Cold Snare Polypectomy Versus Hot Snare Polypectomy for Diminutive and Small Colorectal Polyps

NCT02717598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2017-08-30

No results posted yet for this study

Summary

Background:The optimal technique for removal of diminutive or small colorectal polyps is debatable.

Objective:To compare the complete resection rates of cold snare polypectomy (CSP) and hot snare polypectomy (HSP) for the removal of adenomatous polyps(3-9mm).

Design:Prospective randomized controlled study. Setting:Three tertiary referral hospitals. Patients:we will recruit a total of 330 polyps(3-9mm). Interventions:Enrolled patients were randomly assigned to one of the two polypectomy protocols (CSP vs. HSP) using a computer-generated random sequence. If a patient had one or more polyps, all eligible polyps were removed using the initially assigned polypectomy protocol. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue.

Main Outcome Measurements:The primary study outcome was to compare the complete polyp resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse events, including bleeding, perforations,infection and rate of tissue retrieval(Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site).

Conditions

  • Colonic Polyp
  • Intestinal Polyp

Interventions

PROCEDURE

cold snare polypectomy

CSP was performed by using a disposable oval snare with a diameter of 10 mm under gentle suction to reduce colon wall tension. The tip of the endoscope was deflected toward the polyp base to ensnare 1 to 2 mm of normal mucosa surrounding the polyp. Afterward, additional EMR was performed at the polypectomy site to evaluate for the presence of residual polyp tissue,including an additional 1 to 2 mm clear margin, was resected by the snare and Endocut current after submucosal injection of a mixed solution.In the event that no tissue could be removed or if EMR failed to get in situ mucosal specimens. At least four cold biopsies using forceps on the remaining margins were obtained.After each procedure, the polypectomy site was observed for 30 seconds to confirm the absence of immediate bleeding.Cross-sections of the EMR specimens were collected at 1-mm intervals.

PROCEDURE

hot snare polypectomy

HSP, which is using electrocoagulation on the basis of using cold snare.After HSP, another independent endoscopic surgeon judged whether the endoscopic eradication was successful. Afterward, additional EMR was performed at the polypectomy site to evaluate for the presence of residual polyp tissue,including an additional 1 to 2 mm clear margin, was resected by the snare and Endocut current after submucosal injection of a mixed solution.In the event that no tissue could be removed or if EMR failed to get in situ mucosal specimens. At least four cold biopsies using forceps on the remaining margins were obtained.After each procedure, the polypectomy site was observed for 30 seconds to confirm the absence of immediate bleeding, the specimens were retrieved and stored in formalin. Cross-sections of the EMR specimens were collected at 1-mm intervals; accurate tissue section of the marked site was ensured.

Sponsors & Collaborators

  • Air Force Military Medical University, China

    collaborator OTHER
  • Wulumuqi General Hospital of Lanzhou Military Command

    lead OTHER

Principal Investigators

  • Zhan G Nie, professor · Air Force Military Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-04-30
Completion
2017-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02717598 on ClinicalTrials.gov