Clinical trial NCT05250518: Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy
Official title: Comparison of Argon Plasma Coagulation and Clip Closure for the Prophylaxis of Colorectal Post-polypectomy Bleeding After Hot Snare Polypectomy: a Multicenter, Randomized and Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-polypectomy Bleeding
Colorectal Polyp
Keywords: hot snare polypectomy
argon plasma coagulation
clip closure
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 1017
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Discuss the efficacy and safety of argon plasma coagulation （APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）; analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.

Detailed description: This is a multicenter, randomized and controlled study. It aims to discuss the efficacy and safety of argon plasma coagulation（APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）, and analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.

According to the prophylaxis measures, patients enrolled in this study will be randomized into the control group, APC group and Clip group. It will collect participants' data of baseline character, postoperative and follow-up. All statistical analyses will be performed by SPSS 26.0 and Tree Age Pro 2011.

Based on the previous studies, it is presumed that the rate of PPB for the control group, Clip group and APC group is 8%, 2% and 2%. Given two-side testing, an alpha of 0.05 and a power of 90%, allowing for a 5% dropout rate, the smallest sample size is 1287.

Eligibility criteria: Inclusion Criteria:

1. age\>18 years
2. the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp）
3. head diameter≥ 10 mm
4. HSP indications were met and no contraindications were found
5. patients (or the legal representative/guardian) with informed consent

Exclusion Criteria:

1. ASA Grade Ⅲ or above, or end-stage disease of major organs (such as malignancy, heart failure, chronic obstructive pulmonary disease, end-stage renal disease and so on)
2. coagulation dysfunction (INR ≥ 1.5, PLT \< 50×10 \^9 / L)
3. use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation
4. there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient
5. incomplete closure of clips (complete closure: spacing between adjacent clips \< 1cm)
6. APC is used for polypectomy or intraoperative hemostasis, rather than preventing PPB
7. surgical treatment, vascular intervention, or blood products were used during the operation
8. use other methods to prevent PPB
9. the bleeding site was not confirmed by endoscopy
10. history of intestinal surgery
11. menstruation or pregnancy
12. not following medical advice
13. participated in other clinical trials and signed its informed consent

Primary outcomes:
measure: The rate of re-bleeding
timeFrame: 30 days after HSP
Secondary outcomes:
measure: Location of re-bleeding sites
timeFrame: 30 days after HSP
measure: Other postoperative complications
timeFrame: 30 days after HSP
measure: Expenses of prevention
timeFrame: the 1 day of discharge from medical centers
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Mingkai Chen, Ph.D & M.D
role: STUDY_DIRECTOR
References: