Back to resultsArgon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy (APC、HSP)
Primary Purpose
Post-polypectomy Bleeding, Colorectal Polyp
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
argon plasma coagulation
clip closure
Sponsored by
About this trial
This is an interventional prevention trial for Post-polypectomy Bleeding focused on measuring hot snare polypectomy, argon plasma coagulation, clip closure
Eligibility Criteria
Inclusion Criteria:
- age>18 years
- the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp）
- head diameter≥ 10 mm
- HSP indications were met and no contraindications were found
- patients (or the legal representative/guardian) with informed consent
Exclusion Criteria:
- 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)
- coagulation dysfunction (INR ≥ 1.5, PLT < 50×10 ^9 / L)
- use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation
- there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient
- incomplete closure of clips (complete closure: spacing between adjacent clips < 1cm)
- APC is used for polypectomy or intraoperative hemostasis, rather than preventing PPB
- surgical treatment, vascular intervention, or blood products were used during the operation
- use other methods to prevent PPB
- the bleeding site was not confirmed by endoscopy
- history of intestinal surgery
- menstruation or pregnancy
- not following medical advice
- participated in other clinical trials and signed its informed consent
Sites / Locations
- Renmin Hospital of Wuhan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
the control group
APC group
Clip group
Arm Description
The control group will receive no prophylaxis of post-procedure bleeding.
The APC group will receive prophylaxis of post-procedure bleeding with argon plasma coagulation.
The Clip group will receive prophylaxis of post-procedure bleeding with clip closure.
Outcomes
Primary Outcome Measures
The rate of re-bleeding
the rate of re-bleeding within 30 days after operation
Secondary Outcome Measures
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
Other postoperative complications
Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.)
Expenses of prevention
Expenses of argon plasma coagulation and clips
Full Information
NCT ID
NCT05250518
First Posted
February 18, 2022
Last Updated
February 21, 2022
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT05250518
Brief Title
Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Renmin Hospital of Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-polypectomy Bleeding, Colorectal Polyp
Keywords
hot snare polypectomy, argon plasma coagulation, clip closure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1017 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the control group
Arm Type
No Intervention
Arm Description
The control group will receive no prophylaxis of post-procedure bleeding.
Arm Title
APC group
Arm Type
Experimental
Arm Description
The APC group will receive prophylaxis of post-procedure bleeding with argon plasma coagulation.
Arm Title
Clip group
Arm Type
Experimental
Arm Description
The Clip group will receive prophylaxis of post-procedure bleeding with clip closure.
Intervention Type
Procedure
Intervention Name(s)
argon plasma coagulation
Intervention Description
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
Intervention Name(s)
clip closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of re-bleeding
Description
the rate of re-bleeding within 30 days after operation
Time Frame
30 days after HSP
Secondary Outcome Measure Information:
Title
Location of re-bleeding sites
Description
the original polyps' location of re-bleeding sites: cecum, ascending colon, colonic hepatic flexure, transverse colon, colonic splenic flexure , descending colon, sigmoid colon, rectum
Time Frame
30 days after HSP
Title
Other postoperative complications
Description
Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.)
Time Frame
30 days after HSP
Title
Expenses of prevention
Description
Expenses of argon plasma coagulation and clips
Time Frame
the 1 day of discharge from medical centers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age>18 years
the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp）
head diameter≥ 10 mm
HSP indications were met and no contraindications were found
patients (or the legal representative/guardian) with informed consent
Exclusion Criteria:
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)
coagulation dysfunction (INR ≥ 1.5, PLT < 50×10 ^9 / L)
use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation
there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient
incomplete closure of clips (complete closure: spacing between adjacent clips < 1cm)
APC is used for polypectomy or intraoperative hemostasis, rather than preventing PPB
surgical treatment, vascular intervention, or blood products were used during the operation
use other methods to prevent PPB
the bleeding site was not confirmed by endoscopy
history of intestinal surgery
menstruation or pregnancy
not following medical advice
participated in other clinical trials and signed its informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingkai Chen, Ph.D & M.D
Phone
+86 13720330580
Email
chenmingkai@whu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingkai Chen, Ph.D & M.D
Organizational Affiliation
Renmin Hospital of Wuhan University
Official's Role
Study Director
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided
Learn more about this trial
Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy
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