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

NCT02717598 | Completed DMC

• 1 other identifier: 2016LL001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cold snare polypectomy; hot snare polypectomy

Outcome Measures

Primary Outcomes (1)

• complete polyp resection rate

  The primary study outcome was to compare the complete polyp resection rate between groups.Complete resection was defined as the absence of residual polyp tissue in the EMR sections of the polypectomy site.

  one year

Secondary Outcomes (1)

• rate of postpolypectomy adverse events

  one year

Study Arms (2)

CSP

EXPERIMENTAL

Cold snare polypectomy is an easy-to-apply technique and has been the most popular technique esprcially for small and diminutive polyps. Briefly, the endoscopist advances the snare sheath, opens the snare and encircles the polyp. The snare is then slowly and progressively closed, with the aim of capturing 1-2 mm of normal tissue around the polyp, until complete closure is achieved and the polyp is guillotined. The polyp can then be suctioned and retrieved for histologic assessment.

Procedure: cold snare polypectomy

HSP

EXPERIMENTAL

Hot snare polypectomy, the endoscopist advances the snare sheath, opens the snare and encircles the polyp. The snare is then slowly and progressively closed, with the aim of capturing 1-2 mm of normal tissue around the polyp,then use Electrocoagulation until complete closure is achieved and the polyp is guillotined. The polyp can then be suctioned and retrieved for histologic assessment.

Procedure: hot snare polypectomy

Interventions

cold snare polypectomy PROCEDURE

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.

Also known as: CSP

CSP

hot snare polypectomy PROCEDURE

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.

Also known as: HSP

HSP

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged ≥20 years who undergo a screening, surveillance, or diagnostic colonoscopy and are subsequently found to have colorectal polyps measuring 3-9 mm in size
• Patients who signed an informed consent

You may not qualify if:

• patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
• known coagulopathy
• history of inflammatory bowel diseases
• polyposis syndrom
• Type IV shantian colorectal polyps
• American Society of Anesthesiology class III or more
• pregnancy
• Unable to provide informed consent.

Sponsors & Collaborators

• Wulumuqi General Hospital of Lanzhou Military Command: lead
• Air Force Military Medical University, China: collaborator

Study Sites (1)

Digestive Disease Center of Wulumuqi General Hospital of Lanzhou Military Command

Ürümqi, Xinjiang, 830000, China

Location

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MeSH Terms

Conditions

Colonic Polyps; Intestinal Polyps

Condition Hierarchy (Ancestors)

Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhan G Nie, professor

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of The Fourth Military Medical University

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 23, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)