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)

NCT ID: NCT06658561

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 982 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2026-03-01

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.

Conditions

Cold Snare Resection; Hot Snare Resection; Polyps of Colon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cold snare polypectomy group

1. Rotate the lens body to make the polyp at about 6 o'clock.

2. Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge.

3. Tighten the snare at a constant speed and gently lift it up.

4. Excision.

5. According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination.

6. Piecemeal resection will be performed if the en-bloc resection fails.

Group Type: OTHER

cold snare polypectomy

Intervention Type: PROCEDURE

Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. Tighten the snare at a constant speed and gently lift it up and then excision.

hot snare polypectomy group

1. Rotate the lens body to make the polyp at about 6 o'clock.

2. According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection.

3. Tighten the snare at a constant speed and gently lift it up.

4. Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.

5. According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination.

6. Piecemeal resection will be performed if the en-bloc resection fails.

Group Type: OTHER

hot snare polypectomy

Intervention Type: PROCEDURE

According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. Tighten the snare at a constant speed and gently lift it up.Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.

Interventions

cold snare polypectomy

Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. Tighten the snare at a constant speed and gently lift it up and then excision.

Intervention Type: PROCEDURE

hot snare polypectomy

According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. Tighten the snare at a constant speed and gently lift it up.Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.

Intervention Type: PROCEDURE

Other Intervention Names

CSP; HSP

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinshan Hospital Fudan University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

The Third People's Hospital Yunnan

UNKNOWN

Sponsor Role: collaborator

People's Hospital Mojiang

UNKNOWN

Sponsor Role: collaborator

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: collaborator

Huadong Hospital

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

ZOU DUOWU

Director of Gastroenterology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duowu Zou, PHD/MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Taojing Ran, MD

Role: CONTACT

rantaojing@163.com

8615601942397

Facility Contacts

Taojing Ran, MD

Role: primary

rantaojing@163.com

8615601942397

Other Identifiers

RuijinH20241532

Identifier Type: -

Identifier Source: org_study_id