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Cold Snare Polypectomy Versus Hot Snare Polypectomy for Diminutive and Small Colorectal Polyps (CSPVsHSP)

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ClinicalTrials.gov Identifier: NCT02717598
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by (Responsible Party):
Zhanguo Nie,Professor, Wulumuqi General Hospital of Lanzhou Military Command

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).


Condition or disease Intervention/treatment Phase
Colonic Polyp Intestinal Polyp Procedure: cold snare polypectomy Procedure: hot snare polypectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cold Snare Polypectomy Versus Hot Snare Polypectomy for Diminutive and Small Colorectal Polyps: a Randomized Controlled Trial
Actual Study Start Date : February 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: CSP
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
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.
Other Name: CSP

Experimental: HSP
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
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.
Other Name: HSP




Primary Outcome Measures :
  1. complete polyp resection rate [ Time Frame: one year ]
    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.


Secondary Outcome Measures :
  1. rate of postpolypectomy adverse events [ Time Frame: one year ]
    Secondary outcomes included rate of postpolypectomy adverse events, including bleeding, perforations,infection and rate of tissue retrieval



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717598


Locations
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China, Xinjiang
Digestive Disease Center of Wulumuqi General Hospital of Lanzhou Military Command
Wulumuqi, Xinjiang, China, 830000
Sponsors and Collaborators
Wulumuqi General Hospital of Lanzhou Military Command
Fourth Military Medical University
Investigators
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Principal Investigator: Zhan G Nie, professor Fourth Military Medical University
Publications of Results:
Other Publications:
373 Cold snare versus hot snare polypectomy for the complete resection of 5-9 mm sized colorectal polyps A randomized controlled trial.

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Responsible Party: Zhanguo Nie,Professor, Professor of The Fourth Military Medical University, Wulumuqi General Hospital of Lanzhou Military Command
ClinicalTrials.gov Identifier: NCT02717598    
Other Study ID Numbers: 2016LL001
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: there is a plan to make individual participant data (IPD) available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhanguo Nie,Professor, Wulumuqi General Hospital of Lanzhou Military Command:
cold snare polypectomy
hot snare polypectomy
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Intestinal Polyps
Pathological Conditions, Anatomical