Tokyo, Aug. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058742) titled 'A multicenter randomized controlled trial of post-ESD coagulation syndrome after colorectal endoscopic submucosal dissection' on Aug. 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Department of Endoscopy, NHO Kure Medical Center and Chugoku Cancer Center

Condition: Condition - Colorectal tumors 20mm - 50mm in diameter Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety and efficacy of early initiation of diet with that of normal initiation of diet after colorectal ESD Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Group A: normal initiation group Interventions/Control_2 - Group B: early initiation group

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients 1. with colorectal tumors measuring 20 - 50 mm in diameter considered difficult to remove en bloc with endoscopic mucosal resection, 2. aged 20 - 90 years at the time of obtaining informed consent, 3. with Eastern Cooperative Oncology Group performance status of 0 - 2, 4. with antithrombotic drug management according to the Japanese Guidelines for Gastroenterological Endoscopy, 5. who provided written informed consent to participate in the study. Key exclusion criteria - Patients with 1. colorectal tumors diagnosed as T1b cancer endospically, 2. colorectal tumors with local recurrence after endoscopic resection, 3. inflammatory bowel disease or familial adenomatous polyposis 4. a history of thrombocytopenia, coagulation system abnormalities, or bleeding tendency, 5. confirmed or possible pregnancy, 6. who have already enrolled in this study 7. unsuitable for clinical trial judged by clinicians Target Size - 320

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 08 Day Anticipated trial start date - 2025 Year 09 Month 01 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067165

Disclaimer: Curated by HT Syndication.