Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy (APC、HSP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Polyp; Post-polypectomy Bleeding
• Intervention / Treatment: Procedure: argon plasma coagulation; Procedure: clip closure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1017
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingkai Chen, Ph.D & M.D; Phone Number: +86 13720330580; Email: chenmingkai@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: the control group; The control group will receive no prophylaxis of post-procedure bleeding.
Experimental: APC group; The APC group will receive prophylaxis of post-procedure bleeding with argon plasma coagulation.	Procedure: argon plasma coagulation; After hot snare polypectomy, participants will be randomized assigned to the APC group for argon plasma coagulation to prevent colorectal post-procedure bleeding.
Experimental: Clip group; The Clip group will receive prophylaxis of post-procedure bleeding with clip closure.	Procedure: clip closure; After hot snare polypectomy, participants will be randomized assigned to the Clip group for complete closure(spacing between adjacent clips < 1cm) to prevent colorectal post-procedure bleeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of re-bleeding	the rate of re-bleeding within 30 days after operation	30 days after HSP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location of re-bleeding sites	the original polyps' location of re-bleeding sites: cecum, ascending colon, colonic hepatic flexure, transverse colon, colonic splenic flexure , descending colon, sigmoid colon, rectum	30 days after HSP
Other postoperative complications	Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.)	30 days after HSP
Expenses of prevention	Expenses of argon plasma coagulation and clips	the 1 day of discharge from medical centers

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: argon plasma coagulation; hot snare polypectomy; clip closure
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: WDRY2022-K018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No