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

NCT07257926 | Not Yet Recruiting Phase 4

• 1 other identifier: A-BR-114-027
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

polypectomy; sucralfate; antiplatelet; anticoagulant; postpolypectomy bleeding

Outcome Measures

Primary Outcomes (1)

• Rate of delayed postpolypectomy bleeding

  Delayed postpolypectomy bleeding was defined as the need for reintervention or hospitalization, indicating a clinically significant bleeding event

  28 days

Secondary Outcomes (2)

• Rate of overt bloody stool

  2 days

• Rate of severe bleeding from polypectomy wounds

  28 days

Study Arms (2)

Clipping group

ACTIVE COMPARATOR

After identifying a resectable colon polyp (size ≥ 1 cm), the operator performed a hot polypectomy. Following hot polypectomy, the wound was observed for 30 seconds to detect potential immediate bleeding. Standard endoscopic interventions such as diluted epinephrine injection, heat coagulation, or clipping were promptly administered if immediate bleeding occurred. Subsequently, the patients were randomly assigned to either the Sucralfate or Clipping groups. After allocation, prophylactic clips will be placed on the polypectomy wounds of patients in the Clipping group.

Device: Clip

Sucralfate group

EXPERIMENTAL

After identifying a resectable colon polyp (size ≥ 1 cm), the operator performed a hot polypectomy. Following hot polypectomy, the wound was observed for 30 seconds to detect potential immediate bleeding. Standard endoscopic interventions such as diluted epinephrine injection, heat coagulation, or clipping were promptly administered if immediate bleeding occurred. Subsequently, the patients were randomly assigned to either the Sucralfate or Clipping groups. After allocation, 3 g of sucralfate powder will be sprayed on the polypectomy wounds of patients in the Sucralfate group. The powder spray aimed for the full coverage of the polypectomy wound. Six sucralfate tablets (500 mg per Weizip tablet; Yung Shin Pharmaceutical Industries, Taichung, Taiwan) were ground to collect 3 g of sucralfate powder. This powder was then delivered through a functional powder delivery system (7F polyethylene catheter in connection by an oxygen cannula to the air source; propelling power: 1 L/min airflow)

Drug: Sucralfate

Interventions

Sucralfate DRUG

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

Sucralfate group

Clip DEVICE

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

Clipping group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who take antiplatelets or anticoagulants with large polyps (size ≥ 1 cm)

You may not qualify if:

• lacked complete data (serum creatinine, platelet count, and prothrombin time) pertaining to the previous 6 months
• those who did not discontinue or inadequately discontinued antiplatelet agents or anticoagulants
• those who had a known allergy to sucralfate

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Related Publications (13)

• Chiang HC, Chen PJ, Yang EH, Kuo TL, Hsieh MT, Kang JW, Cheng HC, Chang WL, Chen WY, Chiu HC, Lin MY, Hong TC, Chiang CM, Chen WC, Huang KK, Lu MH, Wu MH, Chen CY, Lin XZ, Chuang CH. Clinical Trial: Precise Administration of Sucralfate Powder in Prevention of Delayed Postpolypectomy Bleeding. A Randomized Controlled Trial. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00818. doi: 10.14309/ctg.0000000000000818.

  PMID: 39836033 RESULT

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  PMID: 31907166 RESULT

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  PMID: 31525836 RESULT

• Buddingh KT, Herngreen T, Haringsma J, van der Zwet WC, Vleggaar FP, Breumelhof R, Ter Borg F. Location in the right hemi-colon is an independent risk factor for delayed post-polypectomy hemorrhage: a multi-center case-control study. Am J Gastroenterol. 2011 Jun;106(6):1119-24. doi: 10.1038/ajg.2010.507. Epub 2011 Jan 25.

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  PMID: 34992406 RESULT

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  PMID: 18938166 RESULT

• Kim HS, Kim TI, Kim WH, Kim YH, Kim HJ, Yang SK, Myung SJ, Byeon JS, Lee MS, Chung IK, Jung SA, Jeen YT, Choi JH, Choi KY, Choi H, Han DS, Song JS. Risk factors for immediate postpolypectomy bleeding of the colon: a multicenter study. Am J Gastroenterol. 2006 Jun;101(6):1333-41. doi: 10.1111/j.1572-0241.2006.00638.x.

  PMID: 16771958 RESULT

• Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.

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• Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.

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MeSH Terms

Interventions

Sucralfate; Surgical Instruments

Intervention Hierarchy (Ancestors)

Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Hsueh-Chien Chiang, MD

CONTACT

+88662353535; scion456scion@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: After allocation, prophylactic clips will be placed on the polypectomy wounds of patients in the Clipping group. In contrast, 3 g of sucralfate powder will be sprayed on the polypectomy wounds of patients in the Sucralfate group. The powder spray aimed for the full coverage of the polypectomy wound. Six sucralfate tablets (500 mg per Weizip tablet; Yung Shin Pharmaceutical Industries, Taichung, Taiwan) were ground to collect 3 g of sucralfate powder. This powder was then delivered through a functional powder delivery system (7F polyethylene catheter in connection by an oxygen cannula to the air source; propelling power: 1 L/min airflow from the hospital's air source, oxygen or CO2)

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: December 2, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after study publication