Complete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy

November 2, 2014 updated by: Akira Horiuchi, Showa Inan General Hospital

Recently, it was reported that the incomplete resection rate of neoplastic large polyps after conventional polypectomy was markedly high in clinical practice. The incomplete resection rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known.

The aim of this study is to compare the incomplete resection rate of neoplastic large polyps after EMR or conventional polypectomy. The EMR technique is preferable to conventional polypectomy for the complete resection of the large polyps (>15 mm in diameter)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagano
      • Komagane, Nagano, Japan, 399-4117
        • Showa Inan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria were nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter.

Exclusion Criteria:

  • less than 20 years old, history of previous colorectal surgical resection, American Society of Anesthesiologists class III and IV, allergic to propofol used or its components (soybeans or eggs), or poor bowel preparation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional polypectomy
Colorectal polyps from 10 mm to 25 mm was found. Submucosal injection of saline solution before removal was not performed for polypectomy. The snare used for polypectomy was a dual loop wire snare with a loop size of 33/16 mm (SN-3316LX, Medico's Hirata Inc., Osaka, Japan). An ERBE ICC200 (Amco, Tokyo, Japan) was used in the Endocut mode with the effect 3 current set at output limit 120W and forced coagulation current set at output limit 35W for conventional polypectomy. Prophylactic clipping after polyp removal was routinely performed.
Procedure: Conventional polypectomy
Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected using conventional polypectomy. Submucosal injection of saline solution before removal was not performed.
Experimental: Endoscopic mucosal resection
Colorectal polyp from 10 mm to 25 mm was found. Submucosal injection of saline solution before removal was performed for EMR. The snare used for EMR was a dual loop wire snare with a loop size of 33/16 mm (SN-3316LX, Medico's Hirata Inc., Osaka, Japan). An ERBE ICC200 (Amco, Tokyo, Japan) was used in the Endocut mode with the effect 3 current set at output limit 120W and forced coagulation current set at output limit 35W for EMR. Prophylactic clipping after polyp removal was routinely performed.
Procedure: Endoscopic mucosal resection
Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected after submucosal injection of saline solution before removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination.
Time Frame: Two weeks
Two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Postpolypectomy bleeding requiring endoscopic intervention within two weeks after polypectomy
Time Frame: Two weeks
Two weeks

Other Outcome Measures

Outcome Measure
Time Frame
the procedure time
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Showa Inan General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 21, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 2, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR vs. polypectomy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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