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Not yet recruiting 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)

No phase Interventional Cold Snare Resection Hot Snare Resection Polyps of Colon

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cold snare polypectomy, hot snare polypectomy.
Who it may be relevant to
Registry conditions: Cold Snare Resection, Hot Snare Resection, Polyps of Colon. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Complete resection rate [Time frame: Up to 5-7 days from operation day]
Secondary outcome measures (6)
  • Postoperative delayed bleeding rate [Time frame: Up to 14 days from operation day]
  • Intraoperative bleeding rate [Time frame: Up to 1 minute from the time the polyp is resected]
  • En bloc resection rate [Time frame: Up to 7 days when the pathologists finish the evaluations.]
  • Operation time [Time frame: From the snare/ injection needle exits the working channel to leaving the wound.]
  • Other related postoperative complications [Time frame: Up to 48 Hours from the time the polyp is resected]
  • Number of metal clips used [Time frame: The time when the operation is completed]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University — Shanghai

Identifiers

NCT: NCT06658561 · RuijinH20241532

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗