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.

Systematic Resection of the Visible Scar After Incomplete Endoscopic Resection of Rectal Neuroendocrine Tumors.

INTRODUCTION: When initial resection of rectal neuroendocrine tumors (r-NETs) is not R0, persistence of local residue could lead to disease recurrence. This study aimed to evaluate the interest of systematic resection of non-R0 r-NET scars. METHODS: Retrospective analysis of all the consecutive endoscopic revisions and resections of the scar after non-R0 resections of r-NETs. RESULTS: A total of 100 patients were included. Salvage endoscopic procedure using endoscopic submucosal dissection or endoscopic full-thickness resection showed an R0 rate of near 100%. Residual r-NET was found in 43% of cases. DISCUSSION: In case of non-R0 resected r-NET, systematic scar resection by endoscopic full-thickness resection or endoscopic submucosal dissection seems necessary.

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.

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 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.

Prevalence and clinical significance of the muscle retracting sign during endoscopic submucosal dissection of large macronodular colorectal lesions (with videos).

BACKGROUND AND AIMS: The muscle retracting sign (MRS) can be present during endoscopic submucosal dissection (ESD) of macronodular colorectal lesions. The prevalence of MRS and its pathologic and clinical implications is unclear. This study evaluated the effect of MRS on the technical and clinical outcomes of ESD. METHODS: All patients referred for ESD of protruding lesions or granular mixed lesions with >10 mm macronodule granular mixed laterally spreading tumors (LST-GMs) in 2 academic centers from January 2017 to October 2022 were prospectively included. Size of the macronodule was analyzed retrospectively. The primary outcome was the curative resection rate according to MRS status. Secondary outcomes were R0 resection, perforation, secondary surgery rate, and risk factors for MRS. RESULTS: Of 694 lesions, 84 (12%) had MRS (MRS+). The curative resection rate was decreased by MRS (MRS+ 41.6% vs lesions without MRS [MRS-] 81.3%), whereas the perforation (MRS+ 22.6% vs MRS- 9.2%), submucosal cancer (MRS+ 34.9% vs MRS- 9.2%), and surgery (MRS+ 45.2% vs MRS- 6%) rates were increased. The R0 resection rate of MRS+ colonic lesions was lower than that of rectal lesions (53% vs 74.3%). In multivariate analysis, protruding lesions (odds ratio, 2.47; 95% confidence interval, 1.27-4.80) and macronodules >4 cm (odds ratio, 4.24; 95% confidence interval, 2.23-8.05) were risk factors for MRS. CONCLUSIONS: MRS reduces oncologic outcomes and increases the perforation rate. Consequently, procedures in the colon should be stopped if MRS is detected, and those in the rectum should be continued due to the morbidity of alternative therapy.

Impact of surgery after endoscopically resected high-risk T1 colorectal cancer: results of an emulated target trial.

BACKGROUND AND AIMS: We aimed to compare the long-term outcomes of patients with high-risk T1 colorectal cancer (CRC) resected endoscopically who received either additional surgery or surveillance. METHODS: We used data from routine care to emulate a target trial aimed at comparing 2 strategies after endoscopic resection of high-risk T1 CRC: surgery with lymph node dissection (treatment group) versus surveillance alone (control group). All patients from 14 tertiary centers who underwent an endoscopic resection for high-risk T1 CRC between March 2012 and August 2019 were included. The primary outcome was a composite outcome of cancer recurrence or death at 48 months. RESULTS: Of 197 patients included in the analysis, 107 were categorized in the treatment group and 90 were categorized in the control group. From baseline to 48 months, 4 of 107 patients (3.7%) died in the treatment group and 6 of 90 patients (6.7%) died in the control group. Four of 107 patients (3.7%) in the treatment group experienced a cancer recurrence and 4 of 90 patients (4.4%) in the control group experienced a cancer recurrence. After balancing the baseline covariates by inverse probability of treatment weighting, we found no significant difference in the rate of death and cancer recurrence between patients in the 2 groups (weighted hazard ratio, .95; 95% confidence interval, .52-1.75). CONCLUSIONS: Our study suggests that patients with high-risk T1 CRC initially treated with endoscopic resection may not benefit from additional surgery.

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 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.

Traction-assisted endoscopic submucosal dissection for resection of ileocecal valve neoplasia: a French retrospective multicenter case series.

BACKGROUND: The ileocecal valve (ICV) is considered to be one of the most difficult locations for endoscopic submucosal dissection (ESD). The objective of this study was to evaluate the efficacy and safety of traction-assisted ESD in this situation. METHODS: All patients who underwent traction-assisted ESD for an ICV lesion at three centers were identified from a prospective ESD database. En bloc and R0 rates were evaluated. Factors associated with non-R0 resection were explored. RESULTS: 106 patients with an ICV lesion were included. The median lesion size was 50 mm (interquartile range 38-60) and 58.5% (62/106) invaded the terminal ileum. The en bloc and R0 resection rates were 94.3% and 76.4%, respectively. Factors associated with non-R0 resection were lesions covering ≥75% of the ICV (odds ratio [OR] 0.21. 95%CI 0.06-0.76; P=0.02), and involving the anal lip (OR 0.36, 95%CI 0.13-0.99; P=0.04) or more than two sites on the ICV (OR 0.27, 95%CI 0.07-0.99; P=0.03). CONCLUSION: Traction-assisted ESD for treatment of ICV lesions was a safe and feasible option. Large lesions and anal lip involvement appeared to be factors predictive of difficulty.

The environmental impact of small-bowel capsule endoscopy.

INTRODUCTION: The environmental impact of endoscopy, including small-bowel capsule endoscopy (SBCE), is a topic of growing attention and concern. This study aimed to evaluate the greenhouse gas (GHG) emissions (kgCO2) generated by an SBCE procedure. METHODS: Life cycle assessment methodology (ISO 14040) was used to evaluate three brands of SBCE device and included emissions generated by patient travel, bowel preparation, capsule examination, and video recording. A survey of 87 physicians and 120 patients was conducted to obtain data on travel, activities undertaken during the procedure, and awareness of environmental impacts. RESULTS: The capsule itself (4 g) accounted for < 6 % of the total product weight. Packaging (43-119 g) accounted for 9 %-97 % of total weight, and included deactivation magnets (5 g [4 %-6 %]) and paper instructions (11-50 g [up to 40 %]). A full SBCE procedure generated approximately 20 kgCO2, with 0.04 kgCO2 (0.2 %) attributable to the capsule itself and 18 kgCO2 (94.7 %) generated by patient travel. Capsule retrieval using a dedicated device would add 0.98 kgCO2 to the carbon footprint. Capsule deconstruction revealed materials (e. g. neodymium) that are prohibited from environmental disposal; 76 % of patients were not aware of the illegal nature of capsule disposal via wastewater, and 63 % would have been willing to retrieve it. The carbon impact of data storage and capsule reading was negligible. CONCLUSION: The carbon footprint of SBCE is mainly determined by patient travel. The capsule device itself has a relatively low carbon footprint. Given that disposal of capsule components via wastewater is illegal, retrieval of the capsule is necessary but would likely be associated with an increase in device-related emissions.

Endoscopic submucosal dissection of appendicular lesions is feasible and safe: a retrospective multicenter study (with video).

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is challenging for appendicular lesions. We report the outcomes of ESD in this context. METHODS: We collected data of ESD procedures for appendiceal neoplasia in a multicenter prospective registry. Main study endpoints were R0, en-bloc, and curative resection rates and adverse event rate. RESULTS: One hundred twelve patients were included, 47 (42%) with previous appendectomy. Fifty-six (50%) were Toyonaga type 3 lesions (15 [13.4%] postappendectomy). En-bloc and R0 resection rates were 86.6% and 80.4%, respectively, with no significant difference associated with different grades of appendiceal invasion (P = .9 and P = .4, respectively) or previous appendectomy (P = .3 for both). The curative resection rate was 78.6%. Additional surgery was performed in 16 cases (14.3%), including 10 (62.5%) Toyonaga type 3 lesions (P = .04). This included the treatment of 5 cases (4.5%) of delayed perforation and 1 acute appendicitis. CONCLUSIONS: ESD for appendicular lesions is a potentially safer and effective alternative to surgery for a significant proportion of patients.

Diagnostic endoscopic submucosal dissection for colorectal lesions with suspected deep invasion.

BACKGROUND: Endoscopic submucosal dissection (ESD) is potentially a curative treatment for T1 colorectal cancer under certain conditions. The aim of this study was to evaluate the feasibility and effectiveness of ESD for lesions with a suspicion of focal deep invasion. METHODS: In this retrospective multicenter study, consecutive patients with colorectal neoplasia displaying a focal (< 15 mm) deep invasive pattern (FDIP) that were treated by ESD were included. We excluded ulcerated lesions (Paris III), lesions with distant metastasis, and clearly advanced tumors (tumoral strictures). RESULTS: 124 patients benefited from 126 diagnostic dissection attempts for FDIP lesions. Dissection was feasible in 120/126 attempts (95.2 %) and, where possible, the en bloc and R0 resection rates were 95.8 % (115/120) and 76.7 % (92/120), respectively. Thirty-three resections (26.2 %) were for very low risk tumors, so considered curative, and 38 (30.2 %) were for low risk lesions. Noncurative R0 resections were for lesions with lymphatic or vascular invasion (LVI; n = 8), or significant budding (n = 9), and LVI + budding combination (n = 4). CONCLUSION: ESD is feasible and safe for colorectal lesions with an FDIP ≤ 15 mm. It was curative in 26.6 % of patients and could be a valid option for a further 30.6 % of patients with low risk T1 cancers, especially for frail patients with co-morbidities.

Multicenter randomized trial comparing diagnostic sensitivity and cellular abundance with aggressive versus standard biliary brushing for bile duct stenosis without mass syndrome.

BACKGROUND : The diagnosis of cholangiocarcinoma in patients with a biliary stricture without mass syndrome can be obtained by biliary brushing with a sensitivity of ~50 %. We performed a multicenter randomized crossover trial comparing the aggressive Infinity brush with the standard RX Cytology Brush. The aims were to compare sensitivity for cholangiocarcinoma diagnosis and cellularity obtained. METHODS : Biliary brushing was performed consecutively with each brush, in a randomized order. Cytological material was studied with blinding to the brush type used and order. The primary end point was sensitivity for cholangiocarcinoma diagnosis; the secondary end point was the abundance of cellularity obtained with each brush, with cellularity quantified in order to determine if one brush strongly outperformed the other. RESULTS : 51 patients were included. Final diagnoses were cholangiocarcinoma (n = 43; 84 %), benign (n = 7; 14 %), and indeterminate (n = 1; 2 %). Sensitivity for cholangiocarcinoma was 79 % (34 /43) for the Infinity brush versus 67 % (29/43) for the RX Cytology Brush (P = 0.10). Cellularity was rich in 31/51 cases (61 %) with the Infinity brush and in 10/51 cases (20 %) with the RX Cytology Brush (P < 0.001). In terms of quantification of cellularity, the Infinity brush strongly outperformed the RX Cytology Brush in 28/51 cases (55 %), while the RX Cytology Brush strongly outperformed the Infinity brush in 4/51 cases (8 %; P < 0.001). CONCLUSIONS : This randomized crossover trial showed that the Infinity brush is not significantly more effective than the RX Cytology Brush for biliary stenosis without mass syndrome in terms of sensitivity for cholangiocarcinoma diagnosis, but does offer a significantly higher abundance of cellularity.

Endoscopic resection of early esophageal tumors in patients with cirrhosis or portal hypertension: a multicenter observational study.

BACKGROUND: Liver cirrhosis and esophageal cancer share several risk factors, such as alcohol intake and excess weight. Endoscopic resection is the gold standard treatment for superficial tumors. Portal hypertension and coagulopathy may increase the bleeding risk in these patients. This study aimed to assess the safety and efficacy of endoscopic resection for early esophageal neoplasia in patients with cirrhosis or portal hypertension. METHODS: This retrospective multicenter international study included consecutive patients with cirrhosis or portal hypertension who underwent endoscopic resection in the esophagus from January 2005 to March 2021. RESULTS: 134 lesions in 112 patients were treated, including by endoscopic submucosal dissection in 101 cases (75 %). Most lesions (128/134, 96 %) were in patients with liver cirrhosis, with esophageal varices in 71 procedures. To prevent bleeding, 7 patients received a transjugular intrahepatic portosystemic shunt, 8 underwent endoscopic band ligation (EBL) before resection, 15 received vasoactive drugs, 8 received platelet transfusion, and 9 underwent EBL during the resection procedure. Rates of complete macroscopic resection, en bloc resection, and curative resection were 92 %, 86 %, and 63 %, respectively. Adverse events included 3 perforations, 8 delayed bleedings, 8 sepsis, 6 cirrhosis decompensations within 30 days, and 22 esophageal strictures; none required surgery. In univariate analysis, cap-assisted endoscopic mucosal resection was associated with delayed bleeding (P = 0.01). CONCLUSIONS: In patients with liver cirrhosis or portal hypertension, endoscopic resection of early esophageal neoplasia appeared to be effective and should be considered in expert centers with choice of resection technique, following European Society of Gastrointestinal Endoscopy guidelines to avoid undertreatment.

Use of endoscopic submucosal dissection or full-thickness resection device to treat residual colorectal neoplasia after endoscopic resection: a multicenter historical cohort study.

INTRODUCTION : Residual colorectal neoplasia (RCN) after previous endoscopic mucosal resection is a frequent challenge. Different management techniques are feasible including endoscopic full-thickness resection using the full-thickness resection device (FTRD) system and endoscopic submucosal dissection (ESD). We aimed to compare the efficacy and safety of these two techniques for the treatment of such lesions. METHODS : All consecutive patients with RCN treated either using the FTRD or by ESD were retrospectively included in this multicenter study. The primary outcome was the R0 resection rate, defined as an en bloc resection with histologically tumor-free lateral and deep margins. RESULTS : 275 patients (median age 70 years; 160 men) who underwent 177 ESD and 98 FTRD procedures for RCN were included. R0 resection was achieved in 83.3 % and 77.6 % for ESD and FTRD, respectively (P = 0.25). Lesions treated by ESD were however larger than those treated by FTRD (P < 0.001). The R0 rates for lesions of 20-30 mm were 83.9 % and 57.1 % in the ESD and FTRD groups, respectively, and for lesions of 30-40 mm were 93.6 % and 33.3 %, respectively. On multivariable analysis, ESD procedures were associated with statistically higher en bloc and R0 resection rates after adjustment for lesion size (P = 0.02 and P < 0.001, respectively). The adverse event rate was higher in the ESD group (16.3 % vs. 5.1 %), mostly owing to intraoperative perforations. CONCLUSION: ESD is effective in achieving R0 resection for RCN whatever the size and location of the lesions. When residual lesions are smaller than 20 mm, the FTRD is an effective alternative.

Peroral endoscopic myotomy: is it better to perform it in naive patients or as second-line therapy? Results of an open-label-controlled study in 105 patients.

BACKGROUND: Whether Peroral Endoscopic Myotomy (POEM) can be proposed as a second-line treatment in patients with achalasia remains to be confirmed in real-life series. OBJECTIVE: This study aimed to compare the efficacy, feasibility and safety of POEM between treatment-naïve patients and patients who had prior endoscopic or surgical therapies for achalasia. METHODS: All consecutive patients who underwent a POEM procedure for achalasia in our centre from June 2015 to September 2018 were included in this retrospective study. They were classified into treatment-naïve patients (POEM1) and patients who had at least one previous endoscopic and/or surgical treatment for achalasia (POEM2). RESULTS: A total of 105 patients were included, 52 in the POEM1 group and 53 in the POEM2 group. Clinical success (defined as an Eckardt score ≤ 3) at 6 months was observed in 93% of POEM1 patients and 84% of POEM2 patients (p = 0.18). Technical success rate was not significantly different between the two groups (100% vs 96%, respectively; p = 0.50). No significant difference was noted in terms of adverse event rate (19% vs 19%, respectively; p = 1.00). Post-procedure pain occurred in 12% of treatment-naive and 9% of non-naïve patients (p = 0.76). The median length of hospital stay was 3 days in both groups (p = 0.17). Symptomatic gastroesophageal reflux occurred in 25% of POEM1 patients and 16% of POEM2 patients (p = 0.24). CONCLUSION: Efficacy, feasibility and safety of POEM are not different between treatment-naïve and non-naïve patients. POEM is a valuable second-line approach in patients with persistent symptoms of achalasia after surgical or endoscopic treatments.

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.

Endoscopic submucosal dissection combined with clip for closure of gastrointestinal fistulas including those refractory to previous therapy.

BACKGROUND: Gastrointestinal (GI) fistula is a life-threatening condition and a therapeutic challenge. Endoscopic approaches include mucosal abrasion, clip closure, or stent diversion, with moderate success rates in the long term. We assessed whether fistula endoscopic submucosal dissection with clip closure (FESDC) could lead to complete resolution of fistulas even after failure of previous endoscopic therapy. METHODS: Patients with GI fistulas, including those with previous failed treatment, were retrospectively included. The primary outcome was long-term (> 3 months) success of fistula healing. Secondary outcomes included technical success, safety, and factors associated with FESDC success. RESULTS: 23 patients (13 refractory 57 %) were included. Tight immediate sealing was achieved in 19 patients (83 %; 95 % confidence interval [CI] 61 %-95 %). Long-term closure was achieved in 14 patients (61 %; 95 %CI 39 %-80 %), with median follow-up of 20 months. Complications occurred in two patients (9 %). Previous local malignancy (P = 0.08) and radiotherapy (P = 0.047) were associated with a higher risk of failure. CONCLUSION: This novel FESDC strategy was demonstrated to be safe and feasible for permanent endoscopic closure of GI fistulas. Further studies are warranted to determine the place of this technique in the management of chronic GI fistula.

One-year results of gastric peroral endoscopic myotomy for refractory gastroparesis: a French multicenter study.

BACKGROUND: Data on the long-term outcomes of gastric peroral endoscopic myotomy (G-POEM) for refractory gastroparesis are lacking. We report the results of a large multicenter long-term follow-up study of G-POEM for refractory gastroparesis. METHODS: This was a retrospective multicenter study of all G-POEM operations performed in seven expert French centers for refractory gastroparesis with at least 1 year of follow-up. The primary endpoint was the 1-year clinical success rate, defined as at least a 1-point improvement in the Gastroparesis Cardinal Symptom Index (GCSI). RESULTS: 76 patients were included (60.5 % women; age 56 years). The median symptom duration was 48 months. The median gastric retention at 4 hours (H4) before G-POEM was 45 % (interquartile range [IQR] 29 % - 67 %). The median GCSI before G-POEM was 3.6 (IQR 2.8 - 4.0). Clinical success was achieved in 65.8 % of the patients at 1 year, with a median rate of reduction in the GCSI score of 41 %. In logistic regression analysis, only a high preoperative GCSI satiety subscale score was predictive of clinical success (odds ratio [OR] 3.41, 95 % confidence interval [CI] 1.01 - 11.54; P = 0.048), while a high rate of gastric retention at H4 was significantly associated with clinical failure (OR 0.97, 95 %CI 0.95 - 1.00; P = 0.03). CONCLUSIONS: The results confirm the efficacy of G-POEM for the treatment of refractory gastroparesis, as evidenced by a 65.8 % clinical success rate at 1 year. Although G-POEM is promising, prospective sham-controlled trials are urgently needed to confirm its efficacy and identify the patient populations who will benefit most from this procedure.