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)

NCT06658561 | Not Yet Recruiting DMC

• 1 other identifier: RuijinH20241532
• Study Type: interventional
• Target: 982
• Locations: 1 country
• Sites: 1

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.

Conditions

Cold Snare Resection; Hot Snare Resection; Polyps of Colon

Keywords

cold snare resection; hot snare resection; colorectal Polyps

Outcome Measures

Primary Outcomes (1)

• Complete resection rate

  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.

  Up to 5-7 days from operation day

Secondary Outcomes (6)

• Postoperative delayed bleeding rate

  Up to 14 days from operation day

• Intraoperative bleeding rate

  Up to 1 minute from the time the polyp is resected

• En bloc resection rate

  Up to 7 days when the pathologists finish the evaluations.

• Operation time

  From the snare/ injection needle exits the working channel to leaving the wound.

• Other related postoperative complications

  Up to 48 Hours from the time the polyp is resected

Study Arms (2)

cold snare polypectomy group

OTHER

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.

Procedure: cold snare polypectomy

hot snare polypectomy group

OTHER

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.

Procedure: hot snare polypectomy

Interventions

cold snare polypectomy 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.

Also known as: CSP

cold snare polypectomy group

hot snare polypectomy 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.

Also known as: HSP

hot snare polypectomy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead
• Jinshan Hospital Fudan University: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• The Third People's Hospital Yunnan: collaborator
• People's Hospital Mojiang: collaborator
• Shanghai Yueyang Integrated Medicine Hospital: collaborator
• Huadong Hospital: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Duowu Zou, PHD/MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taojing Ran, MD

CONTACT

8615601942397; rantaojing@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Department

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: October 26, 2024
• Study Start: October 15, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)