Clinical trial NCT05817656: Colonoscopic Sucralfate Spray in Prevention of Delayed Polypectomy Bleeding
Official title: Precise Administration of Sucralfate Powder in Prevention of Delayed Polypectomy Bleeding: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bleeding
Keywords: Polypectomy bleeding
Sulcralfate
Colonoscopic spray
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Colonoscopy is the gold standard for the detection of colon polyps for cancer prevention. Colonoscopic polypectomy with the snare is an effective and safe procedure. However, polypectomy bleeding has about a 0.4 % event rate. Polypectomy bleeding can be divided into two types- immediate or delayed polypectomy bleeding. Immediate polypectomy bleeding occurs right after the polyp excision, which can be detected right away with endoscopic hemostasis treatment. Old age ≥ 65 years, comorbid cardiovascular or chronic kidney disease, antiplatelet or anticoagulant agents use, polyp size \> 1 cm, laterally spreading polyp, and thick polyp stalk was related to an increased risk of immediate polypectomy bleeding. In contrast, delayed polypectomy bleeding occurs hours or days after the polypectomy. Polyp size \> 1 cm, antiplatelet or anticoagulant agents use, the occurrence of immediate polypectomy bleeding, and polyps at the right colon are known risk factors for delayed polypectomy bleeding. An increased size of polyp for every 1 mm significantly increased bleeding by 13%5. Patients who encountered delayed polypectomy bleeding usually presented to the hospital for hematochezia, symptoms of anemia, and even hemodynamic instability and end-organ damage. A polypectomy bleeding-related mortality related was reported at about 0.08%.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients with an allergy to sucralfate
* patients rejection

Primary outcomes:
measure: Incidence rate of delayed polypectomy bleeding
timeFrame: 28 days
Secondary outcomes:
measure: Incidence rate of need of TAE or surgery
timeFrame: 28 days
measure: length of hospitalization
timeFrame: 28 days
measure: all-cause mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Hsueh-Chien Chiang
state: Other (Non U.s.)
Study officials:
affiliation: National Cheng Kung University
name: Xi-Zhang Lin, M.D.
role: STUDY_DIRECTOR
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