NCT02198729

Brief Summary

The investigators have recently become proficient in a new, and we believe more effective technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves removing the polyp in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. There have also been recent studies overseas that have shown this new technique to be quite effective. In this study, half of the patients will receive the newly developed technique of polyp removal (ESD), while the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment. This study will allow us to show which technique results in lower recurrence rates and is more effective.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

July 17, 2014

Last Update Submit

March 25, 2025

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations

    18 months

Secondary Outcomes (4)

  • One piece resection rate

    14 days

  • Technical success of EMR

    14 days

  • Recurrence

    up to 3 years

  • complication rates

    14 days

Study Arms (2)

Endoscopic Mucosal Resection

ACTIVE COMPARATOR

Participants randomised to this arm will receive standard of care Endoscopic Mucosal Resection for removal of their lesions.

Procedure: Endoscopic Mucosal Resection

Endoscopic Submucosal Dissection

EXPERIMENTAL

Participants randomised to this arm will receive Endoscopic Mucosal Dissection to remove their lesion.

Procedure: Endoscopic Submucosal Dissection

Interventions

Endoscopic Submucosal DissectionPROCEDURE
Endoscopic Submucosal Dissection
Endoscopic Mucosal ResectionPROCEDURE
Endoscopic Mucosal Resection

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can give informed consent to trial participation
  • Lesion size 20 mm to 50 mm
  • Laterally spreading or sessile polyp morphology

You may not qualify if:

  • Previous resection or attempted resection of target adenoma lesion
  • Endoscopic appearance of invasive malignancy
  • Age less than 18 years
  • Pregnancy
  • Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
  • Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
  • American Society of Anesthesiology (ASA) Grade IV-V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location

Related Publications (1)

  • O'Sullivan T, Tate D, Sidhu M, Gupta S, Elhindi J, Byth K, Cronin O, Whitfield A, Craciun A, Singh R, Brown G, Raftopoulos S, Hourigan L, Moss A, Klein A, Heitman S, Williams S, Lee E, Burgess NG, Bourke MJ. The Surface Morphology of Large Nonpedunculated Colonic Polyps Predicts Synchronous Large Lesions. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2270-2277.e1. doi: 10.1016/j.cgh.2023.01.034. Epub 2023 Feb 12.

    PMID: 36787836DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Michael J Bourke, MBBS

    Western Sydney Local Health District

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 24, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)