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STSC-HybridAPC Trial

26 juni 2026 bijgewerkt door: Professor Michael Bourke, Western Sydney Local Health District

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

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Snare Tip Soft Coagulation (STSC)
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.
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.
Actieve vergelijker: Hybrid APC (ERBE)
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).
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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Net margin ablation time
Tijdsspanne: 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.
during the procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time (total)
Tijdsspanne: during procedure
Total procedure time (minutes): from first endoscopic view of the lesion to scope withdrawal.
during procedure
Technical success of margin ablation
Tijdsspanne: 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.
during procedure
Instrument exchanges (count)
Tijdsspanne: during procedure
Instrument exchanges (count): number of device exchanges required after completion of EMR to achieve margin ablation.
during procedure
Need for additional haemostatic therapy (yes/no)
Tijdsspanne: during procedure
Need for additional haemostatic therapy (yes/no): including clips, APC outside assigned intervention, injectable agents, or other modalities used for bleeding control.
during procedure
Operator-rated ease of use (VAS 0-10)
Tijdsspanne: during procedure
Operator-rated ease of use (VAS 0-10): recorded immediately post-procedure (0 = very difficult, 10 = very easy)
during procedure
Operator confidence (VAS 0-10)
Tijdsspanne: during procedure
Operator confidence (VAS 0-10): confidence that ablation was complete (0 = not confident, 10 = fully confident).
during procedure
Immediate adverse events
Tijdsspanne: 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).
during procedure
Cost impact (exploratory)
Tijdsspanne: 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.
during procedure
Rate of incomplete STSC margin ablation by trainee operators (yes/no, Arm A only)
Tijdsspanne: 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.
during procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Michael J Bourke, MBBS, WSLHD

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

15 augustus 2027

Studieregistratiedata

Eerst ingediend

26 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2026/PID01713

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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