Impact of Annual Case Volume on Colorectal Endoscopic Submucosal Dissection Outcomes in a Large Prospective Cohort Study.

INTRODUCTION: The adoption of colorectal endoscopic submucosal dissection (ESD) is still limited in the West. A recent randomized trial showed that ESD is more effective and only slightly riskier than piecemeal endoscopic mucosal resection; reproducibility outside expert centers was questioned. We evaluated the results according to the annual case volume in a multicentric prospective cohort. METHODS: Between September 2019 and September 2022, colorectal ESD was consecutively performed at 13 participating centers classified as low volume (LV), middle volume (MV), and high volume (HV). The main procedural outcomes were assessed. Multivariate and propensity score matching analyses were performed. RESULTS: Three thousand seven hundred seventy ESDs were included. HV centers treated larger and more often colonic lesions than MV and LV centers. En bloc , R0, and curative resection rates were 95.2%, 87.4%, and 83.2%, respectively, and were higher at HV than at MV and LV centers. HV centers also achieved a faster dissection speed. Delayed bleeding and surgery for complications rates were 5.4% and 0.8%, respectively, without significant differences. The perforation rate (overall: 9%) was higher at MV than at LV and HV centers. Lesion characteristics, but not volume center, were independently associated with both R1 resection and perforation. However, after propensity score matching, R0 rates were significantly higher at HV than at LV centers, and perforation rates were significantly higher at MV than at HV centers. DISCUSSION: Colorectal ESD can be successfully implemented in the West, even in nonexpert centers. However, difficult lesions must still be referred to experts.

Success Rate of Fiducial Markers Placement for Treatment of Esophageal or Rectal Cancers, a prospective multicenter study (FIDECHO study).

BACKGROUND AND STUDY AIMS: Endoscopy Ultra-Sound (EUS)-guided fiducial marker placement in patients with esophageal or rectal cancer who have been referred for radiation therapy lacks data regarding its feasibility and safety. The aim of this study was to assess the success rate of EUS-guided fiducial marker placement in these indications. PATIENTS AND METHODS: This prospective multicenter study enrolled patients with rectal or esophageal tumor, who were treated between March 2017 and June 2021. The primary endpoint was the success of fiducial markers placement under EUS guidance utilizing the preloaded 22-gauge EchoTip Ultra Fiducial needle® (Cook Medical, Limerick, Ireland), defined by the ability to release fiducials at least at proximal and distal ends of the tumor. The secondary endpoints were the adverse events, length of procedure, and remaining fiducial markers throughout radiation therapy. RESULTS: A total of 33 patients were included in this study, with a mean age of 64.2 years ±11.3, and 66.7% of males. Twenty patients had rectal adenocarcinoma, and 13 had esophageal malignancies. The success rate of fiducial markers placement was 93.9%. Markers could only be released at the proximal end of the tumor in two cases. The average procedure time (±SD) was 12.5 min (±4.8). The number of fiducial markers placed for each patient was 3.8 (±0.5). No adverse event was reported. At the end of radiotherapy, markers were still visible on imaging in all patients. CONCLUSION: This prospective multicenter study highlights the safety and high success of the placement of fiducial markers under EUS, for rectal and esophageal tumors, without adverse event, and with a short procedure time. Fiducial markers remain in place over time during radiation therapy. CLINICALTRIALS: gov ID: NCT03057288.

Impact of linked color imaging on the proximal adenoma miss rate: a multicenter tandem randomized controlled trial (the COCORICO trial).

BACKGROUND: Missed lesions are common during standard colonoscopy and are correlated with post-colonoscopy colorectal cancer. Contrast-enhanced technologies have recently been developed to improve polyp detection. We aimed to evaluate the impact of linked color imaging (LCI) on the proximal adenoma miss rate in routine colonoscopy. METHODS: This national, multicenter, tandem, randomized trial compared the outcomes of colonoscopy with white-light imaging (WLI) versus LCI for polyp detection in the right colon. Two consecutive examinations of the right colon (upstream of the hepatic flexure) were made with WLI and LCI by the same operator. First-pass examination by WLI or LCI was randomized 1:1 after cecal intubation. According to statistical calculations, 10 endoscopy units had to include approximately 700 patients. The primary outcome was proximal adenoma miss rate. Secondary outcomes were the proximal miss rates for sessile serrated lesions (SSL), advanced adenomas, and polyps. RESULTS: 764 patients were included from 1 January 2020 to 22 December 2022, and 686 patients were randomized (345 WLI first vs. 341 LCI first). Both groups were comparable in terms of demographics and indications. The proximal adenoma miss rate was not significantly higher in the WLI-first group (36.7%) vs. the LCI-first group (31.8%) (estimated mean absolute difference: 4.9% [95%CI -5.2% to 15.0%], P = 0.34). There was also no significant difference in miss rates for SSLs, advanced adenomas, and polyps in the proximal colon. CONCLUSIONS: In contrast to previous data, this study does not support the benefit of LCI to the proximal adenoma miss rate in routine colonoscopy.

A computer-aided detection system in the everyday setting of diagnostic, screening, and surveillance colonoscopy: an international, randomized trial.

BACKGROUND: Computer-aided detection (CADe) has been developed to improve detection during colonoscopy. After initial reports of high efficacy, there has been an increasing recognition of variability in the effectiveness of CADe systems. The aim of this study was to evaluate a CADe system in a varied colonoscopy population. METHODS: A multicenter, randomized trial was conducted at seven hospitals (both university and non-university) in Europe and Canada. Participants referred for diagnostic, non-immunochemical fecal occult blood test (iFOBT) screening, or surveillance colonoscopy were randomized (1:1) to undergo CADe-assisted or conventional colonoscopy by experienced endoscopists. Participants with insufficient bowel preparation were excluded from the analysis. The primary outcome was adenoma detection rate (ADR). Secondary outcomes included adenomas per colonoscopy (APC) and sessile serrated lesions (SSLs) per colonoscopy. RESULTS: 581 participants were enrolled, of whom 497 were included in the final analysis: 250 in the CADe arm and 247 in the conventional colonoscopy arm. The indication was surveillance in 202/497 colonoscopies (40.6 %), diagnostic in 199/497 (40.0 %), and non-iFOBT screening in 96/497 (19.3 %). Overall, ADR (38.4 % vs. 37.7 %; P = 0.43) and APC (0.66 vs. 0.66; P = 0.97) were similar between CADe and conventional colonoscopy. SSLs per colonoscopy was increased (0.30 vs. 0.19; P = 0.049) in the CADe arm vs. the conventional colonoscopy arm. CONCLUSIONS: In this study conducted by experienced endoscopists, CADe did not result in a statistically significant increase in ADR. However, the ADR of our control group substantially surpassed our sample size assumptions, increasing the risk of an underpowered trial.

Surgical versus endoscopic gastroenterostomy for gastric outlet obstruction: a retrospective multicentric comparative study of technical and clinical success.

PURPOSE: Gastric outlet obstruction (GOO) is mainly due to advanced malignant disease. GOO can be treated by surgical gastroenterostomy (SGE), endoscopic enteral stenting (EES), or endoscopic ultrasound-guided gastroenterostomy (EUS-GE) to improve the quality of life. METHODS: Between 2009 and 2022, patients undergoing SGE or EUS-GE for GOO were included at three centers. Technical and clinical success rates, post-procedure adverse events (AEs), length of hospital stay (LOS), 30-day all-cause mortality, and recurrence of GOO were retrospectively analyzed and compared between SGE and EUS-GE. Predictive factors for technical and clinical failure after SGE and EUS-GE were identified. RESULTS: Of the 97 patients included, 56 (57.7%) had an EUS-GE and 41 (42.3%) had an SGE for GOO, with 62 (63.9%) GOO due to malignancy and 35 (36.1%) to benign disease. The median follow-up time was 13,4 months (range 1 days-106 months), with no difference between the two groups (p = 0.962). Technical (p = 0.133) and clinical (p = 0.229) success rates, severe morbidity (p = 0.708), 30-day all-cause mortality (p = 0.277) and GOO recurrence (p = 1) were similar. EUS-GE had shorter median procedure duration (p < 0.001), lower post-procedure ileus rate (p < 0.001), and shorter median LOS (p < 0.001) than SGE. In univariate analysis, no risk factors for technical or clinical failure in SGE were identified and abdominal pain reported before the procedure was a risk factor for technical failure in the EUS-GE group. No risk factor for clinical failure was identified for EUS-GE. In the subgroup of GOO due to benign disease, SGE was associated with better technical success (p = 0.035) with no difference in clinical success rate compared to EUS-GE (p = 1). CONCLUSION: EUS-GE provides similar long-lasting symptom relief as SGE for GOO whether for benign or malignant disease. SGE may still be indicated in centers with limited experience with EUS-GE or may be reserved for patients in whom endoscopic technique fails.

Artificial intelligence for characterization of colorectal polyps: Prospective multicenter study.

Background and study aims Optical diagnosis poses challenges to implementation of "resect and discard" strategies. This study aimed to assess the feasibility and performance of a new commercially available system for colorectal polyps. Patients and methods Nine expert endoscopists in three centers performed colonoscopies using artificial intelligence-equipped colonoscopes (CAD EYE, Fujifilm). Histology and predictions were compared, with hyperplastic polyps and sessile serrated lesions grouped for analysis. Results Overall, 253 polyps in 119 patients were documented (n=152 adenomas, n=78 hyperplastic polyps, n=23 sessile serrated lesions). CAD EYE detected polyps before endoscopists in 81 of 253 cases (32%). The mean polyp size was 5.5 mm (SD 0.6 mm). Polyp morphology was Paris Ip (4 %), Is (28 %), IIa (60 %), and IIb (8 %). CAD EYE achieved a sensitivity of 80%, specificity of 83%, positive predictive value (PPV) of 96%, and negative predictive value (NPV) of 72%. Expert endoscopists had a sensitivity of 88%, specificity of 83%, PPV of 96%, and NPV of 72%. Diagnostic accuracy was similar between CAD EYE (81%) and endoscopists (86%). However, sensitivity was greater with endoscopists as compared with CAD EYE ( P <0.05). CAD EYE classified sessile serrated lesions as hyperplasia in 22 of 23 cases, and endoscopists correctly classified 16 of 23 cases. Conclusions The CAD EYE system shows promise for detecting and characterizing colorectal polyps. Larger studies are needed, however, to confirm these findings.