Comprehensive Analysis of Adverse Events Associated with Gastric Peroral Endoscopic Myotomy: An International Multicenter Study.

BACKGROUND: Gastric peroral endoscopic myotomy (G-POEM) has emerged as an effective management approach for patients with refractory gastroparesis. This study aims to comprehensively study the safety of G-POEM and describe the predictive factors of adverse events (AEs) occurrence. METHODS: This study is a retrospective study involving 13 tertiary care centers (7 USA, 1 South America, 4 Europe, and 1 Asia). Patients who underwent G-POEM for refractory gastroparesis were included. Cases were identified by the occurrence of AEs. For each case, two controls were randomly selected and matched for age (± 10 years), gender, and etiology of gastroparesis. RESULTS: A total of 216 patients underwent G-POEM for gastroparesis. Overall, 31 (14%) AEs were encountered [mild 24 (77%), moderate 5 (16%), and severe 2 (6%)] during the duration of the study. The most common AE was abdominal pain (n = 16), followed by mucosotomy (n = 5) and capnoperitoneum (n = 4), and AEs were most commonly identified within the first 48-h post-procedure 18 (58%). The risk of adverse event occurrence was significantly higher for endoscopists with experience of < 20 G-POEM procedures (OR 3.03 [1.03-8.94], p < 0.05). CONCLUSION: G-POEM seems to be a safe intervention for refractory gastroparesis. AEs are most commonly mild and managed conservatively. Longitudinal mucosal incision, use of hook knife, use of clips for mucosal closure and endoscopist's experience with > 20 G-POEM procedures is significantly associated with decreased incidence of AEs.

A large multicenter cohort on the use of full-thickness resection device for difficult colonic lesions.

BACKGROUND: Introduction of the full-thickness resection device (FTRD) has allowed endoscopic resection of difficult lesions such as those with deep wall origin/infiltration or those located in difficult anatomic locations. The aim of this study is to assess the outcomes of the FTRD among its early users in the USA. METHODS: Patients who underwent endoscopic full-thickness resection (EFTR) for lower gastrointestinal tract lesions using the FTRD at 26 US tertiary care centers between 10/2017 and 12/2018 were included. Primary outcome was R0 resection rate. Secondary outcomes included rate of technical success (en bloc resection), achievement of histologic full-thickness resection (FTR), and adverse events (AE). RESULTS: A total of 95 patients (mean age 65.5 ± 12.6 year, 38.9% F) were included. The most common indication, for use of FTRD, was resection of difficult adenomas (non-lifting, recurrent, residual, or involving appendiceal orifice/diverticular opening) (66.3%), followed by adenocarcinomas (22.1%), and subepithelial tumors (SET) (11.6%). Lesions were located in the proximal colon (61.1%), distal colon (18.9%), or rectum (20%). Mean lesion diameter was 15.5 ± 6.4 mm and 61.1% had a prior resection attempt. The mean total procedure time was 59.7 ± 31.8 min. R0 resection was achieved in 82.7% while technical success was achieved in 84.2%. Histologically FTR was demonstrated in 88.1% of patients. There were five clinical AE (5.3%) with 2 (2.1%) requiring surgical intervention. CONCLUSIONS: Results from this first US multicenter study suggest that EFTR with the FTRD is a technically feasible, safe, and effective technique for resecting difficult colonic lesions.