Soft Coagulation for the Prevention of Adenoma Recurrence

NCT ID: NCT01789749

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

455 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-12-16

Brief Summary

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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.

Detailed Description

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Conditions

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Colonic Adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.

Study Groups

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No Coagulation Arm

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

Group Type ACTIVE_COMPARATOR

No Snare Tip Soft Coagulation

Intervention Type OTHER

Coagulation Arm

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

Group Type EXPERIMENTAL

Snare Tip Soft Coagulation

Intervention Type OTHER

Interventions

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Snare Tip Soft Coagulation

Intervention Type OTHER

No Snare Tip Soft Coagulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Professor Michael Bourke

OTHER

Sponsor Role lead

Responsible Party

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Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Bourke, FRACP, MBBS

Role: PRINCIPAL_INVESTIGATOR

Western SLHD

Locations

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Westmead Endoscopy Unit

Westmead, New South Wales, Australia

Site Status

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Site Status

Lyell McEwin Hospital

Adelaide, South Australia, Australia

Site Status

The Alfred Hospital

Melbourne, VA, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 30296436 (View on PubMed)

Other Identifiers

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HREC2012/5/4.6 (3512)

Identifier Type: OTHER

Identifier Source: secondary_id

HREC/12/WMEAD/139

Identifier Type: -

Identifier Source: org_study_id

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