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

NCT01950117 | Completed

• 1 other identifier: EMR vs. polypectomy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Colorectal Polyps

Keywords

nonpedunculated; neoplastic; colorectal; polyps

Outcome Measures

Primary Outcomes (1)

• The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination.

  Two weeks

Secondary Outcomes (1)

• Postpolypectomy bleeding requiring endoscopic intervention within two weeks after polypectomy

  Two weeks

Other Outcomes (1)

• the procedure time

  One day

Study Arms (2)

Conventional polypectomy

ACTIVE COMPARATOR

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

Endoscopic mucosal resection

EXPERIMENTAL

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

Interventions

Endoscopic mucosal resection PROCEDURE

Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected after submucosal injection of saline solution before removal.

Endoscopic mucosal resection

Conventional polypectomy PROCEDURE

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.

Conventional polypectomy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Location

MeSH Terms

Conditions

Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Digestive Disease Center

Study Record Dates

• First Submitted: September 21, 2013
• First Posted: September 25, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

JP (1)