Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps (CSIEMR)

June 28, 2023 updated by: Professor Michael Bourke

Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Resection for the Removal of Large Laterally Spreading Tumours and Sessile Polyps of the Colon

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The investigators have recently developed a new, and the investigators believe safer and more effective technique for endoscopic mucosal resection (EMR). Utilising the new method the investigators make small cuts around the polyp to isolate it. Subsequently the Gelofusine solution is injected beneath the polyp and provides greater elevation. This allows us to improve the chance of removal of the entire polyp with one attempt in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. Our team has recently completed an animal study comparing our newly developed technique to conventional EMR. The investigators have found significant improvements in our ability to completely remove the polyp in one attempt. There have also been recent studies overseas that have shown this new technique to be quite effective.

Study Type

Interventional

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 Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
        • Contact:
        • Principal Investigator:
          • Michael J Bourke
        • Principal Investigator:
          • Farzan Fartash
        • Sub-Investigator:
          • Stephen J Williams
        • Sub-Investigator:
          • Alan Moss

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

16 years to 93 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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
Experimental: Circumferential Submucosal Incision Resection
Procedure: Circumferential Submucosal Incision Resection
The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.
Active Comparator: Endoscopic Mucosal Resection
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
Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Professor Michael Bourke

Investigators

  • Principal Investigator: Michael J Bourke, Westmead Hospital - Endoscopy Unit

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 (Estimated)

December 30, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimated)

June 8, 2011

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR-002-CSI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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