NCT01789749

Brief Summary

Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) \>= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
455

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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 28, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2016

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

November 28, 2012

Last Update Submit

March 22, 2021

Conditions

Colonic Adenomas

Keywords

snare tip soft coagulationendoscopic mucosal resectionadenoma recurrenceadenomacolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Endoscopic recurrence

    Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up

    4-6 months and 18 months

Secondary Outcomes (11)

  • Histologic recurrence

    4-6 months and 18 months

  • En bloc resection

    Index procedure

  • Snare resections

    Index procedure

  • Duration

    Index procedure

  • Perforation during EMR

    During index procedure

  • +6 more secondary outcomes

Study Arms (2)

No Coagulation Arm

ACTIVE COMPARATOR

Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Other: No Snare Tip Soft Coagulation

Coagulation Arm

EXPERIMENTAL

Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Other: Snare Tip Soft Coagulation

Interventions

Snare Tip Soft CoagulationOTHER
Coagulation Arm
No Snare Tip Soft CoagulationOTHER
No Coagulation Arm

Eligibility Criteria

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

You may qualify if:

  • Referred for removal of a colonic polyp \>= 20mm in size
  • Able to give informed consent to involvement in trial

You may not qualify if:

  • Younger than 18 years of age
  • Highly dependant on medical care
  • Women who are pregnant or may be pregnant.
  • 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
  • Polyp located at the ileo-caecal valve, appendiceal orifice
  • Fully circumferential polyp
  • Incomplete snare resection of the polyp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Location

Lyell McEwin Hospital

Adelaide, South Australia, Australia

Location

The Alfred Hospital

Melbourne, VA, Australia

Location

Related Publications (1)

  • Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6.

    PMID: 30296436DERIVED

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Michael Bourke, FRACP, MBBS

    Western SLHD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

November 28, 2012

First Posted

February 12, 2013

Study Start

July 1, 2013

Primary Completion

May 16, 2016

Study Completion

December 16, 2016

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

AU(4)