Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps

NCT01369316 | Withdrawn

• 1 other identifier: EMR-002-CSI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon.

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

• Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)

  3 months

Study Arms (2)

Circumferential Submucosal Incision Resection

EXPERIMENTAL

Procedure: Circumferential Submucosal Incision Resection

Endoscopic Mucosal Resection

ACTIVE COMPARATOR

Patients randomised into this arm will receive the conventional treatment Endoscopic Mucosal Resection in which the sessile lesion is injected and snared by piecemeal technique.

Procedure: Endoscopic Mucosal Resection

Interventions

Circumferential Submucosal Incision Resection PROCEDURE

The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.

Circumferential Submucosal Incision Resection

Endoscopic Mucosal Resection PROCEDURE

Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed

Endoscopic Mucosal Resection

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Can give informed consent to trial participation
• Age greater than 18
• Adenomas that have not have previously been attempted for resection (i.e. naïve lesions)
• Adenoma size greater than 20 mm

You may not qualify if:

• Age less than 18
• Previous resection or attempted resection of target adenoma lesion
• Pregnant patients

Sponsors & Collaborators

• Professor Michael Bourke: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; 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 Officials

• Michael J Bourke

  Westmead Hospital - Endoscopy Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Michael Bourke

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 8, 2011
• Study Start: March 9, 2020
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)