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

NCT07257926 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Bleeding After GI Endoscopy

Interventions

DRUG

Sucralfate

3 g of sucralfate powder will be sprayed on the polypectomy wounds of patients in the Sucralfate group.

DEVICE

Clip

Prophylactic clips will be placed on the polypectomy wounds of patients in the Clipping group

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257926 on ClinicalTrials.gov