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NCT Number: NCT07682805

STSC-HybridAPC Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Piecemeal endoscopic mucosal resection (EMR) of large (≥20 mm) non-pedunculated colorectal lesions was historically associated with local recurrence rates in the range of 15-20% at first surveillance when no systematic margin therapy was applied¹. The introduction of structured post-EMR margin thermal ablation has substantially altered this landscape. In a landmark randomized controlled trial, systematic thermal ablation of the resection margin reduced recurrence from 21% to 5%². Subsequent prospective and multicenter studies performed in high-volume expert centers using standardized circumferential snare-tip soft coagulation (STSC) protocols have demonstrated further reductions, with reported recurrence rates approaching 1-2%³. Most recently, Gauci et al. demonstrated that complete margin thermal ablation eliminates lesion size as a risk factor for recurrence following piecemeal EMR of large non-pedunculated colorectal polyps, reinforcing the durability and consistency of this approach in contemporary practice⁴. These findings are supported by meta-analytic data confirming that thermal margin ablation significantly reduces recurrence compared with no ablation without increasing clinically meaningful adverse events⁵. Accordingly, current international guidelines strongly recommend routine thermal ablation of the post-EMR mucosal defect margin following piecemeal resection of large colorectal lesions⁶.

Given that recurrence rates are now low when complete circumferential ablation is systematically performed, additional trials powered for recurrence would require prohibitively large sample sizes to detect incremental differences. The remaining clinically relevant gap therefore relates not to efficacy, but to procedural efficiency, reproducibility, and implementation, particularly in early-career or non-advanced interventional endoscopists.

Snare-tip soft coagulation requires precise contact-based application of thermal energy at each point sequentially along the entire resection margin, demanding consistent tip positioning and repeated fine manipulations. This technical precision may be particularly challenging for endoscopists with limited experience, increasing the risk of incomplete ablation or prolonged procedural time.

Hybrid APC (ERBE) delivers thermal energy via a non-contact argon plasma beam with a broader coagulation footprint per activation, potentially enabling faster and more reproducible circumferential coverage with fewer individual applications. The wider energy spread of Hybrid APC may therefore reduce operator-dependent variability and facilitate more consistent margin treatment, particularly in the hands of early-career endoscopists. Whether this translates into a meaningful reduction in net ablation time and improved completion rates compared with STSC has not been prospectively evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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).

Primary outcomes

  1. Net margin ablation time

    Time frame: during the procedure

    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.

Secondary outcomes

  1. Time (total)

    Time frame: during procedure

    Total procedure time (minutes): from first endoscopic view of the lesion to scope withdrawal.

  2. Technical success of margin ablation

    Time frame: during procedure

    Technical success of margin ablation: completion of circumferential thermal treatment of the entire visible mucosal defect margin as judged by the supervising endoscopist and recorded as yes/no.

  3. Instrument exchanges (count)

    Time frame: during procedure

    Instrument exchanges (count): number of device exchanges required after completion of EMR to achieve margin ablation.

  4. Need for additional haemostatic therapy (yes/no)

    Time frame: during procedure

    Need for additional haemostatic therapy (yes/no): including clips, APC outside assigned intervention, injectable agents, or other modalities used for bleeding control.

  5. Operator-rated ease of use (VAS 0-10)

    Time frame: during procedure

    Operator-rated ease of use (VAS 0-10): recorded immediately post-procedure (0 = very difficult, 10 = very easy)

  6. Operator confidence (VAS 0-10)

    Time frame: during procedure

    Operator confidence (VAS 0-10): confidence that ablation was complete (0 = not confident, 10 = fully confident).

  7. Immediate adverse events

    Time frame: during procedure

    Immediate adverse events: intraprocedural and early post-procedural events as per standard definitions (bleeding requiring endoscopic therapy, perforation, post-polypectomy syndrome, unplanned admission). Severity will be graded using an accepted endoscopy AE severity framework (e.g., ASGE lexicon).

  8. Cost impact (exploratory)

    Time frame: during procedure

    Cost impact (exploratory): incremental procedural cost derived from device utilization (snare tip vs Hybrid APC), number of exchanges, and additional haemostatic devices used.

  9. Rate of incomplete STSC margin ablation by trainee operators (yes/no, Arm A only)

    Time frame: during procedure

    Rate of incomplete STSC margin ablation by trainee operators (yes/no, Arm A only): proportion of Arm A cases in which the supervising endoscopist judged circumferential margin ablation to be incomplete at the conclusion of the trainee's attempt, necessitating supplementary ablation by the supervisor.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Goodrick, BN

CONTACT

[email protected]

+612 88905555

Mayan Eitan, MD

CONTACT

[email protected]

+612 88905555

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Official study title

Snare Tip Soft Coagulation Versus Hybrid APC (ERBE) for Post-EMR Margin Thermal Ablation - A Prospective Randomized Controlled Trial

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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