Endoscopic submucosal dissection with adaptive traction strategy: first prospective multicenter study (with video).

BACKGROUND AND AIMS: Traction has become the reference strategy for colorectal endoscopic submucosal dissection (ESD). One of its major limitations is that the force of traction decreases as dissection progresses. The ATRACT traction device (ATRACT Device and Co, Lyon, France) uses a pulley system to increase traction during the procedure, making it easier and faster. A retrospective study of 54 cases showed interesting results in terms of efficacy and safety throughout the digestive tract. We sought to confirm these initial results with a prospective study of resections of colorectal lesions. METHODS: In this prospective multicenter study, 5 experienced operators from 3 different centers each performed 10 procedures using the ATRACT device consecutively for all conventional colorectal ESDs measuring between 4 and 10 cm in conventional locations (no recurrent lesions, appendicular, of the ileocecal valve, in contact with the pectinate line, or measuring more than two-thirds of the circumference). RESULTS: Between November 2022 and April 2023, 50 ESDs were performed in 49 patients. On average, the main diameter of the lesions was 66.6 mm, with a surface area of 3066 mm2. The mean operating time was 55.2 minutes, resulting in a mean resection speed of 61.4 mm2/min. En bloc and R0 resection rates were 100% and 98%, respectively. Resections were curative in 94% of cases. Four (8%) perforations occurred, all of which were closed endoscopically without the need for surgery. One (2%) case of delayed hemorrhage was noted. To date, this is the series with the highest resection speeds in the literature for colorectal ESD. For comparison, previous studies reported a speed of 23.5 mm2/min using the "pocket" strategy and a speed of 39.1 mm2/min using the double-clip traction technique. These results need to be confirmed in larger studies and in nonexpert centers. CONCLUSIONS: This prospective evaluation confirms the efficacy and safety of the adaptive traction strategy with the ATRACT device for colorectal ESD with high resection speed.

Endoscopic submucosal dissection assisted by adaptive traction: results of the first 54 procedures.

BACKGROUND : Good submucosal exposure is key to successful endoscopic submucosal dissection (ESD) and can be achieved with various traction devices. Nevertheless, these devices have a fixed traction force that tends to decrease as the dissection progresses. In contrast, the ATRACT adaptive traction device increases traction during the procedure. METHODS : In this retrospective analysis of prospectively collected data (from a French database), we analyzed ESD procedures performed with the ATRACT device between April 2022 and October 2022. The device was used consecutively whenever possible. We collected details of lesion characteristics, procedural data, histologic outcomes, and clinical consequences for the patient. RESULTS : 54 resections performed in 52 patients by two experienced operators (46 procedures) and six novices (eight procedures) were analyzed. The ATRACT devices used were the ATRACT-2 (n = 21), the ATRACT 2 + 2 (n = 30), and the ATRACT-4 (n = 3). Four adverse events were observed: one perforation (1.9 %), which was closed endoscopically, and three delayed bleeding events (5.5 %). The R0 rate was 93 %, resulting in curative resection in 91 % of cases. CONCLUSION: ESD using the ATRACT device is safe and effective in the colon and rectum, but can also be used to assist with procedures in the upper gastrointestinal tract. It may be particularly useful in difficult locations.

Western outcomes of circumferential endoscopic submucosal dissection for early esophageal squamous cell carcinoma.

BACKGROUND AND AIMS: Circumferential endoscopic submucosal dissection (cESD) in the esophagus has been reported to be feasible in small Eastern case series. We assessed the outcomes of cESD in the treatment of early esophageal squamous cell carcinoma (ESCC) in Western countries. METHODS: We conducted an international study at 25 referral centers in Europe and Australia using prospective databases. We included all patients with ESCC treated with cESD before November 2022. Our main outcomes were curative resection according to European guidelines and adverse events. RESULTS: A total of 171 cESDs were performed on 165 patients. En bloc and R0 resections rates were 98.2% (95% confidence interval [CI], 95.0-99.4) and 69.6% (95% CI, 62.3-76.0), respectively. Curative resection was achieved in 49.1% (95% CI, 41.7-56.6) of the lesions. The most common reason for noncurative resection was deep submucosal invasion (21.6%). The risk of stricture requiring 6 or more dilations or additional techniques (incisional therapy/stent) was high (71%), despite the use of prophylactic measures in 93% of the procedures. The rates of intraprocedural perforation, delayed bleeding, and adverse cardiorespiratory events were 4.1%, 0.6%, and 4.7%, respectively. Two patients died (1.2%) of a cESD-related adverse event. Overall and disease-free survival rates at 2 years were 91% and 79%. CONCLUSIONS: In Western referral centers, cESD for ESCC is curative in approximately half of the lesions. It can be considered a feasible treatment in selected patients. Our results suggest the need to improve patient selection and to develop more effective therapies to prevent esophageal strictures.

Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial.

BACKGROUND: Endoscopic resection of adenomas prevents colorectal cancer, but the optimal technique for larger lesions is controversial. Piecemeal endoscopic mucosal resection (EMR) has a low adverse event (AE) rate but a variable recurrence rate necessitating early follow-up. Endoscopic submucosal dissection (ESD) can reduce recurrence but may increase AEs. OBJECTIVE: To compare ESD and EMR for large colonic adenomas. DESIGN: Participant-masked, parallel-group, superiority, randomized controlled trial. (ClinicalTrials.gov: NCT03962868). SETTING: Multicenter study involving 6 French referral centers from November 2019 to February 2021. PARTICIPANTS: Patients with large (≥25 mm) benign colonic lesions referred for resection. INTERVENTION: The patients were randomly assigned by computer 1:1 (stratification by lesion location and center) to ESD or EMR. MEASUREMENTS: The primary end point was 6-month local recurrence (neoplastic tissue on endoscopic assessment and scar biopsy). The secondary end points were technical failure, en bloc R0 resection, and cumulative AEs. RESULTS: In total, 360 patients were randomly assigned to ESD (n = 178) or EMR (n = 182). In the primary analysis set (n = 318 lesions in 318 patients), recurrence occurred after 1 of 161 ESDs (0.6%) and 8 of 157 EMRs (5.1%) (relative risk, 0.12 [95% CI, 0.01 to 0.96]). No recurrence occurred in R0-resected cases (90%) after ESD. The AEs occurred more often after ESD than EMR (35.6% vs. 24.5%, respectively; relative risk, 1.4 [CI, 1.0 to 2.0]). LIMITATION: Procedures were performed under general anesthesia during hospitalization in accordance with the French health system. CONCLUSION: Compared with EMR, ESD reduces the 6-month recurrence rate, obviating the need for systematic early follow-up colonoscopy at the cost of more AEs. PRIMARY FUNDING SOURCE: French Ministry of Health.

Factors associated with early failure of peroral endoscopic myotomy in achalasia.

BACKGROUND AND AIMS: Achalasia can be treated very effectively with peroral endoscopic myotomy (POEM), but factors associated with early failure remain to be determined, especially in European cohorts. METHODS: All consecutive adult patients who underwent a first POEM to treat primary achalasia were included in this multicenter retrospective study. Early failure was defined by an Eckardt score (ES) >3 at 3 months after POEM. When evaluating factors predictive of early failure, 2 cohorts were considered: one consisted of the total population, for whom only basic variables were collected, and the other a cohort built for a case-control study that included matched early-failure and early-success patients (ratio, 1:2). RESULTS: Among 746 patients, the early failure rate was 9.4%. Predictive factors were age ≤45 years (P = .019), achalasia types I and III (P < .001), and the development of a severe adverse event during the procedure (P = .023). In the case-control study, the only additional independent risk factor for early failure was a high pre-POEM ES (P = .001). Only the retrosternal pain subscore was significantly associated with the early failure rate. CONCLUSION: The early failure rate of POEM used to treat primary achalasia is <10%. Younger age, type I/III achalasia, and a high pre-POEM ES were significantly associated with failure.

Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study.

BACKGROUND AND AIMS: Endoscopic resection is standard treatment for adenomatous colorectal lesions. Depending on lesion morphology and resection technique, recurrence can occur. Scarred adenomas are challenging to resect and may require surgical management. This study evaluated the safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions. METHODS: This single-arm, prospective, multicenter study was conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary end points were technical success (the ability of the device to resect the lesion[s] without use of other resection devices without device-related serious adverse events [AEs]) and safety (the occurrence of AEs through 90 days). Secondary end points included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens. RESULTS: Sixty-five patients were in the intention-to-treat/safety analysis population. Primary analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP patients were solely treated by using the EPR device. Technical success was achieved in 44 (98%) patients. Three (5%) serious AEs occurred: 2 delayed self-limited bleeds and 1 perforation. Nonserious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathologic diagnosis of tissue specimens were achieved in all patients. Twenty-one (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis. CONCLUSIONS: EPR is safe and effective for benign, persistent, large (>20 mm), scarred colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. A persistence rate of 46.7% indicates that >1 treatment is necessary for effective endoscopic treatment. (Clinical trial registration number: NCT04203667.).

First report from the International Evaluation of Endoscopic classification Japan NBI Expert Team: International multicenter web trial.

OBJECTIVES: Narrow-band imaging (NBI) contributes to real-time optical diagnosis and classification of colorectal lesions. The Japan NBI Expert Team (JNET) was introduced in 2011. The aim of this study was to explore the diagnostic accuracy of JNET when applied by European and Japanese endoscopists not familiar with this classification. METHODS: This study was conducted by 36 European Society of Gastrointestinal Endoscopy (ESGE) and 49 Japan Gastroenterological Endoscopy Society (JGES) non-JNET endoscopists using still images of 150 lesions. For each lesion, nonmagnified white-light, nonmagnified NBI, and magnified NBI images were presented. In the magnified NBI, the evaluation area was designated by region of interest (ROI). The endoscopists scored histological prediction for each lesion. RESULTS: In ESGE members, the sensitivity, specificity, and accuracy were respectively 73.3%, 94.7%, and 93.0% for JNET Type 1; 53.0%, 64.9%, and 62.1% for Type 2A; 43.9%, 67.7%, and 55.1% for Type 2B; and 38.1%, 93.7%, and 85.1% for Type 3. When Type 2B and 3 were considered as one category of cancer, the sensitivity, specificity, and accuracy for differentiating high-grade dysplasia and cancer from the others were 59.9%, 72.5%, and 63.8%, respectively. These trends were the same for JGES endoscopists. CONCLUSION: The diagnostic accuracy of the JNET classification was similar between ESGE and JGES and considered to be sufficient for JNET Type 1. On the other hand, the accuracy for Types 2 and 3 is not sufficient; however, JNET 2B lesions should be resected en bloc due to the risk of cancers and JNET 3 can be treated by surgery due to its high specificity.

Gastrointestinal endoscopy devices and the European Union Medical Device Regulation: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

Gastrointestinal endoscopy is largely dependent on medical devices. The European Union (EU) has recently introduced stricter rules and regulations for the approval of medical devices. This has consequences both for endoscopists and for patients. The new regulations increase the need for clinical trials and observational studies for new and current devices used in endoscopy to ensure clinical benefit and reduce patient harm. European endoscopy environments should facilitate industry-sponsored clinical trials and registry studies to meet the demand for robust data on endoscopic devices as required in the new legislation. The European Society of Gastrointestinal Endoscopy (ESGE) will play an active role in the establishment of the new system.The EU is establishing independent expert panels for device regulation in gastroenterology and hepatology, including endoscopy, that are charged with assessing the requirements for device testing. The ESGE encourages endoscopists with expertise in the technical and clinical performance of endoscopy devices to apply for expert panel membership. The ESGE has provided information for interested endoscopists on the ESGE website. Private European companies called "notified bodies" are entitled to conduct device approval for the EU. The ESGE will actively engage with these notified bodies for topics related to the new endoscopy device approval process to ensure continued access to high quality endoscopy devices for endoscopists in Europe.

Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study.

This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4 . Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II-III study investigated this issue. The phase II dose-finding part of the study evaluated H2 , CH4 , and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).

High proficiency of esophageal endoscopic submucosal dissection with a "tunnel + clip traction" strategy: a large French multicentric study.

BACKGROUND: Esophageal endoscopic submucosal dissection (ESD) is the gold standard for the treatment of precancerous lesions or superficial esophageal cancers. This procedure is currently performed by expert endoscopists only, and poorly standardized. We aimed to assess the technical results and outcomes of a "tunnel + clip" strategy for esophageal ESD procedures performed by less experienced operators for the treatment of superficial neoplasms. METHODS: All consecutive esophageal ESDs performed with the "tunnel + clip" technique for patients with early esophageal cancer in 3 centers were enrolled. Procedural characteristics, clinical outcomes, and complications were recorded. RESULTS: Among 195 esophageal ESD procedures performed, early adenocarcinomas or high-grade dysplasia complicating Barrett's esophagus were predominant (132/195, 67.7%) compared with early squamous cell carcinomas (63/195, 32.3%). The en bloc, R0 and curative resection rates were 100% (195/195), 78.5% (153/195) and 67.2% (131/195), respectively. The mean rate of ESD was 29.7 mm2/min. One (0.5%) perprocedural perforation and 7 (3.6%) postprocedural bleedings occurred, all managed endoscopically. No delayed perforation occurred. Overall, 31 patients (31/195; 15.9%) of patients developed stenosis. CONCLUSIONS: The "tunnel + clip" strategy is safe, and allows to achieve high en bloc, R0 and curative resection rates. This standardized procedure could be used by physicians with little experience and might help spreading esophageal ESD in Western countries.

Impact of antibiotic prophylaxis and conditioning modalities in per-oral endoscopic myotomy for esophageal motor disorders.

BACKGROUND AND AIMS: No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate their impact on the POEM's safety. PATIENTS AND METHODS: This study was a comparative and multicentric retrospective analysis of a database prospectively collected. Patients over 18 years old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of adverse events, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered. RESULTS: A total of 226 patients (median age 52.9 ± 19.12 years [18-105], 116 women [51.3%]) were included. The indication for POEM was mainly type 2 achalasia (n = 135, 60.3%). Antibiotic prophylaxis was administered to 170 patients (75.2%) during 3.93 ± 3.46 days [1-21]. The overall adverse events rate was 9.3% (n = 21). Antibiotic prophylaxis was associated with the occurrence of adverse events (p = .003), but had no impact on their severity (p = .238). Antibiotic prophylaxis didn't influence the effectiveness of POEM (1 [0-4] vs 1 [0-9], p = .231). The use of a liquid diet in the 48 h prior to the procedure was significantly associated with a lower adverse events rate (3.1% vs 6.19%, p = .0002). CONCLUSION: The antibiotic prophylaxis during POEM does not prevent adverse events, had no impact on their severity and the efficacy of the procedure. A liquid diet before the procedure should be systematically proposed.

Digestive perforations related to endoscopy procedures: a local management charter based on local evidence and experts' opinion.

Background and study aims Perforations are a known adverse event of endoscopy procedures; a proposal for appropriate management should be available in each center as recommended by the European Society of Gastrointestinal Endoscopy. The objective of this study was to establish a charter for the management of endoscopic perforations, based on local evidence. Patients and methods Patients were included if they experienced partial or complete perforation during an endoscopic procedure between 2008 and 2018 (retrospectively until 2016, then prospectively). Perforations (size, location, closure) and management (imagery, antibiotics, surgery) were analyzed. Using these results, a panel of experts was asked to propose a consensual management charter. Results A total of 105 patients were included. Perforations occurred mainly during therapeutic procedures (91, 86.7%). Of the perforations, 78 (74.3 %) were diagnosed immediately and managed during the procedure; 69 of 78 (88.5 %) were successfully closed. Closures were more effective during therapeutic procedures (60 of 66, 90.9 %) than during diagnostic procedures (9 of 12, 75.0 %, P  = 0.06). Endoscopic closure was effective for 37 of 38 perforations (97.4 %) < 0.5 cm, and for 26 of 34 perforations (76.5 %) ≥ 0.5 cm ( P  < 0.05). For perforations < 0.5 cm, systematic computed tomography (CT) scan, antibiotics, or surgical evaluation did not improve the outcome. Four of 105 deaths (3.8 %) occurred after perforation, one of which was attributable to the perforation itself. Conclusions Detection and closure of perforations during endoscopic procedure had a better outcome compared to delayed perforations; perforations < 0.5 cm had a very good prognosis and CT scan, surgeon evaluation, or antibiotics are probably not necessary when the endoscopic closure is confidently performed. This work led to proposal of a local management charter.

Endoscopic characterization of colorectal neoplasia with different published classifications: comparative study involving CONECCT classification.

Background and study aims The aim of this study was to validate the COlorectal NEoplasia Classification to Choose the Treatment (CONECCT) classification that groups all published criteria (including covert signs of carcinoma) in a single table. Patients and methods For this multicenter comparative study an expert endoscopist created an image library (n = 206 lesions; from hyperplastic to deep invasive cancers) with at least white light Imaging and chromoendoscopy images (virtual ± dye based). Lesions were resected/biopsied to assess histology. Participants characterized lesions using the Paris, Laterally Spreading Tumours, Kudo, Sano, NBI International Colorectal Endoscopic Classification (NICE), Workgroup serrAted polypS and Polyposis (WASP), and CONECCT classifications, and assessed the quality of images on a web-based platform. Krippendorff alpha and Cohen's Kappa were used to assess interobserver and intra-observer agreement, respectively. Answers were cross-referenced with histology. Results Eleven experts, 19 non-experts, and 10 gastroenterology fellows participated. The CONECCT classification had a higher interobserver agreement (Krippendorff alpha = 0.738) than for all the other classifications and increased with expertise and with quality of pictures. CONECCT classification had a higher intra-observer agreement than all other existing classifications except WASP (only describing Sessile Serrated Adenoma Polyp). Specificity of CONECCT IIA (89.2, 95 % CI [80.4;94.9]) to diagnose adenomas was higher than the NICE2 category (71.1, 95 % CI [60.1;80.5]). The sensitivity of Kudo Vi, Sano IIIa, NICE 2 and CONECCT IIC to detect adenocarcinoma were statistically different ( P  < 0.001): the highest sensitivities were for NICE 2 (84.2 %) and CONECCT IIC (78.9 %), and the lowest for Kudo Vi (31.6 %). Conclusions The CONECCT classification currently offers the best interobserver and intra-observer agreement, including between experts and non-experts. CONECCT IIA is the best classification for excluding presence of adenocarcinoma in a colorectal lesion and CONECCT IIC offers the better compromise for diagnosing superficial adenocarcinoma.

The COlorectal NEoplasia Endoscopic Classification to Choose the Treatment classification for identification of large laterally spreading lesions lacking submucosal carcinomas: A prospective study of 663 lesions.

INTRODUCTION: Optical diagnosis is necessary when selecting the resection modality for large superficial colorectal lesions. The COlorectal NEoplasia Endoscopic Classification to Choose the Treatment (CONECCT) encompasses overt (irregular pit or vascular pattern) and covert (macroscopic features) signs of carcinoma in an all-in-one classification using validated criteria. The CONECCT IIC subtype corresponds to adenomas with a high risk of superficial carcinoma that should be resected en bloc with free margins. METHODS: This prospective multicentre study investigated the diagnostic accuracy of the CONECCT classification for predicting submucosal invasion in colorectal lesions >20 mm. Optical diagnosis before en bloc resection by endoscopic submucosal dissection (ESD) was compared with the final histological diagnosis. Diagnostic accuracy for the CONECCT IIC subtype was compared with literature-validated features of concern considered to be risk factors for submucosal invasion (non-granular large spreading tumour [NG LST], macronodule >1 cm, SANO IIIA area, and Paris 0-IIC area). RESULTS: Six hundred 63 lesions removed by ESD were assessed. The en bloc, R0, and curative resection rates were respectively 96%, 85%, and 81%. The CONECCT classification had a sensitivity (Se) of 100%, specificity (Sp) of 26.2%, positive predictive value of 11.6%, and negative predictive value (NPV) of 100% for predicting at least submucosal adenocarcinoma. The sensitivity of CONECCT IIC (100%) to predict submucosal cancer was superior to all other criteria evaluated. COlorectal NEoplasia Endoscopic Classification to Choose the Treatment IIC lesions constituted 11.5% of all submucosal carcinomas. CONCLUSION: The CONECCT classification, which combines covert and overt signs of carcinoma, identifies with very perfect sensitivity (Se 100%, NPV 100%) the 30% of low-risk adenomas in large laterally spreading lesions treatable by piecemeal endoscopic mucosal resection or ESD according to expertise without undertreatment. However, the low specificity of CONECCT leads to a large number of potentially not indicated ESDs for suspected high-risk lesions.