Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Controlled Trial

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-12-31

Summary

Background Colonoscopy can detect colon polyps and perform excision to the polyps to prevent colon cancer. However, delayed polypectomy bleeding is one of the complications to be noticed, which has an occurrence rate of about 1-2%, especially large polyps over 1cm with hot snare polypectomy. Colonoscopic clipping was applied for the treatment of bleeding. However, prophylactic clipping after polypectomy was not proved to reduce the rate of delayed polypectomy bleeding. Sucralfate is used for peptic ulcer treatment, which can become a protective layer on the wound to prevent environmental injury. Our preliminary data revealed the endoscopic sucralfate spray could reduce the delayed bleeding rate among general populations. Whether sucralfate can prevent polypectomy wounds from delayed bleeding in high-risk polyps is unknown.

Aim This study aimed to compare the efficacy in reducing delayed bleeding rate between sucralfate administration and prophylactic clipping on high-risk polypectomy wounds.

Method This is a randomized clinical trial. The study will recruit 160 patients. After randomization, 80 patients will be classified into the Sucralfate group and 80 into the Clipping group. The participants will receive an endoscopic survey as routine, and we will enroll all patients who take antiplatelets or anticoagulants with polyp size 1 cm after hot snare polyp excision. Exclusion criteria include patients with an allergy to sucralfate. If immediate polypectomy bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine, heater probe coagulation, and/or hemoclipping. After then, we will spray 3g of sucralfate powder through colonoscopy precisely on the polypectomy wound in the Sucralfate group, and prophylactic clipping will be placed on the polypectomy wound in the Clipping group. All enrolled patients will be monitored for delayed bleeding for 28 days after the colonoscopy.

Expected results and clinical importance:

This study is expected to find that the use of sucralfate powder can more effectively reduce the bleeding risk in high-risk wounds compared to prophylactic clips. In addition to promoting the implementation of national health policies and reducing public exposure to the risk of complications, it can also help avoid medical expenses resulting from complications.

• Phase: PHASE4

Details

• Lead Sponsor: National Cheng-Kung University Hospital
• Treatments: Sucralfate; Surgical Instruments