Tokyo, May 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061720) titled 'Risk Assessment of Delayed Bleeding After Gastric Endoscopic Submucosal Dissection in Patients Receiving Anticoagulants and Validation of the Supplemented Guidelines for Gastrointestinal Endoscopy in Patients Undergoing Antithrombotic Therapy: A Multicenter Observational Study' on May 28.
Study Type:
Observational
Primary Sponsor:
Institute - National Hospital Organization Kyoto Medical Center
Condition:
Condition - Early gastric cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - When gastric ESD is performed in patients receiving DOACs according to the supplementary guidelines, the incidence of delayed gastrointestinal bleeding is expected to range from 8% to 15%. However, no large-scale multicenter study has validated the appropriateness of the supplementary guidelines. Therefore, evaluating both the safety and validity of guideline-based management strategies in patients receiving anticoagulants is an important clinical issue.In this study, we aimed to compare delayed bleeding rates before and after publication of the 2017 supplementary guidelines in patients receiving anticoagulants who underwent ESD according to the Japanese Gastric Cancer Association guidelines. We also aimed to evaluate the validity of management strategies based on the JGES supplementary guidelines for patients receiving antithrombotic therapy.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
20 years.
2. Underwent ESD for early gastric cancer according to the Japanese Gastric Cancer Treatment Guidelines.
3. Receiving anticoagulants (warfarin or DOACs).
4. Underwent ESD according to the JGES Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment or the supplementary edition.
Key exclusion criteria - 1. ESD discontinued due to complications (e.g., bleeding or perforation), technical difficulties, or conversion to surgical treatment.
2. Inability to complete follow-up for at least 28 days after ESD.
3. Additional photodynamic therapy (PDT) performed after ESD.
4. Histopathological evidence of invasion deeper than the muscularis propria.
5. Participation in another interventional study.
6. Refusal to allow use of clinical data.
Target Size - 1760
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2022 Year 10 Month 01 Day
Date of IRB - 2022 Year 12 Month 19 Day
Anticipated trial start date - 2022 Year 10 Month 01 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070635
Disclaimer: Curated by HT Syndication.
