve the desired results. We conducted a study of patients from Kazakhstan who underwent upper blepharoplasty using a simplified technique for eyelid marking that we developed at our plastic surgery center. We used the Patient-Reported Outcome Measure Questionnaire (PROM-Q) to measure patient satisfaction and the Patient and Observer Scar Assessment Scale (POSAS) to measure scar quality. The results of our study showed that the majority of patients who underwent upper blepharoplasty performed by surgeons using our method of preoperative marking were extremely satisfied with the effect. The patients noted rapid tissue repair and minimal scarring. We concluded that the use of a simplified marking technique can significantly help aesthetic surgeons performing upper blepharoplasty by reducing the risk for negative postoperative effects.

Standardization of preoperative stoma site marking and its utility for preventing stoma leakage: a retrospective study of 519 patients who underwent laparoscopic/robotic rectal cancer surgery.

Stoma site marking is an important preoperative intervention for preventing various stoma-associated complications. In our institution, standardized stoma site marking is routinely performed before rectal cancer surgery with stoma creation, and various stoma-associated factors are recorded in the ostomy-record template. The present study investigated risk factors for stoma leakage. Our stoma site marking is standardized so that it can be performed by non-stoma specialists. To identify risk factors of stoma leakage at 3months after surgery, various preoperative factors associated with stoma site marking in our ostomy-record template were retrospectively analyzed in 519 patients who underwent rectal cancer surgery with stoma creation from 2015 to 2020. Stoma leakage was seen in 35 of the 519 patients (6.7%). The distance between the stoma site marking and the umbilicus was less than 60mm in 27 of the 35 patients (77%) who experienced stoma leakage, so a distance of less than 60mm was identified as an independent risk factor for stoma leakage. Aside from preoperative factors, stoma leakage was also caused by postoperative skin wrinkles or surgical scars near the stoma site in 8 of 35 patients (23%). Preoperative standardized stoma site marking is necessary to achieve reliable marking that is easy to perform. To reduce the risk of stoma leakage, a distance of 60mm or more between the stoma site marking and the umbilicus is ideal, and surgeons need to contrive ways to keep surgical scars away from the stoma site.

Planning the approach in mini percutaneous nephrolithotripsy according to individual kidney anatomy detected by computed tomography

Aim to analyze postoperative complications after mini percutaneous nephrolithotripsy, taking into account an assessment of individual variations of kidney anatomy.&#x0D; Material and methods. Postoperative complications after mini percutaneous nephrolithotripsy were analyzed in 60 patients who underwent preoperative CT urography with intravenous bolus contrast and 3D reconstruction.&#x0D; Results. We found no significant correlation between the number of complications after mini percutaneous nephrolithotripsy and the type of division of the branches of the renal artery of the 2nd order, as well as no dependence of the occurrence of complications on the presence of accessory arteries. A moderate correlation between the number of complications and the number of accesses was noted.&#x0D; Conclusion. In mini percutaneous nephrolithotripsy, the preoperative planning and marking of the access trajectory can significantly reduce the number of postoperative complications.

Impact of Preoperative Stoma Site Marking on Morbidity and Mortality in Patients with Colorectal Perforation: A Nationwide Retrospective Cohort Study.

Preoperative stoma site marking reduces the incidence of complications from elective surgery. However, the impact of stoma site marking in emergency patients with colorectal perforation remains unclear. This study aimed to assess the impact of stoma site marking on morbidity and mortality in patients with colorectal perforation who underwent emergency surgery. This retrospective cohort study used the Japanese Diagnosis Procedure Combination inpatient database from April 1, 2012, to March 31, 2020. We identified patients who underwent emergency surgery for colorectal perforation. We compared outcomes between those with and without stoma site marking using propensity score matching to adjust for confounding factors. The primary outcome was the overall complication rate, and the secondary outcomes were stoma-related, surgical, and medical complications and 30-day mortality. We identified 21,153 patients (682 with stoma site marking and 20,471 without stoma site marking) and grouped them into 682 pairs using propensity score matching. The overall complication rates were 23.5% and 21.4% in the groups with and without stoma site marking, respectively (p = 0.40). Stoma site marking was not associated with a decrease in stoma-related, surgical, or medical complications. The 30-day mortality did not differ significantly between the groups with and without stoma site marking (7.9% vs. 8.4%, p = 0.843). Preoperative stoma site marking was not associated with a reduction in morbidity and mortality in patients with colorectal perforation who underwent emergency surgery.

Surgical Marking Pen Contamination: Writing a Postoperative Infection Into Your Preoperative Plan.

Introduction Preoperative marking is an essential safety practice to prevent "never" events, including wrong site surgery. Moreover, the Joint Commission regulations of the Universal Protocol require that patients be marked to indicate the operative site. Marking typically occurs with a pen or marker, which may be disposable or reusable. Previous studies have demonstrated that methicillin-resistant Staphylococcus aureus (MRSA) can survive in the dark, moist, capped environment of the marking pen and thus could plausibly be a nidus for transmission from patient to patient. The Joint Commission has established no increased risk of postoperative infection with these markings. With this study, we aimed to determine the colonization of surgical marking pens in the plastic surgery population. Methods Two marking pens from five different attending plastic surgeons at a single institution were cultured in standard fashion for aerobic and anaerobic growth. All pens were used repeatedly in office settings for performing patient markings. Those same ten marking pens were then used to mark incision sites on mock patients. Standard povidone-iodine prepping was then performed in a paint-only fashion over the skin markings, and cultures were again taken. A control group consisted of cultures from five sterile pens from the operating room. Each sterile pen was opened, uncapped, and then swabbed. All twenty-five cultures were analyzed in the hospital laboratory in a blinded fashion. Results The five control pens revealed no bacterial growth. Of the 10 direct pen cultures, two samples grew coagulase-negative staphylococci and one culture contained Pseudomonas aeruginosa. The 10-patient marked and prepped specimens showed eight negative cultures and two with coagulase-negative staphylococci. Although Pseudomonas was detected on standard pen culture, no pseudomonal growth was present in any of the samples after patient marking and prepping with povidone-iodine. Conclusions Our findings reaffirm that marking pens may be vehicles for bacterial transmission and expand upon previous studies by describing the presence of bacterial colonization on marking pens even after surgical site preparation with povidone-iodine.

The Junction Between the Peristaltic and Non-peristaltic Bowel (Shore Break) is Found in the Transition Zone in Hirschsprung's Disease

BackgroundThe junction between the peristaltic and non-peristaltic bowel, which is named the “shore break” (SB), observed on endoscopy is thought to be the boundary between normal and abnormal motility in Hirschsprung's disease (HD). The transition zone (TZ), which is the histopathological border, does not have normal motility and should be resected. This study aimed to evaluate the histopathological findings of the SB and determine the association between the SB and TZ. MethodsA retrospective review of surgical specimens of patients with HD who underwent preoperative SB marking was conducted. The TZ was defined if nerve hypertrophy, myenteric hypoganglionosis, or partial circumferential aganglionosis was detected. ResultsTen patients (9 boys and 1 girl) were studied. The median age at surgery was 30 days. The median distance from the anal verge to the marked SB site was 14 cm. No patients manifested any obstructive symptoms resulting from a residual TZ bowel. In eight patients, nerve hypertrophy was identified at the proximal margin and at the SB. Myenteric hypoganglionosis was identified in three patients at the proximal margin and SB. Partial circumferential aganglionosis was identified at the SB in two patients. As a result, in all patients, the pull-through site and SB site had histopathological features indicating TZ. ConclusionsThe SB is located in the TZ. Our results suggest that the proximal part of the TZ has normal motility and that functional border points may be present in the TZ. Level of EvidenceIV.

The NIU (Nipple-Inframammary Fold-Upper Breast Border) Principle: Preoperative Marking of the Ideal Nipple Position in Augmentation Mastopexy.

Although the beauty of the breast depends on aesthetic proportions, the position of the nipple-areola complex (NAC) on the breast mound and in relation to the implant during breast augmentation or mastopexy augmentation is critical. In fact, lack of nipple position determination in relation to the breast footprint is a deficiency of most currently applied measurements and evaluation tools. The authors hereby present a simple formula that allows accurate and proper prediction of the ideal NAC positioning for every patient depending on the chosen implant in case of mastopexy augmentation, or revision mastopexy with exchange of implants. A prospective level IV analysis of all consecutive patients undergoing primary mastopexy augmentation or revision mastopexy with exchange of implants was performed between January of 2021 and January of 2022. Forty-eight consecutive patients were included in the study. The nipple-inframammary fold-upper breast border (NIU) principle was applied to all patients to determine the ideal position of the NAC. Patients were photographed preoperatively and postoperatively in a standardized manner. The main endpoint was to determine whether the NAC is located at the most projected point of the breast on follow-up. The NIU principle was applied to 48 patients between January of 2021 and January of 2022. Of those patients, 27 underwent primary augmentation mastopexy, and 21 underwent revision augmentation mastopexy with exchange of implants. The mean follow-up duration was 9.2 months (range, 6 to 18 months). All patients demonstrated proper NAC positioning on follow-up. The NIU principle is a simple and reliable method to determine the ideal NAC position during mastopexy augmentation or mastopexy with implant exchange. Therapeutic, IV.

Ultrasound Calculation of Fat Volume for Liposuction: A Clinical Software Validation.

Fat manipulation procedures such as liposuction contain a degree of subjectivity primarily guided by the surgeon's visual or tactile perception of the underlying fat. Currently, there is no cost-effective, direct method to objectively measure fat depth and volume in real time. Utilizing innovative ultrasound-based software, the authors aimed to validate fat tissue volume and distribution measurements in the preoperative setting. Eighteen participants were recruited to evaluate the accuracy of the new software. Recruited participants underwent ultrasound scans within the preoperative markings of the study area before surgery. Ultrasound-estimated fat profiles were generated with the in-house software and compared directly with the intraoperative aspirated fat recorded after gravity separation. Participants' mean age and BMI were 47.6 (11.3) years and 25.6 (2.3) kg/m2, respectively. Evaluation of trial data showed promising results following the use of a Bland Altman agreement analysis. For the 18 patients and 44 volumes estimated, 43 of 44 measurements fell within a confidence interval of 95% when compared with the clinical lipoaspirate (dry) volumes collected postsurgery. The bias was estimated at 9.15 mL with a standard deviation of 17.08 mL and 95% confidence interval between -24.34 mL and 42.63 mL. Preoperative fat assessment measurements agreed significantly with intraoperative lipoaspirate volumes. The pilot study demonstrates, for the first time, a novel companion tool with the prospect of supporting surgeons in surgical planning, measuring, and executing the transfer of adipose tissues.

Spontaneous regression of advanced transverse colon cancer with deficient mismatch repair: a case report

BackgroundSpontaneous regression (SR) of cancer occurs in 1 in 60,000–100,000 patients. This phenomenon has been reported in almost all cancer types, most commonly neuroblastoma, renal cell carcinoma, malignant melanoma, and lymphoma/leukemia. However, SR in colorectal cancer (CRC) is extremely rare, particularly in advanced cases. Hence, this report describes a very rare case of spontaneous regression of advanced transverse colon cancer.Case presentationA 76-year-old female with anemia was diagnosed with a type II well-differentiated adenocarcinoma in the middle transverse colon. Two months later, a second colonoscopy examination was performed for preoperative marking, and it revealed tumor shrinkage and a shift to type 0–IIc morphology. Endoscopic tattooing was then performed, followed by a laparoscopic partial resection of the transverse colon with D3 lymph node dissection. However, the resected specimen contained no tumor, and colonoscopy showed no tumor remnants in the remaining colon. Histopathological examination revealed mucosal regeneration and a mucus nodule in between the submucosal and muscular layers, with no cancer cells detected. Immunohistochemical analysis revealed the loss of MutL homolog 1 (MLH1) and postmeiotic segregation increased 2 (PMS2) expression in the cancer cells of biopsied specimens, suggesting deficient mismatch repair (dMMR). The patient continues to be followed up until 6 years postoperatively, and no recurrence has been observed. In this study, we also reviewed similar reported cases of spontaneous regression of cancer involving dMMR.ConclusionThis study presents a rare case of spontaneous regression of advanced transverse colon cancer wherein dMMR is strongly involved. However, further accumulation of similar cases is needed to elucidate this phenomenon and to develop new treatment strategies for CRC.

The Position of the Nipple Areola Complex in Breast Augmentation.

There is some controversy regarding whether the nipple-areola complex (NAC) is elevated, remains stable or is lowered in breast augmentation. There is a general belief that one can modulate its position depending on the implant chosen. In addition, many preoperative markings include elevating the arms to predict the final position of the NAC. To study the changes in the position of the NAC and determine whether the postoperative position of the NAC can be predicted preoperatively by elevating the arms. The authors included 45 patients. A three-dimensional (3D) scan was used to take basal (preop) and 12-month measurements with the patient's arms in abduction and elevated over the head. The distances measured were the sternal notch-nipple (SN-Ni), nipple-nipple (Ni-Ni) and nipple-inframammary fold (Ni-IMF) distances. With arms abducted, the SN-Ni distance increased by 6% when measured linearly, 8.5% when measured on the skin surface and 1% to 2% when measured on the sternal line. The Ni-ni distance increased by 9% (linear) and 15% (over the surface). The Ni-IMF increased by 44%. With the arms adducted, the SN-Ni distance increased by 9% (linear), 12% (on the skin surface) and 0.5% at the sternal midline projection. The Ni-n distance increased 11% (linear) and 19% (on the surface). The Ni-IMF distance increased by 53%. The postoperative position of the NAC with the arms abducted increased by 17% compared to the preoperative position in adduction. Implants do not elevate the NAC; its position remains nearly unaltered. The Sn-n distance was increased in 90% of the patients. Lifting the arms for preoperative markings does not help to predict the postoperative position of the NAC.

Alternative donor sites in autologous breast reconstruction: a clinical practice review of the PAP flap.

Breast cancer is currently the most common cancer in female patients in the United States and around the world, with over 2 million new cases of breast cancer diagnosed in 2020. Subsequently, breast reconstruction after mastectomy is also becoming increasingly common. While not every patient elects to undergo reconstruction after mastectomy, many patients desire reconstruction with either implant-based or autologous tissue. In certain patients, autologous reconstruction can offer a multitude of advantages over implant-based reconstruction. While abdominally-based free flaps such as the deep inferior epigastric perforator (DIEP) flap have become the flap of choice for breast reconstruction, the profunda artery perforator (PAP) flap is a strong alternative for patients in which abdominally-based flaps are contraindicated or insufficient. This clinical practice review aims to summarizes the history of the PAP flap, describe relevant anatomy and characteristics of the PAP flap that make it a well-suited option in breast reconstruction. It will also provide clinical pearls related to pre-operative preparation, markings, and surgical technique involved in ensuring successful perforator dissection, flap harvest, inset, and survival. Finally, this review will discuss current literature published on PAP flaps to determine post-operative clinical outcomes, complications, and patient reported outcomes associated with PAP flap breast reconstruction.

Preoperative Tomographic Needle Marking: A Novel Level Localization Method to Avoid Wrong-Level Spine Surgery in Upper Thoracic Lesions

Preoperative Tomographic Needle Marking: A Novel Level Localization Method to Avoid Wrong-Level Spine Surgery in Upper Thoracic Lesions

A retrospective study of preoperative CT-guided marking for localization of pulmonary nodules

当院のCTガイド下マーキングの有効性と安全性を調べる為，術前マーキングを実施した267病変の患者背景，合併症を後方視的に解析した．223病変にナイロン糸付き金属マーカー（VATSマーカー）留置，44病変に色素法（インジゴカルミン）によるマーキングが行われた．マーキング完遂率は98.5％，成功率は99.3％であった．合併症は気胸110例（41.2％），肺内出血76病変（28.5%），マーカー脱落14病変（マーカー留置の6.3％），空気塞栓1例（0.37％）であった．マーキング手技別に二群に分けた検討ではVATSマーカー留置群で気胸が有意に多かった．気胸と肺内出血を評価項目とした場合，1）年齢，2）穿刺ルートにおける臓側胸膜から腫瘍までの距離，3）マーキング手技の3項目が予測因子であった．肺実質への穿刺を伴うCTガイド下マーキングにおいては合併症に留意し，適切な症例・手技選択が必要である．

Optionen zur präoperativen Markierung

In dermatosurgery, alarge number of operations involve nonsterile preoperative marking and sterile intraoperative marking to define the surgical area. This includes marking of veins and sentinel lymph nodes as well as marking of borders of malignant or benign tumors. Ideally, the markings should be resistant to disinfectant without leaving apermanent tattoo on the skin. For this purpose, avariety of commercial and noncommercial, pre- as well as intraoperative color marking options are available, such as surgical color marking pens, xanthene dyes, autologous patient blood, or permanent markers. The permanent pen is suitable for preoperative marking. It is inexpensive and can be reused. Nonsterile surgical marking pens can also be used for this purpose, but they are more expensive to purchase. Patient blood, sterile surgical marking pens, and eosin are suitable for intraoperative marking. Eosin is inexpensive and has many advantages, such as good skin compatibility. The marking options presented are good alternatives to the use of expensive colored marking pens.

Minimizing invasiveness and simplifying the surgical procedure for upper and middle early gastric cancer with near-infrared light and organ traction

BackgroundSurgeons are often faced with optimal resection extent and reconstructive method problems in laparoscopic gastrectomy for gastric cancer in the upper and middle body of the stomach. Indocyanine green (ICG) marking and Billroth I (B-I) reconstruction were used to solve these problems with the organ retraction technique.Case presentationA 51-year-old man with upper gastrointestinal endoscopy revealed a 0-IIc lesion in the posterior wall of the upper and middle gastric body 4 cm from the esophagogastric junction. Clinical T1bN0M0 (clinical stage IA) was the preoperative diagnosis. Laparoscopic distal gastrectomy (LDG) and D1 + lymphadenectomy was decided to be performed considering postoperative gastric function preservation. The ICG fluorescence method was used to determine the accurate tumor location since the determination was expected to be difficult to the extent of optimal resection with intraoperative findings. By mobilizing and rotating the stomach, the tumor in the posterior wall was fixed in the lesser curvature, and as large a residual stomach as possible was secured in gastrectomy. Finally, delta anastomosis was performed after increasing gastric and duodenal mobility sufficiently. Operation time was 234 min and intraoperative blood loss was 5 ml. The patient was allowed to be discharged on postoperative day 6 without complications.ConclusionThe indication for LDG and B-I reconstruction can be expanded to cases where laparoscopic total gastrectomy or LDG and Roux-en-Y reconstruction has been selected for early-stage gastric cancer in the upper gastric body by combining preoperative ICG markings and gastric rotation method dissection.

Surgical disconnection of high delineated immature debilitating jejunal fistulas using posterolateral access

Objective. The aim of the study was to develop the safest technique for surgical disconnection of high, unformed jejunal fistulas, so as to avoid problems with detection the intestine leading to the fistula and to avoid complications of viscerolysis. Material and methods. The authors present their experience in surgical management of 35 patients with high delimited unformed debilitating jejunal fistulas. Of these, 22 patients were included in the comparison group; their fistulas were closed or disconnected with the known methods. Findings obtained from other 172 patients with adhesive intestinal obstruction after infectious complications of laparotomic wounds and topography of visceroparietal planar adhesions of the peritoneum were analyzed. After studying the nature and location of visceroparietal adhesions, the authors could develop a technique for proximal disconnection of high delimited unformed debilitating jejunal fistulas using posterolateral access which was applied in 13 patients from the studied group. Research results. The proposed technique of unilateral disconnection of high unformed jejunal fistulas reduces duration, damage and risk of prolonged bowel deserosing. As a result, a significant decrease in postoperative mortality from 59.1 ± 9.2% to 23.1 ± 11.2% (t=2.5; p&lt;0.05) was registered. Due to the preoperative endoscopic marking showing direction to the fistula of intestinal loop and duodenojejunal junction, intraoperative orientation was more accurate and took much less time than in the comparison group. The posterolateral surgical approach to the fistula in the jejunal loop reduced the risk of its damage, since there was no need for extensive enterolysis anymore. Therefore, postoperative period in patients of the studied group was better and with fewer complications than in the comparison group. Conclusion. The posterolateral access prevented extended viscerolysis and allowed to put a reliable and atraumatic interintestinal anastomosis so as to disconnect the fistula. The unilateral disconnection of the jejunal fistula at postoperative intestinal paresis unloaded the interintestinal anastomosis, similar to Meidl’s definitive jejunostomy. The abovementioned positive aspects of the proposed surgical intervention allowed to significantly decrease postoperative complications and mortality rate, if to compare with outcomes after known surgical interventions with a similar purpose.

Cultural Adaptation and Validation of the Ostomy Skin Tool to the Brazilian Portuguese.

To adapt the Ostomy Skin Tool (discoloration, erosion, and tissue overgrowth) to the Brazilian culture and to analyze psychometric properties of the adapted version. Psychometric (methodologic) evaluation of the instrument. Three ostomy/enterostomal therapy nurses evaluated the extent and severity of peristomal skin conditions in a sample of 109 adults 18 years or older with peristomal skin complications. These participants were receiving care in an ambulatory care center in outpatient health services in Sao Paulo and Curitiba, Brazil. In addition, interobserver reliability was measured using a group of 129 nurse participants who attended the Brazilian Congress of Stomatherapy held from November 12 to 15, 2017, in Belo Horizonte, a city located in the state of Minas Gerais, Brazil. Nurse participants assessed the descriptions of peristomal skin complications of the Portuguese version, using the same photographs used in the original DET score, purposely placed out of original order. The study was performed in 2 stages. The instrument was translated into Brazilian Portuguese by 2 bilingual translators, and back-translated into English. The back-translated version was sent to one of the developers of the instrument for additional evaluation. During stage 2, content validity was evaluated by 7 nurses with expertise in ostomy and peristomal skin care. Convergent validity was evaluated by correlating the severity of peristomal skin complications to pain intensity. Discriminant validity was evaluated based on type and time of ostomy creation, presence of retraction, and preoperative stoma site marking. Finally, interrater reliability was evaluated using standardized photograph evaluation reproduced in the same sequence as the original English language version of the instrument, along with paired scores from assessment of adults living with an ostomy generated by an investigator and nurse data collectors. The Content Validity Index for the Ostomy Skin Tool was 0.83. Levels of mild agreements were obtained for the nurses' observations in the evaluation of peristomal skin complications using standardized photographs (κ= 0.314). In contrast, moderate to almost perfect agreements were obtained when scores were compared in the clinical setting (κ= 0.48-0.93, according to the domains). Positive correlations between the instrument and pain intensity (r = 0.44; P = .001) indicate convergent validity of the adapted version of the Ostomy Skin Tool. In contrast, analysis of discriminant validity was mixed and definitive conclusions about this form of construct validity cannot be made based on this study. This study supports convergent validity and interrater reliability of the adapted version of the Ostomy Skin Tool.

Abstract P2-14-01: MOLECULAR FLUORESCENCE-GUIDED SURGERY USING BEVA800 FOR THE ASSESSMENT OF TUMOR MARGINS DURING BREAST CONSERVING SURGERY OF PATIENTS WITH PRIMARY BREAST CANCER (MARGIN-II)

Abstract Introduction: The goal of breast conserving surgery (BCS) for early breast cancer (EBC) is to remove the tumor in toto and preserving as much of the normal breast tissue as possible. In 20-50% of cases a re-excision is necessary because of involved margins. Repeat surgeries are not only a burden to patients physically but also psychologically and can delay recommended adjuvant therapies. Accurate determination of tumor margins during surgery is therefore a critical need. Breast cancer tissue produces significantly higher amounts of VEGF-A than healthy tissue. VEGF-A stimulates tumor angiogenesis and is therefore a target for molecular imaging techniques. The fluorescence imaging agent bevacizumab-IRDye800CW (Beva800) is a conjugate of bevacizumab and IRDye800CW and binds specifically to VEGF-A. Beva800 provides a potentially efficacious approach to imaging specimen and cavity margins during BCS. We are presenting a phase II study that combined Beva800 with the SurgVision Explorer Air camera for intraoperative margin assessment during BCS for EBC. Methods: MARGIN II is a multicenter open-label single arm prospective clinical trial aimed at evaluating Beva800 for assessment of tumor margins in women with EBC scheduled for BCS. The study was a within-patient comparison of positive tumor margin rates using BCS standard of care margin assessment compared to intraoperative assessment with 4.5 mg Beva800 and fluorescence imaging with the SurgVision Explorer Air camera. All patients received an i.-v. bolus injection of 4.5 mg of Beva800 three days before surgery. The fluorescent signal was visualized during surgery using NIR fluorescence imaging (700–1000 nm). Standard of care margin assessment was defined as visual inspection, palpation and, in cases of pre-operative wire marking, specimen sonography or mammography. Beva800 efficacy was determined as the number of patients in which a pathology-confirmed positive margin was identified by fluorescence-guided surgery using Beva800 but not by standard of care BCS. Results: 49 patients were included in 5 centers. 4 training cases were only included in the safety analysis, 45 patients were evaluable for the efficacy analysis. 8 patients (17.8%) had involved margins after standard of care BCS, 4 of which were detected by molecular fluorescence intraoperatively resulting in the reduction of patients with positive margins by 50% (95% CI: 15.7%, 84.3%). 4 patients (8.9%; 95% CI: 2.5%, 21.1%) needed a re-excision because of involved margins. In 27 patients (60.0%) the additional molecular fluorescence guided cavity shaving did not change the resection status from positive to negative (false positive). Adverse events were reported by 16 of 49 patients (32.7%), but only 3 (6.1%) were related to Beva800 (syncope, hot flush, hypertensive crisis). One patient experienced a treatment related SAE (hypertensive crisis). No anti-Beva800 antibodies were detected. Conclusion: In our analysis the rate of necessary second operations was reduced by 50% using Beva800 and the SurgVision Explorer Air camera. The safety analysis confirmed the positive safety profile of Beva800 found in previous studies. Molecular fluorescence-guided surgery may have the potential to change the practice of breast conserving surgery by reducing unnecessary re-excisions. Future studies will have to address the high false positive rates. Citation Format: Hans-Christian Kolberg, Carmen Röhm, Angrit Stachs, Florian Schütz, Jens-Uwe Blohmer, Sarah Wetzig, Steffi Hartmann, Jörg Heil, Markus Hahn. MOLECULAR FLUORESCENCE-GUIDED SURGERY USING BEVA800 FOR THE ASSESSMENT OF TUMOR MARGINS DURING BREAST CONSERVING SURGERY OF PATIENTS WITH PRIMARY BREAST CANCER (MARGIN-II) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-14-01.

Reply to the Letter to the Editor Regarding the Article: Augmented Reality Device for Preoperative Marking of Spine Surgery Can Improve the Accuracy of Level Identification.

Reply to the Letter to the Editor Regarding the Article: Augmented Reality Device for Preoperative Marking of Spine Surgery Can Improve the Accuracy of Level Identification.