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

Wuhan University

Status: Unknown

Conditions: Colorectal Polyp; Post-polypectomy Bleeding

Treatments: Procedure: clip closure; Procedure: argon plasma coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05250518

WDRY2022-K018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,017 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,017 participants in 3 patient groups

the control group

No Intervention group

Description:

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

APC group

Experimental group

Description:

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

Treatment:

Procedure: argon plasma coagulation

Clip group

Experimental group

Description:

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

Treatment:

Procedure: clip closure