Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy.

Background and study aims Percutaneous transhepatic cholangioscopy (PTCS) is a management option for patients in whom peroral cholangioscopy or endoscopic retrograde cholangiopancreatography (ERCP) fail. We conducted a case series on the efficacy and safety of PTCS using a cholangiopancreatoscope cleared by the US Food and Drug Administration in 2020. Patients and methods Fifty adult patients scheduled for PTCS or other cholangioscopic procedure were enrolled at seven academic medical centers and followed for 30 days after the index procedure. The primary efficacy endpoint was achievement of clinical intent by 30 days after the index PTCS procedure. Secondary endpoints included technical success, procedure time, endoscopist ratings of device attributes on a scale of 1 to 10 (best), and serious adverse events (SAEs) related to the device or procedure. Results Patients had a mean age of 64.7±15.9 years, and 60.0% (30/50) were male. Forty-four patients (88.0%) achieved clinical intent by 30 days post-procedure. The most common reasons for the percutaneous approach were past (38.0%) or anticipated (30.0%) failed ERCP. The technical success rate was 96.0% (48/50), with a mean procedure time of 37.6 minutes (SD, 25.1; range 5.0-125.0). The endoscopist rated the overall ability of the cholangioscope to complete the procedure as a mean 9.2 (SD, 1.6; range 1.0-10.0). Two patients (4.0%) experienced related SAEs, one of whom had a fatal periprocedure aspiration. Conclusions PTCS is an important endoscopic option for selected patients with impossible retrograde access or in whom ERCP fails. Because of the associated risk, this technique should be practiced by highly trained endoscopists at high-volume centers. (ClinicalTrials.gov number, NCT04580940).

Innovative Management of a Difficult Case of Hepatic Hydrothorax.

Hepatic hydrothorax affects 5%-15% of decompensated cirrhosis patients, with up to 26% being refractory to standard treatments. For those ineligible for transjugular intrahepatic systemic shunts or liver transplants, alternatives to repeated thoracentesis are limited but can include the insertion of an indwelling pleural catheter. We present the first case of the use of an automatic low-flow ascites pump (alfapump) to manage nonmalignant pleural effusion in an elderly patient with cirrhosis.

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.

Percutaneous Creation of Gastrointestinal Anastomosis-An Emerging Frontier.

This article discusses the percutaneous delivery and deployment of lumen-apposing metallic stents for the creation of percutaneous cholecysto-enteric anastomoses for internal drainage of the gallbladder.

Management of Malignant Bowel Obstruction: An Innovative Proactive Outpatient Nurse-Led Model of Care for Patients With Advanced Gynecologic Cancer.

BACKGROUND: Malignant bowel obstruction (MBO) in patients with advanced gynecologic cancer (GyCa) can negatively impact clinical outcomes and quality of life. Oncology nurses can support these patients with adequate tools/processes. PROBLEM: Patients with GyCa with/at risk of MBO endure frequent emergency or hospital admissions, impacting patient care. APPROACH: Optimizing oncology nurses' role to improve care for patients with GyCa with/at risk of MBO, the gynecology oncology interprofessional team collaborated to develop a proactive outpatient nurse-led MBO model of care (MOC). OUTCOMES: The MBO MOC involves a risk-based algorithm engaging interdisciplinary care, utilizing standardized tools, risk-based assessment, management, and education for patients and nurses. The MOC has improved patient-reported confidence level of bowel self-management and decreased hospitalization. Following education, nurses demonstrated increased knowledge in MBO management. CONCLUSIONS: An outpatient nurse-led MBO MOC can improve patient care and may be extended to other cancer centers, fostering collaboration and best practice.

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.

Safety of High-Dose 3% Sodium Tetradecyl Sulfate for Sclerotherapy of Renal Cysts in Patients with Autosomal Dominant Polycystic Kidney Disease.

This study assessed the safety profile of high-volume (>10 mL) 3% sodium tetradecyl sulfate (STS) sclerotherapy for the treatment of renal cysts in patients with autosomal dominant polycystic kidney disease. A total of 211 sclerotherapy treatments were performed in 169 patients over a 5-year period, with a comparison of 2 patient cohorts based on the STS volumes used. The first cohort (n = 112) received a high volume (greater than 10 mL) of STS, and the second cohort (n = 57) received a low volume (less than 10 mL). The minor adverse event rate for the cohorts was 14.5% and 9.6%, respectively (P = .310), with postprocedure pain being the most common event. One major adverse event occurred, for which the patient required hospitalization for infection after low-volume STS treatment. Doses of STS higher than those currently recommended by the Food and Drug Administration for intravascular use allow large renal cysts to be treated safely in the setting of autosomal dominant polycystic kidney disease.

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.

Percutaneous Transgastric Duodenal Stenting and Gastrostomy Repair Using a Vascular Closure Device: Proof of Concept in a Porcine Model.

Introduction. Gastroduodenal stenting is efficacious and safe in both benign and malignant foregut diseases. Transgastric duodenal stenting has been described and however requires a gastrostomy tube to remain in situ for 4 to 6 weeks post-procedure which can lead to complications. We present a technique for immediate gastric repair using a suture-mediated vascular closure device, without the need for a gastrostomy tube in porcine models. Methods. Percutaneous access into the stomach was achieved using fluoroscopy. Two or 3 Perclose Proglide devices were pre-deployed. The tract was dilated and a wire advanced into the distal duodenum. A 15.5 cm covered enteric stent was delivered through the gastrostomy, deployed and position confirmed. The gastrostomy was closed using Perclose Proglide sutures. Necropsy leak pressure measurement was performed to assess integrity of gastrostomy closure in the porcine models. Results. Two (n = 8) or 3 (n = 2) Perclose Proglide devices were deployed in ten porcine models, with 1 misfire (4.5%). Percutaneous transgastric access and stent delivery was successful in all porcine models. Mean leak pressure in the animals with adequately deployed devices was 219 mmHg (range 172 mmHg-270 mmHg). Conclusion. This study demonstrates percutaneous transgastric duodenal stenting with immediate gastric repair using suture-mediated vascular closure devices is a feasible procedure.

A curriculum to democratize and standardize flexible endoscopy fundamental knowledge and skills: a critical review of the first 5 years of a surgical endoscopy university diploma.

BACKGROUND: As flexible endoscopy offers many advantages to patients, access to training should be aggressively encouraged. In 2014, the IRCAD-IHU-Strasbourg launched a year-long university diploma using advanced education methods to offer surgeons and gastroenterologists high-quality, personalized training in flexible endoscopy. This paper describes and critically reviews the first 5 years of the University Diploma in Surgical Endoscopy (UDSE). METHODS: The UDSE aims to progressively transmit theoretical knowledge, clinical judgment, and practical skills on basic and advanced flexible endoscopy. The 300-h year-long curriculum is composed of 100 h of online lectures with tests, 150 h of clinical rotations and 50 h of hands-on sessions. The hands-on training is delivered through validated mechanical simulators, virtual reality simulators, and specifically designed ex vivo and in vivo animal models. Participants' demographics, training, and clinical experience were recorded. Trainees' evaluations of each online lecture, hands-on training, and clinical rotations were assessed using a Likert scale from 1 (not satisfactory) to 5 (outstanding). Trainees' skill progression was evaluated using the Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) proficiency test. Finally, clinical uptake was surveyed. RESULTS: 162 (79.01% males) trainees from 38 countries enrolled and successfully completed the first 5 courses. The vast majority of the trainees were surgeons and 19.14% were gastroenterologist. Sixty-nine (42.59%) participants were residents and 97 (56.79%) had no prior experience in flexible endoscopy. The online lectures, on-site sessions, and clinical rotations were highly appreciated receiving an overall average score of 4.33/5, 4.56/5, 4.43/5, respectively. Trainees' endoscopic skills improved significantly (16.68 vs. 20.53 GAGES scores; p = 0.016). At an average of 18.83 months following the course, 31 alumni (77.50% of repliers) started to use a flexible endoscope in their practice. CONCLUSIONS: Over its 5-year evolution, the UDSE has proven to be a valid means to ease access to the fundamental knowledge, practical skills, and clinical judgment necessary to achieve proficiency in surgical endoscopy.

Development and prospective validation of a scoring system for the Basic Endoscopic Skills Training (BEST) box.

AIMS: The increased use of endoscopy as a minimally invasive therapeutic technique has created a great demand for endoscopic training. The Basic Endoscopic Skills Training (BEST) box provides a low-cost solution by adapting the Fundamentals of Laparoscopic Surgery (FLS) box for flexible endoscopic simulation. The BEST box consists of six endoscopic tasks with a 5-min time limit per task. This study aims to develop a scoring system for objective evaluation of user performance. METHODS: A total of 165 participants were tested on the BEST box. Participants were divided into two groups: retrospective analysis (n = 100) and prospective analysis (n = 65). From the retrospective group, 55 individuals were also scored on the Global Assessment of Gastrointestinal Endoscopic Skills-Upper Endoscopy (GAGES-UE). Linear regression between user performance on BEST box and GAGES-UE was performed to develop the scoring system. Receiver Operating Characteristic curve was used to determine a threshold score to help users appreciate their endoscopic expertise. Prospective scoring of 65 individuals was then performed using the formula developed (20 experts and 45 trainees). RESULTS: The minimum and maximum possible scores are 30 and 110, respectively. Retrospective analysis showed that the scoring system was able to distinguish between experts and trainees (p < 0.001), correlated with GAGES-UE (p < 0.001), and had a reliability constant of r = 0.765 (p < 0.001). On prospective testing using the scoring system the expert group received a final average score of 92, whereas the average score for the trainee group was 61 (p < 0.001). CONCLUSIONS: The developed BEST box scoring system correlates with the experience level of the test taker as well as with the GAGES-UE scoring system. The results of this study add further evidence to the validity of the BEST box as an effective, low-cost endoscopic simulator with the scores used by trainees to track their performance level overtime.

Safety and Efficacy of Percutaneous Gallstone Extraction in High-Risk Patients: An Alternative to Cholecystectomy or Long-Term Drainage?

BACKGROUND: Acute cholecystitis in nonsurgical candidates is often managed with cholecystostomy tube drainage. After symptom resolution, management options include cholecystectomy, long-term tube drainage, or tube removal. Percutaneous cholecystolithotomy (PCCL) can offer another therapeutic option for patients who are poor operative candidates. STUDY DESIGN: A retrospective study of PCCL performed between December 2000 and September 2017 was conducted. Demographic characteristics, procedure details, gallstone-related complications, procedure-related complications, readmission, and mortality data were collected. RESULTS: Seventy-five patients were identified (52.0% male, 48.0% female, mean ± SD age 75.6 ± 13.9 years). Mean ± SD follow-up time was 2.8 ± 3.7 years. Most of the patients (90.7%) had an American Society of Anesthesiologists physical status classification of 3 or 4. Eleven patients (14.7%) had failed earlier cholecystectomy. A total of 96 PCCL procedures were performed, and complete gallstone removal was achieved in 68 of 75 patients (90.7%), including all patients with previously aborted cholecystectomy. The 30-day and 90-day readmission rates were 4% and 8%, respectively. Three patients (3.9%) subsequently underwent cholecystectomy after PCCL. Ten (10.4%) procedure-related complications (Clavien-Dindo grade I and II) and 17 (22.7%) gallstone-related complications occurred during the follow-up period. Postprocedural choledocholithiasis occurred in 6 patients (8.0%). Recurrent gallstones developed in 5 patients (6.3%) (3 patients undergoing cholecystectomy and 2 patients treated with cholecystostomy tube). CONCLUSIONS: PCCL is a viable option for management of symptomatic gallbladder stones in high-risk surgical patients. There is a high technical success rate, even in patients with earlier failed cholecystectomy. Most patients (77.3%) avoided gallstone-related complications after the procedure.

Automatic task recognition in a flexible endoscopy benchtop trainer with semi-supervised learning.

PURPOSE: Inexpensive benchtop training systems offer significant advantages to meet the increasing demand of training surgeons and gastroenterologists in flexible endoscopy. Established scoring systems exist, based on task duration and mistake evaluation. However, they require trained human raters, which limits broad and low-cost adoption. There is an unmet and important need to automate rating with machine learning. METHOD: We present a general and robust approach for recognizing training tasks from endoscopic training video, which consequently automates task duration computation. Our main technical novelty is to show the performance of state-of-the-art CNN-based approaches can be improved significantly with a novel semi-supervised learning approach, using both labelled and unlabelled videos. In the latter case, we assume only the task execution order is known a priori. RESULTS: Two video datasets are presented: the first has 19 videos recorded in examination conditions, where the participants complete their tasks in predetermined order. The second has 17 h of videos recorded in self-assessment conditions, where participants complete one or more tasks in any order. For the first dataset, we obtain a mean task duration estimation error of 3.65 s, with a mean task duration of 159 s ([Formula: see text] relative error). For the second dataset, we obtain a mean task duration estimation error of 3.67 s. We reduce an average of 5.63% in error to 3.67% thanks to our semi-supervised learning approach. CONCLUSION: This work is the first significant step forward to automate rating of flexible endoscopy students using a low-cost benchtop trainer. Thanks to our semi-supervised learning approach, we can scale easily to much larger unlabelled training datasets. The approach can also be used for other phase recognition tasks.

An alternative percutaneous technique for gallbladder drainage using lumen-apposing metal stents.

BACKGROUND: Cholecystostomy is commonly performed in high-risk patients with acute cholecystitis. However, internal drainage may be more desirable in patients as it is associated with lower complication rates. This paper describes an image-guided, percutaneous technique for internal gallbladder drainage using a covered lumen-apposing metal stent (LAMS) and assesses its feasibility and safety in a porcine model. METHODS: Procedures were performed on 30-kg pigs. Under ultrasound and fluoroscopic guidance, a percutaneous puncture was performed through-and-through the gallbladder into the stomach. A guidewire was placed and a 12Fr sheath was advanced through which a 10-mm LAMS was deployed. Its distal flange was deployed in the gastric lumen, and its proximal flange in the gallbladder. The cholecystoenteric anastomosis was examined by means of endoscopy, laparoscopy, and necropsy. RESULTS: Technical success was 100% (7/7). Procedure times decreased with experience and improvements in technique (median: 22 min). Contrast injection demonstrated free flow through the stent with no leakage. Necropsy confirmed appropriate stent position with good apposition of gallbladder and stomach, and no intraprocedural complications were detected. CONCLUSIONS: Image-guided, percutaneous, internal gallbladder drainage using a LAMS is safe and feasible in a porcine model. This technique may be an alternative to endoscopic ultrasound-guided stent placement and external cholecystostomy tube drainage.

Correlation of surgical trainee performance on laparoscopic versus endoscopic simulation.

BACKGROUND: Both laparoscopy and endoscopy are image-based procedures, which are less intuitive than traditional open surgery and require extensive training to reach adequate proficiency. Currently, there is lack of understanding as to how the skills in one image-based procedure translate to another, such as endoscopy to laparoscopy and vice versa. The aim of our study was to explore the relationship between endoscopic and laparoscopic skills using a Fundamentals of Laparoscopic Surgery (FLS) trainer, a traditional virtual reality endoscopic trainer and a "desk-top" endoscopic physical simulator. METHODS: Senior surgical residents from across Canada participating in an advanced laparoscopic foregut training course were enrolled in the study. Participants were assessed performing the FLS laparoscopic suturing task, the Endobubble 2 task (Simbionix, GI Mentor), and a forward viewing peg transfer on the novel Basics in Endoscopic Skills Training Box (BEST Box). RESULTS: There was significant correlation between the participant's skill in simulated laparoscopic suturing and simulated endoscopic skill using the BEST box (Pearson coefficient (r) was 0.551 (p = 0.033) and the coefficient of determination (r2) was 0.304). There was a trend towards correlation between laparoscopic suturing time and Endobubble 2 score, but this did not reach statistical significance (r = 0.458, p = 0.086; r2 = 0.210). CONCLUSIONS: Performance in the two physical simulators, laparoscopic suturing and simulated flexible endoscopy using the BEST box, showed a correlation. This study adds to the growing body of evidence that laparoscopic and endoscopic skills are complementary and has the potential to impact simulation training involving both skill sets.

Optimizing the Care of Malignant Bowel Obstruction in Patients With Advanced Gynecologic Cancer.

PURPOSE: Malignant bowel obstruction (MBO) is a common and distressing complication in women with advanced gynecologic cancer. A pilot, interprofessional MBO program was launched in 2016 at a large Canadian tertiary cancer center to integrate these patients' complex care needs across multiple disciplines and support women with MBO. METHOD: Retrospective analysis to evaluate the outcomes of women with advanced gynecologic cancer who were admitted to hospital because of MBO, before (2014 to 2016: baseline group) and after (2016 to 2018) implementation of the MBO program. RESULTS: Of the 169 women evaluated, 106 and 63 were in the baseline group and MBO program group, respectively. Most had ovarian cancer (n = 124; 73%) and had small-bowel obstruction (n = 131; 78%). There was a significantly shorter cumulative hospital length of stay (LOSsum) within the first 60 days of MBO diagnosis in the MBO program group compared with the baseline group (13 v 22 days, respectively; adjusted P = .006). The median overall survival for women treated in the MBO program was also significantly longer compared with the baseline group (243 v 99 days, respectively; adjusted P = .002). Using the interprofessional MBO care platform, a greater proportion of patients received palliative chemotherapy (83% v 56%) and less surgery (11% v 21%) in the MBO program group than in the baseline group, respectively. A subgroup of women (n = 11) received total parenteral nutrition for longer than 6 months. CONCLUSION: Implementation of a comprehensive, interprofessional MBO program significantly affects patient care and may improve outcomes. Unique to this MBO program is an integrated outpatient model of care and education that empowers patients to recognize MBO symptoms for early intervention.

Gastrointestinal Hormones Manipulation to Counteract Metabolic Syndrome Using Duodenal Targeted Embolization.

PURPOSE: Targeted embolization of gastrointestinal (GI) arteries can modify hormonal production. We aimed to evaluate the impact of the embolization of the gastroduodenal artery (GDA) on the activity of foregut mucosa. METHODS: The GDA's duodenal branch was embolized in 12 Yucatan pigs using 100-300 µm (group A; n = 4) or 300-500 µm (group B; n = 4) microspheres, followed by coiling of the branch. In 4 animals (sham), only saline was injected. The levels of GI hormones (ghrelin, glucose-dependent insulinotropic peptide [GIP], glucagon-like peptide-1 [GLP-1], insulin, peptide YY [PYY], leptin) and the gene expression of sodium-glucose-linked transporter-1 (SGLT-1) and glucose transporter-2 (GLUT-2) were assessed before (T0), 1 hour (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after embolization. RESULTS: In group A, a segmental duodenal stenosis occurred in all cases, which required balloon dilatation. There was a significant drop in the baseline glycemia in group A at T1 and T4 versus sham. Ghrelin was reduced in group A versus baseline and versus group B at T2 and T3 and versus sham at T1 and T3. Insulin was significantly lower in group A versus B at T1 and at T4 but not versus sham. SGLT-1 expression increased in B and sham at T4, while it remained stable in group A. GLUT-2 expression increased in sham at T4 but not in A or B. CONCLUSIONS: GDA embolization induced a decrease in ghrelin production and influenced expression of glucose carriers in the foregut mucosa.