NCT07682805

Brief Summary

Margin thermal ablation after piecemeal EMR significantly reduces recurrence of large colorectal polyps. As recurrence rates are now low, the key implementation question relates to efficiency and reproducibility of different ablation techniques. This randomized controlled trial compares snare tip soft coagulation (STSC) with Hybrid APC (ERBE), with procedural time as the primary endpoint.

Trial Health

63
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Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2027

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 26, 2026

Last Update Submit

June 26, 2026

Conditions

Colon AdenomasColon Adenomatous Polyp

Outcome Measures

Primary Outcomes (1)

  • Net margin ablation time

    Net margin ablation time (seconds), defined as the elapsed time from the first application of thermal energy to the resection margin (first activation in soft coagulation mode) until the operator declares completion of circumferential margin ablation. Time will be recorded using a standardized stopwatch method by a trained assistant/nurse (or captured from time-stamped video, if available). Interruptions unrelated to margin ablation (e.g., equipment troubleshooting) will be documented and excluded from net time where feasible, with sensitivity analyses planned.

    during the procedure

Secondary Outcomes (9)

  • Time (total)

    during procedure

  • Technical success of margin ablation

    during procedure

  • Instrument exchanges (count)

    during procedure

  • Need for additional haemostatic therapy (yes/no)

    during procedure

  • Operator-rated ease of use (VAS 0-10)

    during procedure

  • +4 more secondary outcomes

Study Arms (2)

Snare Tip Soft Coagulation (STSC)

ACTIVE COMPARATOR

Circumferential thermal ablation of the resection margin will be performed using the distal tip of a standard polypectomy snare in soft coagulation mode. The tip will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment.

Procedure: Snare Tip Soft Coagulation (STSC)

Hybrid APC (ERBE)

ACTIVE COMPARATOR

Circumferential thermal ablation of the resection margin will be performed using Hybrid APC (ERBE) in standard APC mode. The argon plasma beam will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment. Electrosurgical settings will be standardized according to unit protocol (effect and wattage predefined for Hybrid APC use).

Procedure: Hybrid APC (ERBE)

Interventions

Snare Tip Soft Coagulation (STSC)PROCEDURE

Circumferential thermal ablation of the resection margin will be performed using the distal tip of a standard polypectomy snare in soft coagulation mode. The tip will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment.

Snare Tip Soft Coagulation (STSC)
Hybrid APC (ERBE)PROCEDURE

Circumferential thermal ablation of the resection margin will be performed using Hybrid APC (ERBE) in standard APC mode. The argon plasma beam will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment. Electrosurgical settings will be standardized according to unit protocol (effect and wattage predefined for Hybrid APC use).

Hybrid APC (ERBE)

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Undergoing piecemeal EMR of a non-pedunculated colorectal lesion ≥20 mm in size
  • Macroscopically complete resection achieved prior to margin ablation (no visible residual adenomatous tissue at the resection base)
  • Ability to provide written informed consent

You may not qualify if:

  • Lesions requiring en bloc resection by ESD
  • Lesions with suspected deep submucosal invasion based on endoscopic assessment (e.g., depressed morphology, non-lifting sign, NICE type 3 pattern, or equivalent advanced imaging criteria)
  • Inflammatory bowel disease with active colitis at the lesion site
  • Overt invasive carcinoma requiring surgical management
  • Pregnancy
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Related Publications (3)

  • Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26.

    PMID: 38670139BACKGROUND

  • Gauci JL, Mandarino FV, Kerrison C, Whitfield AM, O'Sullivan T, Gupta S, Lam B, Perananthan V, Cronin O, Lee EY, Williams SJ, Burgess N, Bourke MJ. Margin thermal ablation eliminates size as a risk factor for recurrence after piecemeal endoscopic mucosal resection of large non-pedunculated colorectal polyps. Gut. 2025 Apr 7;74(5):752-760. doi: 10.1136/gutjnl-2024-333563.

    PMID: 40044497BACKGROUND

  • Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.

    PMID: 24671869BACKGROUND

Study Officials

  • Michael J Bourke, MBBS

    WSLHD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Goodrick, BN

CONTACT

+612 88905555kathleen.goodrick@health.nsw.gov.au

Mayan Eitan, MD

CONTACT

+612 88905555mayan.eitan@health.nsw.gov.au

Study Design

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

Study Record Dates

First Submitted

June 26, 2026

First Posted

July 6, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 15, 2027

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)