Adverse events of endoscopic full-thickness resection:results from the German and Dutch nationwide colorectal FTRD registry

Background and Aims: Endoscopic full-thickness resection (eFTR) is emerging as a minimally invasive alternative to surgery for complex colorectal lesions. Previous studies have demonstrated favorable safety results; however, large studies representing a generalizable estimation of adverse events (AEs) are lacking. Our aim was to provide further insight in AEs after eFTR.Methods: Data from all registered eFTR procedures in the German and Dutch colorectal full-thickness resection device registries between July 2015 and March 2021 were collected. Safety outcomes included immediate and late AEs.Results: Of 1892 procedures, the overall AE rate was 11.3% (213/1892). No AE-related mortality occurred. Perforations occurred in 2.5% (47/1892) of all AEs, 57.4% (27/47) of immediate AEs, and 42.6% (20/47) of delayed AEs. Successful endoscopic closure was achieved in 29.8% of cases (13 immediate and 1 delayed), and antibiotic treatment was sufficient in 4.3% (2 delayed). The appendicitis rate for appendiceal lesions was 9.9% (13/131), and 46.2% (6/13) could be treated conservatively. The severe AE rate requiring surgery was 2.2% (42/1892), including delayed perforations in .9% (17/1892) and immediate perforations in .7% (13/1892). Delayed perforations occurred between days 1 and 10 (median, 2) after eFTR, and 58.8% (10/17) were located on the left side. Other severe AEs were appendicitis (.4%, 7/1892), luminal stenosis (.1%, 2/1892), delayed bleeding (.1%, 1/1892), pain after eFTR close to the dentate line (.1%, 1/1892), and grasper entrapment in the clip (.1%, 1/1892).Conclusions: Colorectal eFTR is a safe procedure with a low risk for severe AEs in everyday practice and without AE-related mortality. These results further support the position of eFTR as an established minimally invasive technique for complex colorectal lesions.</p

Endoscopic full-thickness resection of T1 colorectal cancers:a retrospective analysis from a multicenter Dutch eFTR registry

Background Complete endoscopic resection and accurate histological evaluation for T1 colorectal cancer (CRC) are critical in determining subsequent treatment. Endoscopic full-thickness resection (eFTR) is a new treatment option for T1 CRC<2cm. We aimed to report clinical outcomes and short-term results. Methods Consecutive eFTR procedures for T1 CRC, prospectively recorded in our national registry between November 2015 and April 2020, were retrospectively analyzed. Primary outcomes were technical success and R0 resection. Secondary outcomes were histological risk assessment, curative resection, adverse events, and short-term outcomes. Results We included 330 procedures: 132 primary resections and 198 secondary scar resections after incomplete T1 CRC resection. Overall technical success, R0 resection, and curative resection rates were 87.0% (95% confidence interval [CI] 82.7%-90.3%), 85.6% (95%CI 81.2%-89.2%), and 60.3% (95%CI 54.7%-65.7%). Curative resection rate was 23.7% (95%CI 15.9%-33.6%) for primary resection of T1 CRC and 60.8% (95%CI 50.4%-70.4%) after excluding deep submucosal invasion as a risk factor. Risk stratification was possible in 99.3%. The severe adverse event rate was 2.2%. Additional oncological surgery was performed in 49/320 (15.3%), with residual cancer in 11/49 (22.4%). Endoscopic follow-up was available in 200/242 (82.6%), with a median of 4 months and residual cancer in 1 (0.5%) following an incomplete resection. Conclusions eFTR is relatively safe and effective for resection of small T1 CRC, both as primary and secondary treatment. eFTR can expand endoscopic treatment options for T1 CRC and could help to reduce surgical overtreatment. Future studies should focus on long-term outcomes

Te veel operaties voor benigne darmpoliepen

Colorectal cancer usually starts as a benign polyp. Endoscopic removal of these polyps reduces the risk of death from colorectal cancer. Some of the colorectal polyps are seen as 'too complex for endoscopic removal' and these polyps can be surgically resected. However, surgical resection is associated with higher morbidity and mortality. We have various advanced endoscopic techniques at our disposal for removing benign polyps these days, even if they are complex. The number of surgical resections of benign polyps is nevertheless increasing in the Netherlands, partly as a result of the introduction of population screening for colorectal cancer. Only a small proportion of patients with complex polyps is referred to a centre of expertise to undergo advanced endoscopic resection. We believe that regional multidisciplinary expert panels can improve the quality of care for patients with complex polyps and reduce the number of unnecessary surgical resections

Ervaringen met endoscopische ‘full-thickness’-resectie van colorectale afwijkingen

Endoscopic full-thickness resection (eFTR) is a minimally invasive resection technique that allows definite diagnosis and treatment for complex colorectal lesions unsuitable to conventional endoscopic resection. With the advantage of enabling a transmural resection, eFTR offers an alternative to radical surgery. Since the introduction of the full-thickness resection device in 2015, a nationwide prospective registry of consecutive eFTR procedures for all indications was initiated in the Netherlands, aiming to monitor patient outcomes and increase further knowledge on its clinical applicability and safety. Data show that eFTR is clinically feasible and relatively safe for complex colorectal lesions. Furthermore, eFTR is gaining interest as a diagnostic and therapeutic treatment option for T1 colorectal cancer

Novel classification for adverse events in GI endoscopy: the AGREE classification

Background and Aims: Standardized registration and evaluation of adverse events (AEs) are essential to assess the safety of endoscopic procedures. We propose a novel classification system, named adverse events in GI endoscopy (AGREE), adapted from a widely accepted surgical tool. Methods: The Clavien-Dindo classification for surgical AEs was adapted for endoscopy. To validate the novel classification, we assessed if the severity of AEs, as perceived by 10 endoscopists, 10 endoscopy nurses, and 10 patients, corresponded with the severity grading used in the AGREE classification in 10 pairwise comparisons. We additionally assessed the correlation between the AGREE classification and the American Society for Gastrointestinal Endoscopy (ASGE) classification. The acceptability of the AGREE classification was evaluated through an international questionnaire. Results: The perception of endoscopists, endoscopy nurses, and patients corresponded with the severity grading of the AGREE classification in 80% of cases (238/299). The AGREE classification significantly correlated with the ASGE classification (ρ = .760). Fifty-seven of 84 experts (68%) completed a questionnaire regarding the acceptability of the AGREE classification. The experts consulted considered the AGREE classification as simple (86%), reproducible (98%), logical (98%), and useful (96%). Most case presentations (84%) were correctly graded according to the AGREE classification. Conclusions: The AGREE classification provides a standardized and reproducible approach to the assessment of AEs in diagnostic and therapeutic GI endoscopy. Broad implementation of the AGREE classification may facilitate the evaluation of AEs across different endoscopists, disciplines, endoscopy services, and regions. This standardization of AE reporting will support improved quality assurance in GI endoscopy

Deep submucosal invasion is not an independent risk factor for lymph node metastasis in T1 colorectal cancer: a meta-analysis

Background &amp; aims: Deep submucosal invasion (DSI) is considered a key risk factor for lymph node metastasis (LNM) and important criterion to recommend surgery in T1 colorectal cancer (CRC). However, metastatic risk for DSI is shown to be low in absence of other histological risk factors. This meta-analysis determines the independent risk of DSI for LNM. Methods: Suitable studies were included to establish LNM-risk for DSI in univariable analysis. To assess DSI as independent risk factor, studies were eligible if 1) risk factors (DSI, poor differentiation (PD), lymphovascular invasion (LVI) and/or high-grade tumor budding (TB)) were simultaneously included in multivariable analysis or 2) LNM-rate of DSI was described in absence of PD, LVI and TB. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. Results: Sixty-seven studies (21,238 patients) were included. Overall LNM-rate was 11.2% and significantly higher for DSI-positive cancers (OR 2.58;95%CI2.10-3.18). Eight studies (3621 patients) were included in multivariable meta-analysis and did not weigh DSI a significant predictor for LNM (OR 1.73;95%CI0.96-3.12). As opposed to a significant association between LNM and PD (OR 2.14;95%CI 1.39-3.28), TB (OR 2.83;95%CI2.06-3.88) and LVI (OR 3.16;95%CI1.88-5.33). Eight studies (1146 patients) analyzed DSI as solitary risk factor: absolute risk of LNM was 2.6% and pooled incidence rate 2.83 (95%CI1.66-4.78). Conclusions: DSI is not a strong independent predictor for LNM and should be reconsidered as a sole indicator for oncologic surgery. The expanding armamentarium for local excision as first-line treatment prompts serious consideration in amenable cases to tailor T1 CRC management