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

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.

Study Overview

• Status: Recruiting
• Conditions: Haemorrhage; Pedunculated Colorectal Polyps
• Intervention / Treatment: Other: hot snare polypectomy; Other: cold snare polypectomy

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Xu; Phone Number: +8613486659126; Email: xulei22@163.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Recruiting
      • Ningbo First Hospital
      • Contact: Lei Xu, MD; Phone Number: +86-13486659126; Email: xulei22@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of immediate bleeding	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	1 Minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delayed hemorrhage	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	2 weeks and 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate perforation rate	perforation	30 seconds

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Hemorrhage; Polyps
• Other Study ID Numbers: 2023-140A-YJ01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No