NCT05250518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,017

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

February 18, 2022

Last Update Submit

February 21, 2022

Conditions

Post-polypectomy BleedingColorectal Polyp

Keywords

hot snare polypectomyargon plasma coagulationclip closure

Outcome Measures

Primary Outcomes (1)

  • The rate of re-bleeding

    the rate of re-bleeding within 30 days after operation

    30 days after HSP

Secondary Outcomes (3)

  • Location of re-bleeding sites

    30 days after HSP

  • Other postoperative complications

    30 days after HSP

  • Expenses of prevention

    the 1 day of discharge from medical centers

Study Arms (3)

the control group

NO INTERVENTION

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

APC group

EXPERIMENTAL

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

Procedure: argon plasma coagulation

Clip group

EXPERIMENTAL

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

Procedure: clip closure

Interventions

argon plasma coagulationPROCEDURE

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

APC group
clip closurePROCEDURE

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.

Clip group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

MeSH Terms

Interventions

Argon Plasma CoagulationSurgical Instruments

Intervention Hierarchy (Ancestors)

ElectrocoagulationCauteryTherapeuticsHemostatic TechniquesAblation TechniquesSurgical Procedures, OperativeHemostasis, SurgicalSurgical EquipmentEquipment and Supplies

Study Officials

  • Mingkai Chen, Ph.D & M.D

    Renmin Hospital of Wuhan University

    STUDY DIRECTOR

Central Study Contacts

Mingkai Chen, Ph.D & M.D

CONTACT

+86 13720330580chenmingkai@whu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 18, 2022

First Posted

February 22, 2022

Study Start

March 1, 2022

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

February 22, 2022

Record last verified: 2022-02

Locations

CN(1)