Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy

NCT ID: NCT05250518

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1017 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-10-31

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.

Conditions

Post-polypectomy Bleeding; Colorectal Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

the control group

The control group will receive no prophylaxis of post-procedure bleeding.

Group Type: NO_INTERVENTION

No interventions assigned to this group

APC group

The APC group will receive prophylaxis of post-procedure bleeding with argon plasma coagulation.

Group Type: EXPERIMENTAL

argon plasma coagulation

Intervention Type: PROCEDURE

After hot snare polypectomy, participants will be randomized assigned to the APC group for argon plasma coagulation to prevent colorectal post-procedure bleeding.

Clip group

The Clip group will receive prophylaxis of post-procedure bleeding with clip closure.

Group Type: EXPERIMENTAL

clip closure

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. age>18 years

2. the diagnosis of colorectal polyps is clear（Paris Ip or â… sp）

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 â…¢ 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

ChenMingkai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingkai Chen, Ph.D & M.D

Role: STUDY_DIRECTOR

Renmin Hospital of Wuhan University

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Central Contacts

Mingkai Chen, Ph.D & M.D

Role: CONTACT

chenmingkai@whu.edu.cn

+86 13720330580

Other Identifiers

WDRY2022-K018

Identifier Type: -

Identifier Source: org_study_id