Colonoscopic Sucralfate Spray in Prevention of Delayed Polypectomy Bleeding
NCT ID: NCT05817656
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
160 participants
INTERVENTIONAL
2023-05-15
2024-04-14
Brief Summary
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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.
Detailed Description
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At National Cheng Kung University Hospital, we analyzed about 20000 patients underwent colon polypectomy from 2010/01/01 to 2022/07/31. A total of 71 patients encountered delayed polypectomy bleeding, and 29 patients (41%) were with colon polyp size between 0.5 - 1 cm. Polyps with size ≥ 0.5 cm were all at risk of delayed polypectomy bleeding. How to prevent delayed polypectomy bleeding is an important issue for both endoscopists and patients.
Regarding the method of polypectomy, a systemic review and meta-analysis pointed out that cold snare polypectomy was with a lower delayed bleeding risk than hot snare polypectomy. However, only colon polyps ≤ 1 cm were preferred candidates for cold snare polypectomy. Wound closure with clipping after polypectomy is another method to reduce the risk of delayed polypectomy bleeding. For colon polyps \> 2 cm in diameter, prophylactic clipping after polypectomy reduces the incidence rate of delayed bleeding. For colon polyps \< 2 cm in diameter, prophylactic clipping was not associated with delayed bleeding occurrence. However, delayed polypectomy bleeding still occurs after clipping.
Sucralfate is a complex of aluminum hydroxide and sucrose octasulfate. Sucralfate dissociates in the acid environment to an anionic form, which can bind to the wound base subsequently. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, peptic ulcers, and colon ulcers. Sucralfate can also improve the clinical response to radiation colitis. With the protective effect of the colon mucosa, sucralfate can cover the polypectomy wound and has the potential to avoid further environmental damage from the colon. However, the effect of sucralfate on the prevention of polypectomy bleeding has not been evaluated. This study aimed to investigate whether the precise sucralfate administration on polypectomy wounds can prevent the wound from delayed bleeding.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group
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.
Sucralfate
3g of sucralfate powder through colonoscopy will be sprayed precisely on the polypectomy wound in the intervention group
Control group
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.
No interventions assigned to this group
Interventions
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Sucralfate
3g of sucralfate powder through colonoscopy will be sprayed precisely on the polypectomy wound in the intervention group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients rejection
20 Years
ALL
No
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Principal Investigators
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Xi-Zhang Lin, M.D.
Role: STUDY_DIRECTOR
National Cheng Kung University
Locations
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Hsueh-Chien Chiang
Tainan City, Other (Non U.s.), Taiwan
Countries
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Central Contacts
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Facility Contacts
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Hsueh-Chien Chiang
Role: primary
References
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Other Identifiers
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A-BR-111-085
Identifier Type: -
Identifier Source: org_study_id