NCT02957058

Brief Summary

To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with thermal treatment applied to the defect margin. The primary aim of the study will be to ensure the safety of this approach and there will be constant monitoring to ensure that this is the case.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

November 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

November 3, 2016

Last Update Submit

March 25, 2025

Conditions

Colonic AdenomaColonic Polyp

Keywords

ColonoscopyEndoscopic Mucosal ResectionAdenoma RecurrenceEMR defect thermal ablation

Outcome Measures

Primary Outcomes (1)

  • Adenoma recurrence

    Recurrence of adenoma at first and second surveillance colonoscopy

    Variable dependent on SERT score

Secondary Outcomes (4)

  • Need for surgery

    18 months

  • Bleeding after EMR

    2 weeks

  • Pain after EMR

    2 weeks

  • Delayed perforation after EMR

    2 weeks

Study Arms (2)

SERT 0, SCAR (low risk)

ACTIVE COMPARATOR

Patients with Sydney EMR Recurrence Tool (SERT scoring) score 0. These patients will be invited to return for follow up at 18 months and will have thermal ablation (SCAR technique) of the endoscopic resection defect margin.

Procedure: SCAR technique

SERT 1-4, SCAR (high risk)

ACTIVE COMPARATOR

Patients with Sydney EMR Recurrence Tool score 1-4 (SERT scoring). These patients will be invited to return for follow up at 4-6 months and will have thermal ablation (SCAR technique) of the endoscopic resection defect margin.

Procedure: SCAR technique

Interventions

SCAR techniquePROCEDURE

Thermal ablation of the EMR margin using ERBE Soft Coagulation (Effect 4, 80 watts) and the operator choice of endoscopic resection snare

SERT 0, SCAR (low risk)SERT 1-4, SCAR (high risk)

Eligibility Criteria

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

You may qualify if:

  • All laterally spreading lesions \>= 20mm referred to the named tertiary referral centres
  • Must consent to involvement

You may not qualify if:

  • Histology other than specified
  • Lesion involving the ileocaecal valve
  • Pregnancy: currently pregnant or attempting to become pregnant
  • Lactation: currently breastfeeding
  • Taken clopidogrel within 7 days
  • Taken warfarin within 5 days
  • Had full therapeutic dose unfractionated heparin within 6 hours
  • Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
  • Known clotting disorder
  • Previous attempt at EMR of the polyp referred for resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Related Publications (1)

  • Sidhu M, Shahidi N, Gupta S, Desomer L, Vosko S, Arnout van Hattem W, Hourigan LF, Lee EYT, Moss A, Raftopoulos S, Heitman SJ, Williams SJ, Zanati S, Tate DJ, Burgess N, Bourke MJ. Outcomes of Thermal Ablation of the Mucosal Defect Margin After Endoscopic Mucosal Resection: A Prospective, International, Multicenter Trial of 1000 Large Nonpedunculated Colorectal Polyps. Gastroenterology. 2021 Jul;161(1):163-170.e3. doi: 10.1053/j.gastro.2021.03.044. Epub 2021 Mar 31.

    PMID: 33798525DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Medicine

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 7, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2022

Study Completion

April 1, 2023

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)