Clinical Trial: Prospective multicenter single-arm study evaluating the efficacy of a standardized management strategy using the reopenable-clip over-the-line method (ROLM) for mucosal defects after gastric endoscopic submucosal dissection in high-risk patients (Japan)

Tokyo, June 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061838) titled 'Prospective multicenter single-arm study evaluating the efficacy of a standardized management strategy using the reopenable-clip over-the-line method (ROLM) for mucosal defects after gastric endoscopic submucosal dissection in high-risk patients' on June 9.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Suzuka General Hospital

Condition: Condition - Post-ESD mucosal defects in high-risk patients undergoing gastric endoscopic submucosal dissection Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate whether a standardized management strategy using the reopenable-clip over-the-line method (ROLM) can achieve a predefined performance goal for clinically significant delayed bleeding within 30 days after gastric endoscopic submucosal dissection in high-risk patients. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Closure of post-ESD mucosal defects in high-risk patients (BEST-J score >= 3). After gastric ESD, all patients undergo defect closure using the reopenable-clip over-the-line method (ROLM). Perioperative management is performed according to the predefined study protocol.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients aged 20 years or older at the time of informed consent 2. Patients undergoing gastric endoscopic submucosal dissection (ESD) for gastric neoplasms 3. Patients with post-ESD mucosal defects considered amenable to closure using the reopenable-clip over-the-line method (ROLM) 4. BEST-J score >= 3 5. Written informed consent obtained Key exclusion criteria - 1. Lesions involving the cardia or pylorus where ROLM is considered technically difficult 2. Mucosal defects involving more than 50% of the gastric circumference 3. Severe fibrosis or poor general condition preventing completion of the study procedure 4. Cases requiring emergency surgery, such as perforation requiring immediate lifesaving treatment 5. Pregnant women or women with possible pregnancy 6. Any patient considered unsuitable for study participation by the principal investigator Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 04 Day Date of IRB - 2026 Year 06 Month 04 Day Anticipated trial start date - 2026 Year 06 Month 10 Day Last follow-up date - 2029 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070762

Disclaimer: Curated by HT Syndication.