Colonoscopic Sucralfate Spray in Prevention of Delayed Polypectomy Bleeding

NCT05817656 | Unknown Phase 1

• 1 other identifier: A-BR-111-085
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Background： Colonoscopy can detect colon polyps and perform excision to the polyps to prevent colon cancer. However, polypectomy bleeding is one of the complications to be noticed, which has an occurrence rate of about 0.4%. Polypectomy bleeding is divided into two types, immediate and delayed bleeding. While immediate polypectomy bleeding can be treated with endoscopic hemostasis during the exam session, delayed polypectomy bleeding occurs a few hours or days after the colonoscopy exam. Patients who encountered delayed polypectomy bleeding usually presented to the hospital for hematochezia, symptoms of anemia, and even hemodynamic instability and end-organ damage. Cold snare polypectomy and prophylactic clipping can reduce the bleeding risk. However, delayed polypectomy bleeding still occurs in high-risk patients, e.g., larger polyps ≥ 1cm. Sucralfate is used for peptic ulcer treatment. It can become a protective layer on the wound to prevent environmental injury. Sucralfate can be used to treat colon ulcers, colitis, and radiation colitis. Whether sucralfate can prevent polypectomy wounds from delayed bleeding is unknown. Aim： This study aimed to investigate whether precise sucralfate administration on polypectomy wounds can prevent the wound from delayed bleeding. Method： This is a randomized clinical trial. The study will recruit 160 patients. After randomization, 80 patients will be classified into the intervention group and 80 into the control group. The participants will receive an endoscopic survey as routine, and we will enroll all patients with polyp size ≥ 0.5 cm after 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. If there is no immediate bleeding, we will apply prophylactic clipping in high-risk patients with polyp size ≥ 1cm. After then, we will spray 3g of sucralfate powder through colonoscopy precisely on the polypectomy wound in the intervention group. All enrolled patients will be monitored for delayed bleeding for 28 days after the colonoscopy.

Conditions

Bleeding

Keywords

Polypectomy bleeding; Sulcralfate; Colonoscopic spray

Outcome Measures

Primary Outcomes (1)

• Incidence rate of delayed polypectomy bleeding

  The occurrence of delayed polypectomy bleeding. Delayed polypectomy was classified into standard criteria and extended criteria. Standard criteria of delayed postpolypectomy bleeding was defined as emergency attendance, hospitalisation, or need for re-intervention. Extended criteria was defined as blood in stool two days after procedure with or without spontaneous remission.

  28 days

Secondary Outcomes (3)

• Incidence rate of need of TAE or surgery

  28 days

• length of hospitalization

  28 days

• all-cause mortality

  28 days

Study Arms (2)

Intervention group

EXPERIMENTAL

After polypectomy with a suitable method, either cold snare polypectomy, hot snare polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection, we will monitor if immediate polypectomy bleeding occurs. If immediate bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine, heater probe coagulation, and/or hemoclipping. If there is no immediate bleeding, we will apply prophylactic clipping in high-risk patients with polyp size ≥ 1cm. After then, we will spray 3g of sucralfate powder through colonoscopy precisely on the polypectomy wound in the intervention group.

Drug: Sucralfate

Control group

NO INTERVENTION

After polypectomy with a suitable method, either cold snare polypectomy, hot snare polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection, we will monitor if immediate polypectomy bleeding occurs. If immediate bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine, heater probe coagulation, and/or hemoclipping. If there is no immediate bleeding, we will apply prophylactic clipping in high-risk patients with polyp size ≥ 1cm.

Interventions

Sucralfate DRUG

3g of sucralfate powder through colonoscopy will be sprayed precisely on the polypectomy wound in the intervention group

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who accept colonoscopy examinations with polyp size ≥ 0.5 cm for polyp excision

You may not qualify if:

• patients with an allergy to sucralfate
• patients rejection

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Hsueh-Chien Chiang

Tainan, Other (Non U.s.), 704, Taiwan

RECRUITING

Related Publications (21)

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  PMID: 39836033 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Sucralfate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Xi-Zhang Lin, M.D.

  National Cheng Kung University

  STUDY DIRECTOR

Central Study Contacts

Hsueh-Chien Chiang, M.D.

CONTACT

+886 2353535; scion456scion@gmail.com

Ming-Tsung Hsieh, M.D.

CONTACT

+886 2353535; csgigo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: May 15, 2023
• Primary Completion: April 14, 2024
• Study Completion: April 14, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 10 years

Locations

TW (1)