Multicenter Prospective Randomized Research Articles

OP16 Postoperative endoscopic recurrence after ileocecal resection for Crohn’s disease with Kono-S or side-to-side functional end anastomosis:12-18 months follow-up results from a Multicenter Prospective Randomized Trial

Abstract Background Previous studies have suggested that a novel anastomosis (Kono-S) is associated with lower endoscopic and surgical recurrence rates after ileocecal resection for Crohn’s disease (CD)[1-3]. This study aims to compare the endoscopic recurrence between the Kono-S and side-to-side functional end anastomosis at 12-18 months after ileocecal resection for CD. Methods Prospective randomized trial conducted at 8 international centers. Patients undergoing ileocecal resection were randomized to a Kono-S(Group 1) or a side-to-side functional end (Group 2) anastomosis and were discharged on no biologicals. Exclusion criteria included age (<18), pregnancy, recurrent or multisite CD, and need of postoperative treatment with biologicals. Data were collected prior to and during surgery, daily after surgery until discharge, at 30 days post-op, and during colonoscopy at 12-18 months(m). Biologic therapy was allowed after the first colonoscopy at 3-6 m. Participating surgeons were instructed in the Kono-S technique through videos. Disease clinical activity was measured by the Harvey-Bradshaw Index (HBI). Endoscopic remission/recurrence was graded with the modified Rutgeerts score, and all sites used the same endoscopic evaluation protocol (Image1). Endoscopic remission was defined as a Rutgeerts score of 0,1 or 2a, and a Rutgeerts score of 2b or higher was considered a recurrence. All study sites had Institutional Review Board approval, ClinicalTrial.gov #NCT03256240. Results We enrolled 366 CD patients (50.0% female) with a median age of 35(18-81). 192 patients were randomized to Group 1(Kono-S) and 174 to Group 2(Side-to-Side). 255 patients (70%) completed 12-18m follow-up. Group 1 had a higher incidence of past smokers (87 vs.54, p=0.005) and current smokers (56 vs.27, p=0.002). 216(59%) patients underwent 12-18m colonoscopy, and 70/216(32.4%) had endoscopic recurrence (36/114,31.6% in Group 1 and 34/102,33.3% in Group 2, p=0.884). 106/216(49.1%) had been started on biological therapy after the first colonoscopy at 3-6 months. Subgroup analyses for endoscopic recurrence at 12-18m showed no significant difference between the groups (with biologicals p=0.539; without biologicals p=0.684). There was no difference in recurrence rate based on biologicals irrespective of anastomosis type. Stricturing (B2), fistulating disease (B3), and HBI moderate disease activity before surgery were predictive for 12-18m endoscopic recurrence with odds respectively of OR=4.20,[1.19-19.46], p=0.028, OR=5.35,[1.45-19.69], p=0.012, and OR=3.29,[1.26-8.60], p=0.015. Conclusion Kono-S and Side-to-Side anastomoses have similar endoscopic recurrence rates at 12-18 months. CD type and clinical disease activity are predictors of recurrence.

TCT-486 Ultrasound-Based Renal Denervation Reduces Blood Pressure in Patients With Chronic Kidney Disease: Results of a Multicenter Prospective Randomized Sham-Controlled Blinded Investigator Initiated Trial

TCT-486 Ultrasound-Based Renal Denervation Reduces Blood Pressure in Patients With Chronic Kidney Disease: Results of a Multicenter Prospective Randomized Sham-Controlled Blinded Investigator Initiated Trial

Comparison of exsanguination and hemostasis devices for Limb surgery: a multicenter randomized controlled study

BackgroundExcessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage).MethodsThis randomized controlled trial evaluates the exsanguination tourniquet ring’s effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators.ResultsThe experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p-value = 0.442; for the per protocol set, p-value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p-value = 0.502; for the per protocol set, p-value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group (p-value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups (p-value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device.ConclusionsThe exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries.Trial registrationComparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023.

Are Two Gliflozins Different: A Prospective Multicenter Randomized Study to Assess Effect of Remogliflozin Compared With Empagliflozin on Biomarkers of Heart Failure in Indian Patients With Type 2 Diabetes Mellitus with Chronic Heart Failure (REMIT-HF Study)

BackgroundThere is limited data comparing two gliflozins on their effect on biomarkers in diabetic patients with chronic heart failure. MethodsA prospective, multicenter, active controlled, double-arm, investigator-initiated, interventional study enrolled 250 adults with T2DM and comorbid CHF (LVEF<40%; NT-proBNP >600pg/ml). 125 patients were allocated each to Remogliflozin (R) and Empagliflozin (E) group and followed up for 24 weeks. The primary endpoint was the mean percentage change from baseline in NT-proBNP level after 24 weeks. ResultsThere was significant improvement from baseline in mean NT-proBNP level in both groups after 24 weeks however there was no significant difference between the two groups (p= 0.214). The mean NT-proBNP level improved from 2078.15±1764.70 pg/ml at baseline to 1185.06±1164.21 pg/ml at 6 months in R-group (p≤0.001) and from 2283.98±1759.15 pg/ml at baseline to 1395.33±1304.18 pg/ml at 6 months in E-group (p= <0.001). Left ventricular ejection fraction (LVEF) and LV volumes improved in both the groups. The glycemic parameters (HbA1c, FPG and PPG) demonstrated a significant reduction from baseline to week 24 in both groups. Similar improvement was seen in heart rate, blood pressure and weight reduction over 6 months in both groups. There was no drug related serious adverse event in any group. ConclusionRemogliflozin and Empagliflozin significantly improves glycemic parameters and NT-proBNP levels as the index of the therapeutic effects in T2DM patients with CHF. The positive effects are comparable in both groups.

A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria: The Safe Testing of Risk for Asymptomatic Microhematuria Trial.

AUA guidelines for patients with microhematuria (≥3 red blood cells [RBC]/high-power field [hpf]) include cystoscopy for most over age 40 due to risk of urothelial cancer (UC). Cxbladder Triage (CxbT) is a urinary genomic test with UC negative predictive value of 99%. In this prospective randomized controlled trial, we compared cystoscopy use in a standard of care (SOC) arm vs a marker-based approach. All patients with hematuria provided urine for a CxbT. Those categorized as lower risk (LR), defined as 3 to 29 RBC/hpf and minimal smoking history (<10 pack-years) were randomized between the test group provided with the CxbT result vs the SOC control group. Negative CxbT patients were offered omission of cystoscopy with surveillance. "Not lower risk" (NLR) patients (>30 RBC/hpf or >10 pack-year smoking history) had a CxbT but otherwise SOC. Patient decision and outcomes were recorded. Of 390 eligible patients, 255 were NLR and 135 were LR randomized to CxbT informed decision or SOC. The median age was 62 years (range 18-94) and 54% were male. Overall, 63% of CxbT tests were negative. For NLR patients, 82% had cystoscopy. In the LR control group, cystoscopy was performed in 67% of SOC and 27% in the test group (relative risk 0.41 [95% CI 0.27-0.61]). Compared to cystoscopy, CxbT had 90% sensitivity, 56% specificity, and 99% negative predictive value for UC. In this prospective randomized controlled trial, use of CxbT in patients with LR hematuria resulted in 59% reduction of cystoscopy use. This clinical utility of CxbT can reduce the burden of unnecessary cystoscopies.

Multicenter prospective randomized controlled clinical trial comparing the pocket-creation method with and without single-clip traction of colonic endoscopic submucosal dissection.

The pocket-creation method (PCM) was developed to overcome the technical difficulties of endoscopic submucosal dissection (ESD), although opening the pocket remains challenging. We developed a novel technique of PCM with single-clip traction (PCM-CT), which uses a reopenable clip as a traction device to maintain stability during the procedure. No prospective study has compared the efficacy of PCM-CT and PCM. This study aimed to investigate the effectiveness of PCM-CT vs. PCM in a randomized controlled trial. This randomized controlled clinical trial was conducted at four Japanese institutions. Patients with superficial colorectal neoplastic lesions were included following Japanese guidelines for colorectal cancer. Seven moderately experienced endoscopists performed the ESD procedures using either PCM-CT or PCM. 100 patients were enrolled in the study. Compared with PCM, PCM-CT achieved significantly faster mean (SD) dissection speed (21.4 [10.8] vs. 27.0 [14.5] mm2/min [95%CI 0.5 to 10.7], P = 0.03), and reduced the mean procedure time (81.8 [57.9] vs. 64.8 [47.6] minutes [95%CI -38.2 to 4.3], P = 0.12) and pocket-opening time (37.8 [33.0] vs. 30.0 [28.9] minutes [95%CI -20.2 to 4.6], P = 0.22). En bloc and R0 resection rates were not significantly different between the two groups (100% vs. 100%, P >0.99; 100% vs. 96%, P = 0.50, respectively). No significant differences were observed in adverse events between the two groups. ESD facilitated by the novel PCM-CT method appeared to be significantly faster than PCM. Both methods achieved high R0 resection rates.

Patient-Controlled Subcutaneous Analgesia with Hydromorphone versus Oral Oxycontin for Opioid Titration of Cancer Pain: A Prospective Multicenter Randomized Trial.

Studies have shown that oral oxycontin tablets can be used for opioid titration. The European Society for Medical Oncology (ESMO) guidelines for adult cancer pain recommend opioid titration through the parenteral route, usually the intravenous or subcutaneous route. Patient-controlled subcutaneous analgesia (PCSA) with hydromorphone needs further evaluation for opioid titration. This prospective multicenter study was designed to compare the efficacy and safety of hydromorphone PCSA with oral oxycontin tablets for opioid titration of cancer pain. Eligible patients with cancer pain were randomly assigned in a 1:1 ratio to the PCSA group or the oxycontin group for dose titration. Different titration methods were given in both groups depending on whether the patient had an opioid tolerance. The primary endpoint of this study was time to successful titration (TST). A total of 256 patients completed this study. The PCSA group had a significantly lower TST compared with the oxycontin group (median [95% confidence interval (CI)], 5.5[95% CI:2.5-11.5] hours vs.16.0 [95% CI:11.5-22.5] hours; p<0.001). The frequency (median; interquartile) of breakthrough pain (Btp) over 24 hours was significantly lower in the PCSA group (2.5;2.0-3.5) than in the oxycontin group.(3.0; 2.5-4.5) (p=0.04). The pain was evaluated by numeric rating scale (NRS) score at 12 hours after the start of titration. The pain score (median; interquartile) was significantly lower in the PCSA versus the oxycontin group (2.5;1.5-3.0) vs 4.5;3.0-6.0) (p=0.02). The equivalent dose of oral morphine (EDOM) for a successful titration was similar in both groups (p=0.29), but there was a significant improvement in quality of life (QoL) in both groups (p=0.03). No between-group difference in the incidence of opioid-related adverse effects was observed (p=0.32). Compared with oral oxycontin tablet, the use of PCSA with hydromorphone achieved a shorter titration duration for patients with cancer pain (p<0.001), without significantly increasing adverse events (p=0.32).

GCISAVE: A non-comparative randomized phase II study of combination of gemcitabine cisplatin (GCis) +/- avelumab (A) in 1st line treatment for locally advanced or metastatic urothelial bladder carcinoma (MUBC)—GETUG AFU V07.

GCISAVE: A non-comparative randomized phase II study of combination of gemcitabine cisplatin (GCis) +/- avelumab (A) in 1st line treatment for locally advanced or metastatic urothelial bladder carcinoma (MUBC)—GETUG AFU V07.

OP20 Postoperative endoscopic recurrence after resection of Crohn’s terminal ileitis with Kono-S or side-to-side functional end anastomosis: results of a Multicenter Prospective Randomized Trial

Abstract Background A novel anastomosis (Kono-S) was described in 2003 in Crohn’s disease. Subsequent observations have suggested that this anastomosis is associated with lower endoscopic and surgical recurrence rates. The purpose of this study was to compare the endoscopic recurrence between the Kono-S and the side-to-side functional end anastomosis at 3-6 months after resection of Crohn’s terminal ileitis. Methods This was a prospective multi-center randomized trial conducted at eight international centers. Patients with Crohn’s terminal ileitis requiring elective ileocecal resection were randomized to a Kono-S (Group1) or a side-to-side functional end (Group2) anastomosis (Image1). Patients were discharged on no biologicals. Exclusion criteria included age (&amp;lt;18), pregnancy, recurrent or multisite Crohn’s disease, and need of postoperative treatment with biologicals. Data were collected prior to and during surgery, daily after surgery until discharge, at 30 days post-op, and at 3-6 months colonoscopy. Participating surgeons were instructed in the Kono-S technique through videos. Disease clinical activity was measured by Harvey Bradshaw Index (HBI). Endoscopic remission/recurrence was graded with the modified Rutgeerts score: endoscopic remission was defined as a Rutgeerts score of 0, 1, or 2a, and a Rutgeerts score of 2b or higher was considered a recurrence. All study sites had Institutional Review Board approval, ClinicalTrial.gov # NCT03256240. Results We enrolled 288 Crohn’s patients (50.7% female) with a median age of 34 (18-81). 154 patients were randomized to Group 1 (Kono-S) and 134 to Group 2 (Side-to-Side). 30 days follow-up was completed on 278 (96.9%) patients. The Kono-S group had a higher percentage of past smokers (57 vs.30, p = 0.007) and current smokers (33 vs.12, p = 0.004). The mean operative time was 22 minutes longer in the Kono-S group (154 vs.132 minutes; p = 0.386). There was no mortality. 233 (81%) patients underwent a colonoscopy at 3-6 months. There was no significant difference between the two groups in terms of endoscopic recurrence (p = 0.883) and HBI (p = 0.109) or in recurrence-free survival (Log Rank Mantel-Cox test p = 0.256) (Table 1). On multivariable analysis, current smokers had significantly higher odds for endoscopic recurrence at 3-6 months (OR= 2.80, [95% CI =1.10 - 6.92], p = 0.029). Conclusion Kono-S and Side-to-side anastomoses have similar endoscopic recurrence rates at 3-6 months. Independently of surgical techniques, smokers had a significantly higher rate of endoscopic recurrence at 3-6 months after surgery.

A Multicenter Prospective Randomized Controlled Study of a New Corneal Wetting Agent During Ophthalmologic Surgery.

A multicenter prospective randomized controlled study was used to investigate the effect and safety of a new corneal wetting agent called the Corneal Surface Viscoelastic Protector (CsVisc, Success Bio-Tech Co., Ltd, China), on the corneal epithelium during ophthalmic surgery by comparison with the commercially available Cornea Protect (CP, Valeant Med Sp. zo. o. Leobendorf, Austria). This multicenter prospective randomized controlled study comprised patients scheduled for cataract surgery and pars plana vitrectomy. The patients were randomly assigned to receive either a new corneal wetting agent (CsVisc) or Cornea Protect (CP, Valeant Med Sp. zo. o. Leobendorf, Austria). Optical clarity during surgery, application frequency, duration of effect, diffusion time of corneal wetting agents, fluorescein staining, intraocular pressure (IOP), tear-film break-up time (TBUT), and Schirmer I test (SIT) were assessed. Adverse events were noted on the designated patient case report forms. A total of 149 eyes (149 patients, mean age 62years; range 25-80years) were included in the study. There were 74 eyes in the control group and 75 eyes in the study group. In patients who underwent vitrectomy, the frequency of application was 1.62 ± 1.03 in the study group and 1.39 ± 0.66 in the control group, with no significant difference (P = 0.399), and the duration of effect was 19.16 ± 6.94min in the study group and 19.06 ± 7.22min in the control group, with no significant difference (P = 0.835). The optical clarity of the study group was not significantly different from that of the control group (P = 0.485). In patients who underwent cataract surgery, the frequency of application was 1.10 ± 0.38 in the study group and 1.07 ± 0.26 in the control group, and the difference was not significant (P = 0.950). The difference between the duration of effect in the study group (8.32 ± 2.50min) and the control group (7.63 ± 2.52min) was not significant (P = 0.310). The difference in optical clarity scores between the two groups was not statistically significant (P = 0.600). Among all patients in this study, the diffusion time of the corneal wetting agent was 14.97 ± 10.07s in the control group and 11.23 ± 8.41s in the study group, with a statistically significant difference (p = 0.008). The frequency of adverse events was 20.00% (15/75) in the study group and 14.86% (11/74) in the control group, with no statistically significant difference (P = 0.409). There were no serious adverse events related to the test medical device or causing patients to withdraw from the study. The CsVisc is safe and effective in preventing intraoperative corneal epithelial damage due to corneal dryness and can be comparable to the CP. In addition, the CsVisc has a shorter diffusion time.

Prospective Multicenter Randomized Controlled Trial of Surgical Versus Nonsurgical Treatment for Acute Rockwood Type 3 Acromioclavicular Injury.

Evidence for the superiority of surgical versus nonsurgical treatment of Rockwood type 3 acromioclavicular joint (ACJ) dislocation is still lacking. It was hypothesized that surgical treatment will outperform nonsurgical treatment. Randomized controlled trial; Level of evidence, 1. A prospective randomized trial involving 4 study centers was performed from January 1, 2011, to March 31, 2016. A total of 85 patients with acute Rockwood type 3 ACJ dislocations were allocated randomly to receive either nonsurgical or surgical treatment. A total of 70 patients were treated as allocated, and 8 patients made an early crossover from nonsurgical to surgical treatment, leaving 47 patients treated surgically and 31 patients nonsurgically. All patients were followed up longitudinally, including clinical evaluation using the Constant score and standardized radiographic evaluation, with final follow-up after 2 years. At no follow-up time point was there a significant difference in Constant score between the surgically and nonsurgically treated patients. Radiographic analysis showed not only an inferior coracoclavicular distance at all follow-up points for surgical treatment but also a higher incidence of posttraumatic osteoarthritis and heterotopic ossifications, without any negative clinical correlation. With regard to complications, 1 patient (3%) in the nonsurgical group underwent secondary surgical ACJ stabilization. The revision rate after surgical treatment was 17% (P < .001). Neither primary horizontal instability nor younger age were associated with inferior clinical outcomes after nonsurgical treatment. Surgical treatment of ACJ Rockwood type 3 injuries did not lead to superior functional outcomes. Neither younger age nor horizontal instability were associated with inferior outcomes after nonsurgical treatment. Surgical treatment led to a slower recovery and to higher complication and revision rates. ISRCTN registry (study ID: ISRCTN92265154).

Influence of opioid analgesia type on circulating tumor cells in open colorectal cancer surgery (POACC-1): study protocol for a prospective randomized multicenter controlled trial

BackgroundOpioids and epidural analgesia are a mainstay of perioperative analgesia but their influence on cancer recurrence remains unclear. Based on retrospective data, we found that cancer recurrence following colorectal cancer surgery correlates with the number of circulating tumor cells (CTCs) in the early postoperative period. Also, morphine- but not piritramide-based postoperative analgesia increases the presence of CTCs and shortens cancer-specific survival. The influence of epidural analgesia on CTCs has not been studied yet.MethodsWe intend to enroll 120 patients in four centers in this prospective randomized controlled trial. The study protocol has been approved by Ethics Committees in all participating centers. Patients undergoing radical open colorectal cancer surgery are randomized into epidural, morphine, and piritramide groups for perioperative analgesia. The primary outcome is the difference in the number of CTCs in the peripheral blood before surgery, on the second postoperative day, and 2–4 weeks after surgery. The number of CTCs is measured using molecular biology methods. Perioperative care is standardized, and relevant data is recorded. A secondary outcome, if feasible, would be the expression and activity of various receptor subtypes in cancer tissue. We intend to perform a 5-year follow-up with regard to metastasis development.DiscussionThe mode of perioperative analgesia favorably affecting cancer recurrence would decrease morbidity/mortality. To identify such techniques, trials with long-term follow-up periods seem suboptimal. Given complex oncological therapeutic strategies, such trials likely disable the separation of perioperative analgesia effects from other factors. We believe that early postoperative CTCs presence/dynamics may serve as a sensitive marker of various perioperative interventions´ influences on cancer recurrence. Importantly, it is unbiased to the influence of long-term factors and minimally invasive. Analysis of opioid/cannabinoid receptor subtypes in cancer tissue would improve understanding of underlying mechanisms and promote personalization of treatment. We are not aware of any similar ongoing studies.Trial registration numberNCT03700411, registration date: October 3, 2018. Study status: recruiting.

Effects of Aerobic Exercise in the Intensive Care Unit on Patient-Reported Physical Function and Mental Health Outcomes in Severely Burned Children-A Multicenter Prospective Randomized Trial.

Forty-eight children between the ages of seven and seventeen with ≥30% total body surface area (TBSA) burn were randomized in a 1:2 fashion to receive treatment with standard-of-care (SOC) or standard-of-care plus exercise (SOC+Ex). Surveys administered at admission and discharge collected patient-reported information regarding physical and mental health outcomes. The results are given as means +/- standard deviation. Significance was set at p < 0.05. The average age of the SOC and SOC+Ex groups were 12 ± 3 and 13 ± 4 years, respectively. The average %TBSA burned in the SOC and SOC+Ex groups were 54 ± 17 and 48 ± 14, respectively. The SOC+Ex group averaged 10 ± 9 exercise sessions (range of 1 to 38 sessions) with an attendance rate of 25% (10 sessions out of 40 BICU days). Both groups demonstrated significant improvement in patient-reported physical and mental outcomes during hospital admission (p < 0.05) However, additional exercise did not exhibit any additional benefits for measured levels. Our recommendation is for all pediatric patients in the BICU to continue with the SOC and consult with their physician over the benefits of additional aerobic exercise. This study suggests that perhaps there is potential for increasing the amount of exercise that can be administered to pediatric burn survivors beyond SOC as we did not find aerobic exercise to be of any harm to any patients if it is performed properly and under supervision.

A Prospective Multicenter Randomized Controlled Trial to Evaluate the Efficacy of Chitosan Hydrogel Paste in Comparison to Commercial Hydroactive Gel as a Wound Bed Preparation.

Background This clinical trial aimed to evaluate the clinical efficacy of chitosan derivative hydrogel paste (CDHP) as a wound bed preparation for wounds with cavities. Methods This study enrolled 287 patients, with 143 patients randomized into the CDHP group (treatment) and 144 patients randomized into the commercial hydroactive gel (CHG) group (control). The granulation tissue, necrotic tissue, patient comfort, clinical signs, symptoms, and patient convenience during the application and removal of the dressing were assessed. Results The study was completed by 111 and 105 patients from the treatment and control groups, respectively. Both groups showed an increasing mean percentage of wound granulation over time when the initial wound size and comorbidity were adjusted (F(10,198) = 4.61; p < 0.001), but no significant difference was found between the groups (F(1,207) = 0.043; p = 0.953). The adjusted mean percentage of necrotic tissue of both groups showed a significant decrease over time (F(10,235) = 5.65; p <0.001), but no significant differences were found between the groups (F (1,244) = 0.487; p = 0.486). Conclusion CDHP is equivalent to CHG and is an alternative in wound management and wound bed preparation for wounds with cavities.

Artificial Intelligence Solution for Chest Radiographs in Respiratory Outpatient Clinics: Multicenter Prospective Randomized Clinical Trial.

Rationale: Artificial intelligence (AI)-assisted diagnosis imparts high accuracy to chest radiography (CXR) interpretation; however, its benefit for nonradiologist physicians in detecting lung lesions on CXR remains unclear. Objectives: To investigate whether AI assistance improves the diagnostic performance of physicians for CXR interpretation and affects their clinical decisions in clinical practice. Methods: We randomly allocated eligible patients who visited an outpatient clinic to the intervention (with AI-assisted interpretation) and control (without AI-assisted interpretation) groups. Lung lesions on CXR were recorded by seven nonradiologists with or without AI assistance. The reference standard for lung lesions was established by three radiologists. The primary and secondary endpoints were the physicians' diagnostic accuracy and clinical decision, respectively. Results: Between October 2020 and May 2021, 162 and 161 patients were assigned to the intervention and control groups, respectively. The area under the receiver operating characteristic curve was significantly larger in the intervention group than in the control group for the CXR level (0.840 [95% confidence interval (CI), 0.778-0.903] vs. 0.718 [95% CI, 0.640-0.796]; P = 0.017) and lung lesion level (0.800 [95% CI, 0.740-0.861] vs. 0.677 [95% CI, 0.605-0.750]; P = 0.011). The intervention group had higher sensitivity in terms of both CXR and lung lesion level and a lower false referral rate for the lung lesion level. AI-assisted CXR interpretation did not affect the physicians' clinical decisions. Conclusions: AI-assisted CXR interpretation improves the diagnostic performance of nonradiologist physicians in detecting abnormal lung findings. Clinical trial registered with Clinical Research Information Service of the Republic of Korea (KCT 0005466).

Evaluating the Safety and Efficacy of a Novel Polysaccharide Hemostatic System for Multidisciplinary Application: A Multicenter Prospective Randomized Controlled Trial

Introduction: Operative blood loss is associated with postoperative morbidity and mortality. Hemostatic agents are used as adjunctive methods for hemostasis during surgery and to prevent postoperative bleeding. We evaluated safety and efficacy of an investigational polysaccharide hemostatic (PH) device, compared with an FDA-approved control in clinical use comprising microporous polysaccharide hemospheres (MPH), to achieve hemostasis of bleeding surfaces during surgery. Methods: This prospective multicenter trial enrolled patients undergoing open elective cardiac, general, or urological operation. Patients were stratified by bleeding severity and therapeutic area, then randomized 1:1 to receive PH or MPH. Bleeding assessments occurred intraoperatively using a novel bleeding assessment methodology. Primary endpoint was non-inferiority as compared with control via effective hemostasis at 7 minutes. Patients were followed postoperatively, discharge, and 6-weeks. Survival was assessed in oncology patients at 24-months. Safety of PH vs MPH was determined by comparing relative incidence of adverse events. Results: Across 19 centers, 324 (161 PH, 163 MPH) patients were randomized; approximately half underwent general surgery, while 25% each underwent cardiac and urologic surgery. PH met the primary endpoint of hemostatic success at 7-minutes demonstrating efficacy of PH was non-inferior to MPH. No significant differences were found in adverse event rates or supplementary safety measures. Six deaths were reported through 6-week follow-up. There was no difference in survival at 2 years (76% (PH) vs 74% (MPH), p = 0.66) for patients undergoing cancer operation. Conclusion: Across 3 therapeutic areas, PH was noninferior to MPH at all hemostasis assessment time points. No safety concerns were identified.

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents: BIOFLOW V Final 5-Year Outcomes.

Randomized trials have demonstrated the superiority of ultrathin strut drug-eluting stents compared with alternative stent designs. Whether these differences persist over late-term follow-up is uncertain. This study sought to compare late-term (5-year) clinical outcomes among patients treated with ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81 µm) durable polymer everolimus-eluting stents (DP EES). BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international, 2:1 randomized trial comparing percutaneous coronary intervention with ultrathin strut BP SES versus thin strut DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Prespecified outcomes through 5 years were assessed. Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 5-year rates of TLF were 12.3% for BP SES and 15.3% for DP EES (P = 0.108). Revascularization with BP SES was associated with a significantly lower target vessel-related myocardial infarction (6.6% vs 10.3%, P = 0.015) and late/very late definite/probable stent thrombosis (0.3% vs 1.6%, P = 0.021). Ischemia-driven target lesion revascularization was numerically but not significantly lower with BP SES (5.9% vs 7.7%, P = 0.202). Cardiac death rates were 2.6% versus 1.9% (P=0.495) for BP SES and DP EES, respectively. In a large, randomized trial, TLF and the individual outcomes of cardiac death and target lesion revascularization at 5 years were similar among patients treated with BP SES versus DP EES. Both target vessel-related myocardial infarction and late/very late definite/probable stent thrombosis were significantly lower with BP SES. These results confirm the durability of safety and the effectiveness of percutaneous coronary intervention with ultrathin BP SES.

EP07.01-026 Primary Pulmonary Ewing'S Sarcoma: Post Hoc Analysis From Two International Multicenter Prospective Randomized Trials

Primary pulmonary sarcoma accounts for 1% of all pulmonary malignant tumors. Ewing's sarcoma (ES) is an aggressive cancer with an incidence of 1 per 1,000,000. It is most commonly diagnosed in the second decade of life. It usually derives from bony structures of the axial skeleton, pelvis and femur but can occur in every localization. Pulmonary ES is extremely rare with less than 40 cases reported mostly as case reports. Here we aimed to gain better understanding of primary pulmonary ES in describing patients treated within two international multicenter prospective randomized ES trials.

Bevacizumab in High-Risk Corneal Transplantation: A Pilot Multicenter Prospective Randomized Control Trial

To determine the efficacy of local (subconjunctival and topical) bevacizumab (Avastin) treatment in patients undergoing vascularized high-risk corneal transplantation. Pilot, prospective, randomized, double-blind, placebo-controlled clinical trial conducted at 5 clinical centers in the United States, India, and Brazil. Patients aged > 18 years undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft. Patients were randomized to receive subconjunctival bevacizumab (2.5 mg/0.1 ml) or placebo at the time of surgery, followed by topical bevacizumab (10 mg/ml) or topical placebo, administered 4 times per day for 4 weeks. The 52-week endothelial immune rejection rate. Ninety-two patients were randomized to receive bevacizumab (n= 48) or control (n= 44). The 52-week endothelial rejection rate was 10% in the bevacizumab group and 19% in the control group (P= 0.20). Post hoc, extended follow-up at the lead study site showed an endothelial rejection rate of 3% in the bevacizumab group and 38% in the control group (P= 0.003). Treatment with bevacizumab was found to have a hazard ratio of 0.15 (95% confidence interval, 0.03-0.65, P= 0.01) in a post hoc Cox regression analysis. In patients undergoing vascularized high-risk corneal transplantation, there was no statistically significant difference in the rate of endothelial rejection at 1 year in the bevacizumab treatment group compared with the control group. This study may have been underpowered to detect a difference between treatment groups, and taken together, our data suggest that, in the current trial design, bevacizumab has a positive but not (yet) significant effect on endothelial rejection.

Comparative Outcomes Occur After Superficial Medial Collateral Ligament Augmented Repair vs Reconstruction: A Prospective Multicenter Randomized Controlled Equivalence Trial

Background: Although previous studies have reported good short-term results for superficial medial collateral ligament (sMCL) reconstruction, whether an augmented MCL repair is clinically equivalent remains unclear. Purpose/Hypothesis: The purpose of this study was to compare clinical outcomes between randomized groups that underwent sMCL augmentation repair and sMCL autograft reconstruction. The hypothesis was that there would be no significant differences in objective or subjective outcomes between groups. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were prospectively enrolled between 2013 and 2019 from 3 centers. Grade III sMCL injuries were confirmed via stress radiography. Patients were randomized to anatomic sMCL reconstruction versus augmented repair with surgical treatment, determined after examination under anesthesia confirmed sMCL incompetence. Postoperative visits occurred at 6 weeks and 6 months for repeat evaluation, with repeat stress radiography at final follow-up. Patient-reported outcome measures were obtained pre- and postoperatively at 6 months, 1 year, and final follow-up. The primary outcome measure was side-to-side difference on valgus stress radiographs at a minimum follow-up of 1 year. The two 1-sided t test procedure was used to test clinical equivalence for side-to-side difference in valgus gapping, and the Mann-Whitney U test was used to compare postoperative patient-reported outcome measures between groups. Results: A total of 54 patients were prospectively enrolled into this study. Of these, 50 patients had 6-month stress radiograph data, while 40 had 1-year postoperative valgus stress radiograph data. The mean (SD) patient age was 38.0 years (14.2), and body mass index was 25.0 (3.6). Preoperative valgus stress radiographs demonstrated 3.74 mm (1.1 mm) of increased side-to-side gapping overall, while it was 4.10 mm (1.46 mm) in the MCL augmentation group and 3.42 mm (0.55 mm) in the MCL reconstruction group. Postoperative valgus stress radiographs at an average of 6 months were obtained in 50 patients after surgery, which showed 0.21 mm (0.81 mm) for the MCL augmentation group and 0.19 mm (0.67 mm) for the MCL reconstruction group (P = .940). At final follow-up (minimum 1 year), median (interquartile range) Lysholm scores were significantly higher in the reconstruction group (90 [83-99]) as compared with the repair group (80 [67-92]) (P = .031). Final International Knee Documentation Committee (IKDC) scores were also significantly higher for the reconstruction group (85 [68-89]) versus the repair group (72 [60-78] (P = .039). Postoperative Tegner scores were not significantly different between the repair group (5 [3.5-6]) and the reconstruction group (5.5 [4-7]) (P = .123). Patient satisfaction was also not significantly different between repair (7.5 [5.75-9.25]) and reconstruction groups (9.0 [7-10]) (P = .184). Conclusion: This study found no difference in objective outcomes between an sMCL augmentation repair and a complete sMCL reconstruction at 1 year postoperatively, indicating equivalence between these procedures. Patient-reported clinical outcomes favored the reconstruction over a repair. In addition, this study demonstrated that anatomic-based treatment of MCL tears with an early knee motion program had a very low risk of graft attenuation and a low risk of arthrofibrosis.