Back to resultsComplete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy
Primary Purpose
Colorectal Polyps
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Endoscopic mucosal resection
Conventional polypectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Polyps focused on measuring nonpedunculated, neoplastic, colorectal, polyps
Eligibility Criteria
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.
Sites / Locations
- Showa Inan General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional polypectomy
Endoscopic mucosal resection
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination.
Secondary Outcome Measures
Postpolypectomy bleeding requiring endoscopic intervention within two weeks after polypectomy
Full Information
NCT ID
NCT01950117
First Posted
September 21, 2013
Last Updated
November 2, 2014
Sponsor
Showa Inan General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01950117
Brief Title
Complete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyps
Keywords
nonpedunculated, neoplastic, colorectal, polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional polypectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Endoscopic mucosal resection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic mucosal resection
Intervention Description
Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected after submucosal injection of saline solution before removal.
Intervention Type
Procedure
Intervention Name(s)
Conventional polypectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Postpolypectomy bleeding requiring endoscopic intervention within two weeks after polypectomy
Time Frame
Two weeks
Other Pre-specified Outcome Measures:
Title
the procedure time
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Showa Inan General Hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4117
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Complete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy
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