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STSC-HybridAPC Trial

26 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

140

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Comparatore attivo: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Net margin ablation time
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time (total)
Lasso di tempo: during procedure
Total procedure time (minutes): from first endoscopic view of the lesion to scope withdrawal.
during procedure
Technical success of margin ablation
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: during procedure
Operator confidence (VAS 0-10): confidence that ablation was complete (0 = not confident, 10 = fully confident).
during procedure
Immediate adverse events
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Michael J Bourke, MBBS, WSLHD

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

15 agosto 2027

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2026/PID01713

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Adenomi del colon

Prove cliniche su Snare Tip Soft Coagulation (STSC)

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