colorectal adenoma colorectal CPS clip
Conditions
Interventions
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 p
CSP clip Antithrombotics
Sponsors
Matsumura Tomoaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactKenichiro Okimoto
Chiba University Hospital
Outcome results
None listed