Efficacy and Safety Research of Cold Snare Polypectomy and Hot Snare Polypectomy in the Treatment of 4-9 mm Diameter Colorectal 0-Isp and 0-Ip Polyps: a Prospective, Multicenter, Randomized Controlled Study(FAST -REST Study)

Not Applicable

Not yet recruiting

• Conditions: Cold Snare Resection; Hot Snare Resection; Polyps of Colon

• Registration Number: NCT06658561
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. The conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-Isp and 0-Ip polyps, and provide more effective treatment for patients.

Detailed Description

Colorectal polyps are one of the precancerous lesions of colorectal cancer, 60-80% of which eventually become advanced colorectal cancer. Therefore, early resection of colorectal polyps can effectively reduce the incidence of colorectal cancer. Polyps under white light are judged mainly according to the shape, size and color of polyps. At present, the Paris classification is often used to divide 0-I uplifted polyps into sessile polyps (0-Is), sessile-pedunculated polyps (0-Isp) and pedunculated polyps (0-Ip). It is generally believed that there are thick arteries in 0-Ip polyps, especially thick pedunculated polyps, which are prone to uncontrollable bleeding during operation. 0-Is polyps have small scattered blood vessels and low intraoperative bleeding risk, while the morphological and structural characteristics of 0-Isp polyps are between the two. The current guidelines recommend HSP for 0-Isp and 0-Ip polyps \<1 cm, but the internal blood vessels of these polyps are not thick. There is no guidance on whether they can be resected by CSP method, and there is a lack of prospective large sample clinical research. This study will include0-Isp /0-Ip polyps \<1cm, and observe the safety and effectiveness of CSP for the above polyp resection , so as to provide reference for the clinical treatment of colorectal polyps.

Study Timeline

• Study First Submitted: 2024-07-18
• Status Verified: 2024-10
• Study Start: 2024-10-15
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-02-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 982

Inclusion Criteria

1. Age: 18-80 years old, male or female
2. At least one polyp with size of 4-9 mm 0-Isp or 0-Ip is found during colonoscopy
3. Voluntarily sign informed consent for endoscopic treatment

Exclusion Criteria

1. Boston Bowel Preparation Scale<6 points.
2. Patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy.
3. Participants with a contraindication to colonoscopy and polypectomy.
4. Patients with inflammatory bowel disease or gastrointestinal polyposis.
5. Lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation.
6. Patients with pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete resection rate	Up to 5-7 days from operation day	The polyps and the two biopsies from the margin will be sent to the pathologist for further analysis. Two independent experienced pathologists will evaluate the samples separately and both are blinded to the technique performed for polypectomy. Complete resection rate is defined as the negative pathological evaluation of two biopsies obtained from the margin.

Secondary Outcome Measures

Name	Time	Method
Postoperative delayed bleeding rate	Up to 14 days from operation day	Incidence of bleeding requiring endoscopic hemostasis intervention within 14 days after surgery
Intraoperative bleeding rate	Up to 1 minute from the time the polyp is resected	Immediate bleeding is defined as bleeding persists \>60s after polypectomy according to the ESGE recommendations (2017) and requires for endoscopic intervention.
En bloc resection rate	Up to 7 days when the pathologists finish the evaluations.	The lesion is removed at one time, and the integrity of the specimen is maintained
Operation time	From the snare/ injection needle exits the working channel to leaving the wound.	CSP: the time from the time the snare exits the working channel to leaving the wound. Hsp: time from the injection needle leaving the working channel to leaving the wound
Other related postoperative complications	Up to 48 Hours from the time the polyp is resected	Perforation, infection, electrocoagulation syndrome, etc
Number of metal clips used	The time when the operation is completed	Whether metal clips are used for hemostasis, and the number of metal clips

Trial Locations

Locations (1)

Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China