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

Colorectal Polyp Clinical Trial

— APC?HSP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05250518
• Other study ID #: WDRY2022-K018
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: October 2023

Study information

• Verified date: February 2022
• Source: Renmin Hospital of Wuhan University
• Contact: Mingkai Chen, Ph.D & M.D
• Phone: +86 13720330580
• Email: chenmingkai[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1017
• Est. completion date: October 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age>18 years

2. the diagnosis of colorectal polyps is clear(Paris Ip or ?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 ? 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

Related Conditions & MeSH terms

• Colorectal Polyp
• Hemorrhage
• Post-polypectomy Bleeding

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of re-bleeding	the rate of re-bleeding within 30 days after operation	30 days after HSP
Secondary	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
Secondary	Other postoperative complications	Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.)	30 days after HSP
Secondary	Expenses of prevention	Expenses of argon plasma coagulation and clips	the 1 day of discharge from medical centers