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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polyps of Colon; Cold Snare Resection; Hot Snare Resection
• Intervention / Treatment: Procedure: cold snare polypectomy; Procedure: hot snare polypectomy

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 Type: Interventional
• Enrollment (Estimated): 982
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taojing Ran, MD; Phone Number: 8615601942397; Email: rantaojing@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Taojing Ran, MD; Phone Number: 8615601942397; Email: rantaojing@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cold snare polypectomy group; Rotate the lens body to make the polyp at about 6 o'clock.; 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.; Excision.; According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination.; Piecemeal resection will be performed if the en-bloc resection fails.	Procedure: 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.; Other Names: CSP
Other: hot snare polypectomy group; Rotate the lens body to make the polyp at about 6 o'clock.; 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.; According to the polyp size, use the colonoscope suction channel or directly use the snare to pull out the tissue for further pathological examination.; Piecemeal resection will be performed if the en-bloc resection fails.	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.; Other Names: HSP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Second Affiliated Hospital of Soochow University; Shanghai Yueyang Integrated Medicine Hospital; Jinshan Hospital Fudan University; Huadong Hospital; The Third People's Hospital Yunnan; People's Hospital Mojiang
• Investigators: Principal Investigator: Duowu Zou, PHD/MD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: cold snare resection; hot snare resection; colorectal Polyps
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: RuijinH20241532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No