Back to resultsCold Snare Polypectomy Versus Hot Snare Polypectomy for Resection of Small Pedunculated Colorectal Polyps：a Randomized Controlled Trial
Primary Purpose
Pedunculated Colorectal Polyps, Haemorrhage
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cold snare polypectomy
hot snare polypectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pedunculated Colorectal Polyps
Eligibility Criteria
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
Sites / Locations
- Ningbo first hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cold snare polypectomy
hot snare polypectomy
Arm Description
cold snare polypectomy for resection of small pedunculated colorectal polyps
hot snare polypectomy for resection of small pedunculated colorectal polyps
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT06097650
First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
Ningbo No. 1 Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06097650
Brief Title
Cold Snare Polypectomy Versus Hot Snare Polypectomy for Resection of Small Pedunculated Colorectal Polyps：a Randomized Controlled Trial
Official Title
Cold Snare Polypectomy Versus Hot Snare Polypectomy for Resection of Small Pedunculated Colorectal Polyps：a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ningbo No. 1 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pedunculated Colorectal Polyps, Haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cold snare polypectomy
Arm Type
Experimental
Arm Description
cold snare polypectomy for resection of small pedunculated colorectal polyps
Arm Title
hot snare polypectomy
Arm Type
Active Comparator
Arm Description
hot snare polypectomy for resection of small pedunculated colorectal polyps
Intervention Type
Other
Intervention Name(s)
cold snare polypectomy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
hot snare polypectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Prevalence of immediate bleeding
Description
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
Time Frame
1 Minutes
Secondary Outcome Measure Information:
Title
delayed hemorrhage
Description
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
Time Frame
2 weeks and 4 weeks
Other Pre-specified Outcome Measures:
Title
Immediate perforation rate
Description
perforation
Time Frame
30 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Xu
Phone
+8613486659126
Email
xulei22@163.com
Facility Information:
Facility Name
Ningbo first hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Xu, MD
Phone
+86-13486659126
Email
xulei22@163.com
12. IPD Sharing Statement
Learn more about this trial
Cold Snare Polypectomy Versus Hot Snare Polypectomy for Resection of Small Pedunculated Colorectal Polyps：a Randomized Controlled Trial
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