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

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ClinicalTrials.gov Identifier: NCT01950117
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital

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)


Condition or disease Intervention/treatment Phase
Colorectal Polyps Procedure: Endoscopic mucosal resection Procedure: Conventional polypectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.




Primary Outcome Measures :
  1. The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination. [ Time Frame: Two weeks ]

Secondary Outcome Measures :
  1. Postpolypectomy bleeding requiring endoscopic intervention within two weeks after polypectomy [ Time Frame: Two weeks ]

Other Outcome Measures:
  1. the procedure time [ Time Frame: One day ]


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT01950117


Locations
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Japan
Showa Inan General Hospital
Komagane, Nagano, Japan, 399-4117
Sponsors and Collaborators
Showa Inan General Hospital

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Responsible Party: Akira Horiuchi, Chief, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT01950117    
Other Study ID Numbers: EMR vs. polypectomy
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
Keywords provided by Akira Horiuchi, Showa Inan General Hospital:
nonpedunculated
neoplastic
colorectal
polyps
Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical
Pharmaceutical Solutions