Clinical trial NCT06658561: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cold Snare Resection
Hot Snare Resection
Polyps of Colon
Keywords: cold snare resection
hot snare resection
colorectal Polyps
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Jinshan Hospital Fudan University
name: Second Affiliated Hospital of Soochow University
name: The Third People's Hospital Yunnan
name: People's Hospital Mojiang
name: Shanghai Yueyang Integrated Medicine Hospital
name: Huadong Hospital
First posted: 2024-10-26
Enrollment: 982
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&lt;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 \&lt;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.

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.

Primary outcomes:
measure: Complete resection rate
timeFrame: Up to 5-7 days from operation day
Secondary outcomes:
measure: Postoperative delayed bleeding rate
timeFrame: Up to 14 days from operation day
measure: Intraoperative bleeding rate
timeFrame: Up to 1 minute from the time the polyp is resected
measure: En bloc resection rate
timeFrame: Up to 7 days when the pathologists finish the evaluations.
measure: Operation time
timeFrame: From the snare/ injection needle exits the working channel to leaving the wound.
measure: Other related postoperative complications
timeFrame: Up to 48 Hours from the time the polyp is resected
measure: Number of metal clips used
timeFrame: The time when the operation is completed
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Duowu Zou, PHD/MD
role: PRINCIPAL_INVESTIGATOR
References: