BACKGROUND: The efficacy of routine second-look endoscopy (SLE) to detect or prevent bleeding after gastric endoscopic submucosal dissection (ESD) has not yet been validated. OBJECTIVE: The aim of this study was to determine whether SLE affects clinical outcomes including bleeding and morbidity after gastric ESD. DESIGN: A prospective, randomized, controlled study with consecutive data analyzed on an as-treated basis. SETTING: A single, tertiary-care referral center. PATIENTS: A total of 182 patients. INTERVENTION: Gastric ESD and SLE. MAIN OUTCOME MEASUREMENTS: Incidence of and risk factors related to bleeding after ESD and outcomes by univariate or multivariate analysis. RESULTS: Among 182 patients enrolled, 74 and 81 patients were assigned to the SLE and no-SLE groups, respectively. Two groups were observed closely for 4 weeks. Bleeding occurred after ESD in 21 patients (13.5%). Hemoglobin loss (≥2.0 g/dL) was observed in 20 patients, and melena developed in 1 patient after ESD. However, only 1 patient needed a transfusion. Twelve patients (16.2%) in the SLE group and 9 in the no-SLE group (11.1%) experienced bleeding after ESD. The frequency of bleeding after ESD was not significantly different between the 2 groups (P = .66). There were no risk factors related to bleeding after ESD. LIMITATIONS: Single-center analysis. CONCLUSION:SLE is not routinely necessary because it does not affect clinical outcomes, including bleeding and morbidity after ESD. ( CLINICAL TRIAL REGISTRATION NUMBER: KCT0000146.).
RCT Entities:
BACKGROUND: The efficacy of routine second-look endoscopy (SLE) to detect or prevent bleeding after gastric endoscopic submucosal dissection (ESD) has not yet been validated. OBJECTIVE: The aim of this study was to determine whether SLE affects clinical outcomes including bleeding and morbidity after gastric ESD. DESIGN: A prospective, randomized, controlled study with consecutive data analyzed on an as-treated basis. SETTING: A single, tertiary-care referral center. PATIENTS: A total of 182 patients. INTERVENTION: Gastric ESD and SLE. MAIN OUTCOME MEASUREMENTS: Incidence of and risk factors related to bleeding after ESD and outcomes by univariate or multivariate analysis. RESULTS: Among 182 patients enrolled, 74 and 81 patients were assigned to the SLE and no-SLE groups, respectively. Two groups were observed closely for 4 weeks. Bleeding occurred after ESD in 21 patients (13.5%). Hemoglobin loss (≥2.0 g/dL) was observed in 20 patients, and melena developed in 1 patient after ESD. However, only 1 patient needed a transfusion. Twelve patients (16.2%) in the SLE group and 9 in the no-SLE group (11.1%) experienced bleeding after ESD. The frequency of bleeding after ESD was not significantly different between the 2 groups (P = .66). There were no risk factors related to bleeding after ESD. LIMITATIONS: Single-center analysis. CONCLUSION:SLE is not routinely necessary because it does not affect clinical outcomes, including bleeding and morbidity after ESD. ( CLINICAL TRIAL REGISTRATION NUMBER: KCT0000146.).
Authors: Chan Hyuk Park; Dong-Hoon Yang; Jong Wook Kim; Jie-Hyun Kim; Ji Hyun Kim; Yang Won Min; Si Hyung Lee; Jung Ho Bae; Hyunsoo Chung; Kee Don Choi; Jun Chul Park; Hyuk Lee; Min-Seob Kwak; Bun Kim; Hyun Jung Lee; Hye Seung Lee; Miyoung Choi; Dong-Ah Park; Jong Yeul Lee; Jeong-Sik Byeon; Chan Guk Park; Joo Young Cho; Soo Teik Lee; Hoon Jai Chun Journal: Intest Res Date: 2020-10-13