Prospective evaluation of transoral outlet reduction (TORe) after Roux-en-Y gastric bypass (RYGB) failure.

BACKGROUND AND AIMS: Weight regain after RYGB is multifactorial including dilatation of the gastro-jejunal anastomosis. Transoral outlet reduction (TORe) procedure is a minimally invasive alternative to surgical anastomotic revision. METHODS: We conducted a prospective, multicenter, simple blind, randomized study in patients with weight regain following RYGB, comparing the efficacy of conventional nutritional and behavioral management associated with a TORe procedure (TORe group) with conventional management alone and a Sham procedure (Sham group). The main objective of this study was to evaluate the percentage of excess weight loss (%EWL) at 12 months after endoscopy. RESULTS: From January 2015 to January 2019, 73 subjects were randomized in four French Bariatric centers. The final analysis involved 50 subjects, 25 in each group, 44 women, 6 men, with an average BMI of 40.6 kg/m2. At 12 months, the average %EWL was significantly higher in the TORe group than in the Sham group (13.5 ± 14.1 vs. - 0.77 ± 17.1; p = 0.002). Cohen's d was 0.91, indicating a large effect size of the procedure on the %EWL. There was no significant difference between groups concerning the improvement of obesity-related comorbidities (diabetes and dyslipidemia) and quality of life at 12 months. We report frequent adverse events in the TORe group (20% had adverse events related to the procedure). Three adverse events were serious, including two perforations of the gastro-jejunal anastomosis after TORe group that led to the premature termination of the study. CONCLUSIONS: After RYGBP failure linked to the dilatation of the gastro-jejunal anastomosis, TORe procedure with nutritional management results in significantly higher %EWL at 12 months compared to patients with nutritional management alone. As surgery, this minimally invasive endoscopic procedure can be associated with severe adverse events.

A Delphi Method for Development of a Barrett's Esophagus Question Prompt List as a Communication Tool for Optimal Patient-physician Communication.

BACKGROUND METHODS: The question prompt list content was derived through a modified Delphi process consisting of 3 rounds. In round 1, experts provided 5 answers to the prompts "What general questions should patients ask when given a new diagnosis of Barrett's esophagus" and "What questions do I not hear patients asking, but given my expertise, I believe they should be asking?" Questions were reviewed and categorized into themes. In round 2, experts rated questions on a 5-point Likert scale. In round 3, experts rerated questions modified or reduced after the previous rounds. Only questions rated as "essential" or "important" were included in Barrett's esophagus question prompt list (BE-QPL). To improve usability, questions were reduced to minimize redundancy and simplified to use language at an eighth-grade level (Fig. 1). RESULTS: Twenty-one esophageal medical and surgical experts participated in both rounds (91% males; median age 52 years). The expert panel comprised of 33% esophagologists, 24% foregut surgeons, and 24% advanced endoscopists, with a median of 15 years in clinical practice. Most (81%), worked in an academic tertiary referral hospital. In this 3-round Delphi technique, 220 questions were proposed in round 1, 122 (55.5%) were accepted into the BE-QPL and reduced down to 76 questions (round 2), and 67 questions (round 3). These 67 questions reached a Flesch Reading Ease of 68.8, interpreted as easily understood by 13 to 15 years olds. CONCLUSIONS: With multidisciplinary input, we have developed a physician-derived BE-QPL to optimize patient-physician communication. Future directions will seek patient feedback to distill the questions further to a smaller number and then assess their usability.

A Pilot Study of Percutaneous Cholecystoenteric Anastomosis: A New Option for High-Risk Patients with Symptomatic Gallstones.

PURPOSE: To evaluate the safety and effectiveness of percutaneous cholecystoenteric anastomosis (PCEA) creation in patients with indwelling cholecystostomy tubes who are high-risk surgical candidates. MATERIALS AND METHODS: Fourteen (male, 10; female, 4) patients with a mean age of 79 years (range, 53-92 years) with previously inserted cholecystostomy tubes underwent PCEA with the adjacent duodenum using a lumen-apposing metal stent (LAMS) between January 2015 and October 2022. Intraprocedural adverse events and postprocedural safety and effectiveness outcomes were evaluated. Nine procedures were performed under sedation and 5 under general anesthesia. RESULTS: Technical success was achieved in 100% of the patients. In 12 patients (86%), the existing cholecystostomy tube was removed after the insertion of the LAMS. Three patients (21%) had a pre-existing cholecystoduodenal fistula, in which the stent was placed, and 11 (79%) underwent creation of a de novo anastomosis. The mean procedure time was 1.5 hours (range, 1-2 hours). The mean length of stay after the procedure was 2.4 days (range, 1-10 days). There were no intraprocedural adverse events. One patient with severe pre-existing cardiac comorbidities died during his postprocedural stay despite a technically successful procedure. One patient had delayed closure of the long-standing cholecystocutaneous tract. CONCLUSIONS: Early clinical experience with PCEA using an LAMS suggests that it is a safe and effective option for the creation of internal gallbladder drainage in patients who are not candidates for surgical cholecystectomy.

Endoscopic ultrasound-guided perivascular pancreatic radiofrequency ablation using a hydroxyethyl starch solution prior to pancreatectomy.

Background and study aims Pancreatic surgery remains complex, particularly for borderline resectable and locally advanced tumors. Vascular invasion compromises resectability, and vascular resection entails increased morbidity and mortality. Following a feasibility and safety demonstration of augmented endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) using hydroxyethyl starch (HES) in porcine pancreatic parenchyma, the present study assesses whether this approach (EUS-sugar-RFA) in the pancreatic perivascular space is safe and creates a controllable margin of necrosis to enable a vessel-sparing resection. Methods EUS-sugar-RFA in the pancreatic parenchyma adjacent to the splenic artery and vein was performed in a live animal model. Following different survival periods (0-4 days) in the interventional group (n = 3), open pancreatectomy was carried out. The control group (n = 4) included open pancreatectomies in two pigs with non-treated pancreases and in two with pancreatic RFA alone on the same day. Results All procedures were completed successfully, without intraoperative or postoperative complications. Survival periods were uncomplicated. Histopathological examination showed local necrosis and inflammatory reaction at the ablation sites. Vascular wall integrity was preserved in all specimens. The untreated pancreatic zones in the interventional group were no different from the normal pancreases in the control group. Conclusions Preoperative perivascular augmented RFA using HES was safe, and in the pancreatic animal model, the best timeframe was within 24 hours before pancreatic surgery. This technique might improve resectability in selected borderline and locally advanced pancreatic cancers.

Development of a Preliminary Question Prompt List as a Communication Tool for Adults With Achalasia: A Modified Delphi Study.

BACKGROUND: Question prompt lists (QPLs) are structured sets of disease-specific questions that enhance patient-physician communication by encouraging patients to ask questions during consultations. AIM: The aim of this study was to develop a preliminary achalasia-specific QPL created by esophageal experts. METHODS: The QPL content was derived through a modified Delphi method consisting of 2 rounds. In round 1, experts provided 5 answers to the prompts "What general questions should patients ask when given a new diagnosis of achalasia" and "What questions do I not hear patients asking, but given my expertise, I believe they should be asking?" In round 2, experts rated questions on a 5-point Likert scale. Questions considered "essential" or "important" were accepted into the QPL. Feedback regarding the QPL was obtained in a pilot study wherein patients received the QPL before their consultation and completed surveys afterwards. RESULTS: Nineteen esophageal experts participated in both rounds. Of 148 questions from round 1, 124 (83.8%) were accepted into the QPL. These were further reduced to 56 questions to minimize redundancy. Questions were categorized into 6 themes: "What is achalasia," "Risks with achalasia," "Symptom management in achalasia," "Treatment of achalasia," "Risk of reflux after treatment," and "Follow-up after treatment." Nineteen patients participated in the pilot, most of whom agreed that the QPL was helpful (84.2%) and recommended its wider use (84.2%). CONCLUSIONS: This is the first QPL developed specifically for adults with achalasia. Although well-received in a small pilot, follow-up studies will incorporate additional patient feedback to further refine the QPL content and assess its usability, acceptability, and feasibility.

Endoscopic Ultrasound-guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis: A Prospective Multicenter Trial.

OBJECTIVE: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). BACKGROUND: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. METHODS: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). RESULTS: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. CONCLUSIONS: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.

Robotically assisted augmented reality system for identification of targeted lymph nodes in laparoscopic gynecological surgery: a first step toward the identification of sentinel node : Augmented reality in gynecological surgery.

BACKGROUND: To prove feasibility of multimodal and temporal fusion of laparoscopic images with preoperative computed tomography scans for a real-time in vivo-targeted lymph node (TLN) detection during minimally invasive pelvic lymphadenectomy and to validate and enable such guidance for safe and accurate sentinel lymph node dissection, including anatomical landmarks in an experimental model. METHODS: A measurement campaign determined the most accurate tracking system (UR5-Cobot versus NDI Polaris). The subsequent interventions on two pigs consisted of an identification of artificial TLN and anatomical landmarks without and with augmented reality (AR) assistance. The AR overlay on target structures was quantitatively evaluated. The clinical relevance of our system was assessed via a questionnaire completed by experienced and trainee surgeons. RESULTS: An AR-based robotic assistance system that performed real-time multimodal and temporal fusion of laparoscopic images with preoperative medical images was developed and tested. It enabled the detection of TLN and their surrounding anatomical structures during pelvic lymphadenectomy. Accuracy of the CT overlay was > 90%, with overflow rates < 6%. When comparing AR to direct vision, we found that scores were significatively higher in AR for all target structures. AR aided both experienced surgeons and trainees, whether it was for TLN, ureter, or vessel identification. CONCLUSION: This computer-assisted system was reliable, safe, and accurate, and the present achievements represent a first step toward a clinical study.

Development and validation of a novel porcine bile duct dilation model for EUS training.

Background and study aims Image-guided minimally invasive techniques have transformed the management of malignant and benign bile duct obstructions. These evolving techniques are being widely adopted and applied and hands-on training using high quality models is required to improve the proficiency of practitioners. This experimental study aimed to validate an in vivo porcine model created to simulate bile duct dilation for interventional endoscopic ultrasound (EUS) hands-on training curriculums. Materials and methods Thirty-six porcine models were involved and the procedures were performed in an experimental hybrid operating room under general anesthesia. Animals underwent endoscopic duodenal papilla clipping with several hemostatic metallic clips. After a survival period of 24 to 48 hours, the models with effective intrahepatic and extrahepatic bile duct dilatation were included in the hands-on training. Trainees and faculty were given structured evaluations of the model realism and usefulness. Results Extrahepatic bile duct and gallbladder dilation was achieved in all 36 of the models, and in 11 of the 36 models, a treatable intrahepatic duct dilatation was achieved. During the hands-on training, EUS-guided biliary drainage, EUS-guided transgastric gallbladder drainage, and EUS through-the-needle microbiopsy forceps procedures were feasible. Overall, 75 % of the experts and trainees evaluated the training as excellent. Conclusions We present a minimally invasive, reliable and time- effective model of extrahepatic dilation suitable for interventions. The model was less effective for intrahepatic ducts, which should be considered if intrahepatic biliary dilation is required for training.

Design and validation of a therapeutic EUS training program using a live animal model: Taking training to the next level.

Background and Objectives: EUS has evolved into a therapeutic modality for gastrointestinal disorders. Simulators, ex vivo models, and phantoms are the current teaching methods for therapeutic EUS (TEUS). We create and evaluate a high-fidelity simulated live animal model (HiFi SAM) for teaching endoscopists TEUS. Materials and Methods: Designing a curriculum that uses HiFi SAM and enables trainees to perform realistic procedures with expert mentors. Results: Twenty-seven trainees participated in a 3-day program with 6 h of theoretical and 14 h of hands using life HiFi SAM. Eighteen experts participated. Twenty-two (20-25) TEUS were defined for each HiFi SAM, and 616 were performed in all. Of 616/264 (43%) were evaluated with a mean of 88 per course (ranging between 80 and 95). Ninety-one percent (240/264) of the procedures were completed successfully. In 24, success was not achieved due to technical and/or model problems. Student rating of HiFi SAM was: 71% excellent rating (scale 8-10) and 95% excellent/good. The HiFi SAM procedure evaluation was (scale 1-5): fine-needle biopsy: 4.79, radiofrequency: 4.76, common bile duct and gallbladder drainage: 4.75, cystic drainages: 4.72, neurolysis: 4.55, microbiopsy: 4.50, and hepatogastric drainage: 4.04, with an overall satisfaction rate of 4.56 (91%). A short survey showed: 83% would recommend absolutely (17% most likely), 33% think that ITEC training was sufficient for their practice, and 66% would like additional training, especially more practice in specific techniques rather than more clinical case discussion. Regarding impact on their practice, 66% of the trainees started a new procedure and/or noted improvement in previous ones. Conclusion: HiFi SAM is a complex model; however, experts and trainees are satisfied with the training this new curriculum provided.

Democratizing Flexible Endoscopy Training: Noninferiority Randomized Trial Comparing a Box-Trainer vs a Virtual Reality Simulator to Prepare for the Fundamental of Endoscopic Surgery Exam.

BACKGROUND: A considerable number of surgical residents fail the mandated endoscopy exam despite having completed the required clinical cases. Low-cost endoscopy box trainers (BTs) could democratize training; however, their effectiveness has never been compared with higher-cost virtual reality simulators (VRSs). STUDY DESIGN: In this randomized noninferiority trial, endoscopy novices trained either on the VRS used in the Fundamental of Endoscopic Surgery manual skills (FESms) exam or a validated BT-the Basic Endoscopic Skills Training (BEST) box. Trainees were tested at fixed timepoints on the FESms and on standardized ex vivo models. The primary endpoint was FESms improvement at 1 week. Secondary endpoints were FESms improvement at 2 weeks, FESms pass rates, ex vivo tests performance, and trainees' feedback. RESULTS: Seventy-seven trainees completed the study. VRS and BT trainees showed comparable FESms improvements (25.16 ± 14.29 vs 25.58 ± 11.75 FESms points, respectively; p = 0.89), FESms pass rates (76.32% vs 61.54%, respectively; p = 0.16) and total ex vivo tasks completion times (365.76 ± 237.56 vs 322.68 ± 186.04 seconds, respectively; p = 0.55) after 1 week. Performances were comparable also after 2 weeks of training, but FESms pass rates increased significantly only in the first week. Trainees were significantly more satisfied with the BT platform (3.97 ± 1.20 vs 4.81 ± 0.40 points on a 5-point Likert scale for the VRS and the BT, respectively; p < 0.001). CONCLUSIONS: Simulation-based training is an effective means to develop competency in endoscopy, especially at the beginning of the learning curve. Low-cost BTs like the BEST box compare well with high-tech VRSs and could help democratize endoscopy training.

Why non-technical skills matter in surgery. New paradigms for surgical leaders.

The surgical literature is paying more and more attention to the topic of soft or non-technical skills (NTS), defined as those cognitive and social skills that characterize high-performing individuals and teams. NTS are essential in supporting surgeons in dealing with unexpected situations. During the COVID-19 pandemic, NTS have been considered crucial in defining situation awareness, enhancing decision making, communicating among groups and teams, and fostering leadership. With a "looking back and planning forward" approach, the current perspective aims at deepening the contribution of NTS for surgeons to deal with the unexpected challenges posed by the COVID crisis, surgical emergencies, the introduction of new technologies in clinical practice, to understand how such skills may help shape the surgical leaders of the future.

Upstaging nodal status in colorectal cancer using ex vivo fluorescence sentinel lymph node mapping: preliminary results.

BACKGROUND: Sentinel lymph node (SLN) mapping using near-infrared fluorescence (NIRF) imaging is a recent technique to improve nodal staging in several tumors. The presence of colorectal cancer (CRC) micro-metastases has recently been defined as N1 disease and no longer as N1mi, determining the need for adjuvant chemotherapy. In CRC, the reported rate of SLN micro-metastases detected by ultrastaging techniques is as high as 30%. The aim of this prospective study is to report the preliminary results of the sensitivity analysis of NIRF imaging for ex vivo SLN mapping and the research of micro-metastases in CRC, in patients with node-negative disease (NND). MATERIAL AND METHODS: On the specimen of 22 CRC patients, 1 mL of ICG (5 mg/mL) was injected submucosally around the tumor to identify SLNs. NND SLNs were further investigated with ultrastaging techniques. RESULTS: Three-hundred and sixty-three lymph nodes were retrieved (59 SLNs; mean per case: 2.7). The detection, sensitivity and false-negative rate were 100%, 100% and 0% respectively. Ultrastaging investigations showed no micro-metastases in the NND SLNs. CONCLUSIONS: The ex vivo SLN fluorescence-based detection in CRC was confirmed to be easy to perform and reliable. In this preliminary results report of an ongoing study, the SLN assay was congruent with the nodal status, as confirmed by histological investigations.

The Development and Natural History of Hiatal Hernias: A Study Using Sequential Barium Upper Gastrointestinal Series.

OBJECTIVE: The aim of this study was to use barium upper gastrointestinal series (UGI) to evaluate the development and natural history of a hiatal hernia. SUMMARY OF BACKGROUND DATA: Hiatal hernias are common but the natural history of sliding and paraesophageal type hernias is poorly understood. METHODS: We reviewed UGI reports from 1987 to 2017 using a word scanning software program to identify individuals that had a hiatal hernia. Only those with at least 2 UGI studies 5 or more years apart were selected. The studies were then reviewed. RESULTS: There were 89 individuals that met inclusion criteria. Twenty-one people had no hiatal hernia on initial UGI and over a median of 99 months a sliding hiatal hernia (SHH) developed in 16 and a PEH developed in 5 people. A SHH was present on initial UGI in 55 people and at a median of 84 months subsequent UGI showed the SHH was stable in 11 (20%), increased in size in 30 (55%), and changed to a PEH in 14 people (25%). In 13 people a PEH was present on initial UGI and over a median of 97 months it was stable in 5 and increased in size in 8 people (62%). CONCLUSIONS: We showed that both SHH and PEH can develop over time and that the majority of both increased in size on follow-up UGI study. Further, 25% of SHH became a PEH over time. Recognizing an increase in size or change in type of a hiatal hernia may be clinically relevant to help understand changing or worsening symptoms in an individual.

High Resolution Manometry in a Functioning Fundoplication - Establishing a Standard Profile: Retrospective Chart Review.

OBJECTIVE: The aim of this study was to provide a full HRM data set in patients with a normal functioning fundoplication. BACKGROUND: The Chicago classification was devised to correlate HRM values to the clinical status of patients with swallowing disorder. However, it is unclear whether those values are applicable after fundoplication as the literature is sparse. METHODS: We identified patients with pre- and postoperative HRM who had a normal functioning primary fundoplication as defined by (1) resolution of preoperative symptoms without significant postoperative side effects, (2) no dysphagia reported on a standardized questionnaire given on the day of the postoperative HRM and (3) normal acid exposure determined objectively by esophageal pH-testing. RESULTS: Fifty patients met inclusion criteria for the study. Thirty-three patients (66%) underwent complete fundoplication and 17 patients (34%) underwent posterior partial fundoplication. Postoperative HRM was performed at a median of 12 months after primary surgery. Lower esophageal sphincter (LES) values significantly increased with the addition of a fundoplication. Median integrated relaxation pressure (IRP) was 14 mm Hg ( P = 0.0001), median resting pressure 19.5 mm Hg ( P = 0.0263), and median total length LES was 3.95 cm ( P = 0.0098). The 95th percentile for IRP in a complete fundoplication was 29 versus 23 mm Hg in a partial fundoplication ( P = 0.3667). CONCLUSION: We offer a new standard manometric profile for a normally functioning fundoplication which provides a necessary benchmark for analyzing postoperative problems with a fundoplication. The previously acceptedupper limit defining esophageal outflow obstruction (IRP >20 mm Hg) is not clinically applicable after fundoplication as the majority of patients in this dysphagia-free cohort exceeded this value. Interestingly, there does not seem to be a significant difference in HRM LES values between complete and partial fundoplication.

Impact of Focused Hands-on Training Course on Practice Adoption of Advanced Endoscopic Techniques and Per-Oral Endoscopic Myotomy.

Background: Per-oral endoscopic myotomy (POEM) is a valuable tool for the treatment of foregut motility disorders. Hands-on courses are often utilized at the initial means of training in POEM. Whether such training is sufficient to allow individuals to launch an independent practice in POEM is unknown. The purpose of this study was to evaluate the successes and barriers of implementing a POEM practice after attending a hands-on course. Methods: We evaluated participants of a 2-day focused POEM training course. All participants of the course were sent a survey to assess their endoscopic practice before and after the course, concentrating on their ability to implement POEM after returning to their home institution. Results: Between 2012 and 2017, 11 POEM courses were held at our institution, with a total of 102 trainees. Fifty-five individuals responded to our survey (53.9%), most of whom were general surgeons who were already doing some therapeutic endoscopy but had not previously performed POEM. More than half (58.2%) were able to institute a POEM practice at their home institution after the course. Those that were successful in starting a POEM practice were more often those with previous advanced endoscopic experience (90.3%). Success was assisted by high rates of additional explant laboratories (43.6%) and in-person proctoring (52.4%) after completing the course. Those that did not start a POEM practice sited lack of institutional support as the main barrier, followed by problems with insurance approval, and lack of referral volume. Conclusion: Despite the complexity of the POEM procedure, a focused hands-on POEM training course is associated with a high rate of implementation of an independent POEM practice, particularly in individuals with previous advanced endoscopic experience. The largest barriers to POEM adoption are not technical factors, but rather are related to institutional and insurance factors.

Can We Identify Patients Appropriate for Same-Day Discharge After Laparoscopic Fundoplication?

Background: Patients, surgeons, and payers are interested in reducing hospital length of stay. Outpatient laparoscopic fundoplication (LF) can be done safely and cost effectively. There is low acceptance of this practice due to fear of readmission and patient dissatisfaction. Our aim was to identify factors predicting failure of same-day discharge after LF. Methods and Procedures: We simulated an outpatient setting for patients who underwent LF from 2017 to 2018 and collected the data prospectively. A perioperative pain and nausea protocol was utilized. Postoperatively, patients were given a liquid diet and oral medications, observed overnight, and then discharged after standard criteria were met. Failure was defined by the need for physician intervention after 3 hours or failure to discharge. Univariate and multivariable logistic regression analyses were performed assessing factors associated with failure. Two-sample t-test and chi-squared tests were used for significance. Results: Ninety-eight patients were included. Twenty patients failed, primarily due to the need for intravenous medications. Seven were discharged on postoperative day 1 but required physician intervention after 3 hours. Thirteen patients stayed >23 hours. Two patients were readmitted within 1 week of discharge. There was one acute recurrence, requiring reoperation, and one conversion to laparotomy. We found no statistically significant patient risk factor, comorbidity, or perioperative variable that could reliably predict failure of same-day discharge. Conclusion: This study suggests that same-day discharge after LF is safe and feasible. However, 20% of patients will unpredictably fail to meet discharge criteria.