Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061924) titled 'Multicenter Observational Study Evaluating the Feasibility and Safety of Clinical Introduction of Endoscopic Hand Suturing Following Standardized Training' on June 30.

Study Type: Observational

Primary Sponsor: Institute - Omuta city hospital

Condition: Condition - Early Gastric Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the clinical feasibility and safety of Endoscopic Hand Suturing (EHS) in clinical cases after the implementation of a standardized EHS training system. The primary endpoint is the completion rate of EHS. Secondary endpoints include suturing time, number of stitches, suturing time per stitch, sustained closure rate, post-procedural bleeding rate, complication rate, adverse event rate, and location-specific technical difficulty. Basic objectives2 - Safety

Eligibility: Age-lower limit - 20 years-old =20 years

4.ECOG performance status 0-1

5.Written informed consent obtained from the patient Key exclusion criteria - 1.Early gastric cancer arising in the remnant stomach after gastrectomy (including remnant gastric cancer and gastric conduit cancer)

2.Tumors adjacent to the cardia or pylorus, or crossing the gastric angle

3.Bleeding tendency defined as platelet count =2 (excluding patients receiving warfarin therapy)

4.Liver cirrhosis classified as Child-Pugh class B or C

5.Chronic renal failure requiring maintenance dialysis

6.Any cases deemed inappropriate for study participation by the investigators Target Size - 60

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 03 Month 01 Day Date of IRB - 2024 Year 03 Month 01 Day Anticipated trial start date - 2024 Year 03 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069512

Disclaimer: Curated by HT Syndication.