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)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • cold snare polypectomy

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

982 Participants
are divided into 2 treatment groups
Group A: cold snare polypectomy groupOther 1 intervention
Group B: hot snare polypectomy groupOther 1 intervention

Trial outcomes

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.

Time frame
Up to 5-7 days from operation day

Secondary outcomes

1

Postoperative delayed bleeding rate

Incidence of bleeding requiring endoscopic hemostasis intervention within 14 days after surgery

Time frame
Up to 14 days from operation day
2

Intraoperative bleeding rate

Immediate bleeding is defined as bleeding persists \>60s after polypectomy according to the ESGE recommendations (2017) and requires for endoscopic intervention.

Time frame
Up to 1 minute from the time the polyp is resected
3

En bloc resection rate

The lesion is removed at one time, and the integrity of the specimen is maintained

Time frame
Up to 7 days when the pathologists finish the evaluations.
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Jinshan Hospital Fudan University

Collaborator

Second Affiliated Hospital of Soochow University

Collaborator

The Third People's Hospital of Yunnan Province

Collaborator

People's Hospital Mojiang

Collaborator

Shanghai Yueyang Integrated Medicine Hospital

Collaborator

Huadong Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: