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

Haemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097650
• Other study ID #: 2023-140A-YJ01
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Ningbo No. 1 Hospital
• Contact: Lei Xu
• Phone: +8613486659126
• Email: xulei22[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemorrhage
• Hemorrhage
• Polyps

Intervention

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
• 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

Locations

Country	Name	City	State
China	Ningbo first hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immediate perforation rate	perforation	30 seconds
Primary	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	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