Cold Snare Polypectomy Versus Hot Snare Polypectomy for Resection of Small Pedunculated Colorectal Polyps:a Randomized Controlled Trial

Sponsor
Ningbo No. 1 Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06097650
Collaborator
(none)
400
1
2
34.4
11.6

Study Details

Study Description

Brief Summary

Endoscopic resection of pedicled polyps mainly focuses on how to prevent bleeding, and also needs to pay attention to the convenience of resection and the integrity of resection, which means that different endoscopic resection strategies should be adopted for pedicled polyps with different pedicle sizes. Small pedicled polyps with heads smaller than 20mm and pedicles smaller than 5mm are defined as having a relatively small risk of bleeding. Preliminary studies in recent years suggest that the use of cold snare polypectomy for small pedicled polyps may also be a safe resection strategy. However, for small pedicled polyps, ASGE and ESGE guidelines currently recommend hot snare polypectomy in the middle and lower pedicles (evidence level medium). Therefore, the provision of high-quality clinical evidence related to cold resection techniques in the resection strategy of small pedicled polyps may provide a basis for revision of guidelines.

Condition or Disease Intervention/Treatment Phase
  • Other: cold snare polypectomy
  • Other: hot snare polypectomy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cold Snare Polypectomy Versus Hot Snare Polypectomy for Resection of Small Pedunculated Colorectal Polyps:a Randomized Controlled Trial
Actual Study Start Date :
Oct 18, 2023
Anticipated Primary Completion Date :
Aug 31, 2026
Anticipated Study Completion Date :
Aug 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: cold snare polypectomy

cold snare polypectomy for resection of small pedunculated colorectal polyps

Other: cold snare polypectomy
Histological analyses suggest that cold snare polypectomy causes less damage to blood vessels in the submucosal layers, which results in a reduced incidence of hemorrhage

Active Comparator: hot snare polypectomy

hot snare polypectomy for resection of small pedunculated colorectal polyps

Other: hot snare polypectomy
Current guidelines recommend preoperative hot snare polypectomy after preoperative saline injection, nylon ring, or metal clip ligation of the tip and pedicle of the polyps

Outcome Measures

Primary Outcome Measures

  1. Prevalence of immediate bleeding [1 Minutes]

    Immediate bleeding was defined as an intraoperative bleeding immediately after polypectomy. Level 2, Level 1 was defined as continuous exudation for 1 minute, and level 2 was defined as active blood spray

Secondary Outcome Measures

  1. delayed hemorrhage [2 weeks and 4 weeks]

    Any symptoms of gastrointestinal bleeding (e. g. hematochezia) occurred within 30 days after polypectomy and were classified as mild or severe according on the severity of the bleeding

Other Outcome Measures

  1. Immediate perforation rate [30 seconds]

    perforation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Patients undergoing endoscopic resection of small and medium pedicled polyps in the First Affiliated Hospital of Ningbo University from October 2023 to August 2026; 2. Age 18-75 years old; 3. Patients who voluntarily agreed to participate in this study and signed informed consent.
Exclusion Criteria:
    1. Persons under 18 years of age 2. Persons unwilling or unable to provide informed consent 3. Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months 4.Malignant polyps have infiltrated the pedicle 5. Abdominal symptoms such as severe abdominal pain, abdominal distension, and nausea 6.Patients with inadequate intestinal preparation 7. Patients with lifelong anticoagulant therapy or severe bleeding diseases, patients who have recently taken anticoagulant drugs or antiplatelet drugs (within 1 week) 8.Pregnant or lactating

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ningbo first hospital Ningbo Zhejiang China 315000

Sponsors and Collaborators

  • Ningbo No. 1 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ningbo No. 1 Hospital
ClinicalTrials.gov Identifier:
NCT06097650
Other Study ID Numbers:
  • 2023-140A-YJ01
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023