- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07682805
STSC-HybridAPC Trial
Snare Tip Soft Coagulation Versus Hybrid APC (ERBE) for Post-EMR Margin Thermal Ablation - A Prospective Randomized Controlled Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Kathleen Goodrick, BN
- Telefonní číslo: +612 88905555
- E-mail: kathleen.goodrick@health.nsw.gov.au
Studijní záloha kontaktů
- Jméno: Mayan Eitan, MD
- Telefonní číslo: +612 88905555
- E-mail: mayan.eitan@health.nsw.gov.au
Studijní místa
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New South Wales
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Sydney, New South Wales, Austrálie, 2145
- Westmead Hospital
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Kontakt:
- Kathleen Goodrick, BN
- Telefonní číslo: +612 88905555
- E-mail: kathleen.goodrick@health.nsw.gov.au
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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.
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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.
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Aktivní komparátor: 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).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Net margin ablation time
Časové okno: during the procedure
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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.
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during the procedure
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time (total)
Časové okno: during procedure
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Total procedure time (minutes): from first endoscopic view of the lesion to scope withdrawal.
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during procedure
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Technical success of margin ablation
Časové okno: during procedure
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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.
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during procedure
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Instrument exchanges (count)
Časové okno: during procedure
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Instrument exchanges (count): number of device exchanges required after completion of EMR to achieve margin ablation.
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during procedure
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Need for additional haemostatic therapy (yes/no)
Časové okno: during procedure
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Need for additional haemostatic therapy (yes/no): including clips, APC outside assigned intervention, injectable agents, or other modalities used for bleeding control.
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during procedure
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Operator-rated ease of use (VAS 0-10)
Časové okno: during procedure
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Operator-rated ease of use (VAS 0-10): recorded immediately post-procedure (0 = very difficult, 10 = very easy)
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during procedure
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Operator confidence (VAS 0-10)
Časové okno: during procedure
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Operator confidence (VAS 0-10): confidence that ablation was complete (0 = not confident, 10 = fully confident).
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during procedure
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Immediate adverse events
Časové okno: during procedure
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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).
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during procedure
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Cost impact (exploratory)
Časové okno: during procedure
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Cost impact (exploratory): incremental procedural cost derived from device utilization (snare tip vs Hybrid APC), number of exchanges, and additional haemostatic devices used.
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during procedure
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Rate of incomplete STSC margin ablation by trainee operators (yes/no, Arm A only)
Časové okno: during procedure
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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.
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during procedure
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Michael J Bourke, MBBS, WSLHD
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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