The investigation of prophylactic clip hemorrhage control for colorectal cold snare polypectomy in patients taking anti-thrombotic drugs.

JRCT ID: jRCT1032230086

Registered date:23/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal adenoma
• Date of first enrollment: 21/06/2023
• Target sample size: 574
• Study type: Interventional
• Intervention(s): Patients who meet the inclusion criteria and do not meet the exclusion criteria are randomly assigned 1:1 to the clip closure group or the non-clip closure group. Hematochezia will be evaluated in a patient diary for 2 weeks after the cold snare polypectomy.

Outcome(s)

• Primary Outcome: Percentage of delayed bleeding within 2 weeks after CSP (per patient). Delayed bleeding is defined as hematochezia requiring endoscopic hemostasis within 2 weeks after CSP.

Secondary Outcome

Secondary efficacy endpoints
1. rate of hematochezia within 2 weeks after CSP (per patient)
2. rate of delayed bleeding within 2 weeks after CSP (per polyp)
3. percentage of endoscopic procedures for hematochezia within 2 weeks after CSP (by patient and polyp).
4. treatment time (by patient and polyp).
Treatment time (from magnification of the first polyp to clip suture of the last polyp in the sutured group and to observation after resection in the non-sutured group).

Secondary safety endpoints
Complication rates (immediate bleeding, intraoperative perforation, delayed perforation, and post polypectomy syndrome)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. taking anti-thrombotic medication
2. 20 years of age or older at the time of consent (regardless of gender)
3. consent to participate in this study
4. have a preoperative suspected adenoma (including SSL) with endoscopic diameter < 10 mm and an indication for CSP (up to 10 lesions per patient)
5. more than 4 weeks interval from endoscopic polypectomy (CSP, EMR, ESD, etc.) in the colon
6. able to respond to antithrombotic drugs according to the guidelines.

Exclude criteria

1. gastrointestinal polyposis (e.g. familial adenomatous polyposis of the colon [FAP], but Lynch syndrome [HNPCC] is not excluded)
2. inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)
3. lesions with obvious fibrosis (including post-treatment recurrence)
4. tumors with preoperative suspicion of cancer
5. lesions with stoke
6. patients undergoing endoscopic treatment other than CSP at the same time
7. pregnant
8. patients on dialysis or with cirrhosis of the liver
9. patients with American Society of Anesthesiologists Class IV or higher (Patients with severe life-threatening systemic diseases)
10. platelet and coagulation factor dysfunction (e.g., hemophilia)
11. patients taking more than 3 antithrombotic drugs
12. other patients deemed ineligible by the physician in charge

Related Information

• Primary Sponsor: Okimoto Kenichiro
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)