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STSC-HybridAPC Trial

26 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

140

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Comparador Ativo: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Net margin ablation time
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time (total)
Prazo: during procedure
Total procedure time (minutes): from first endoscopic view of the lesion to scope withdrawal.
during procedure
Technical success of margin ablation
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: during procedure
Operator confidence (VAS 0-10): confidence that ablation was complete (0 = not confident, 10 = fully confident).
during procedure
Immediate adverse events
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Michael J Bourke, MBBS, WSLHD

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de janeiro de 2027

Conclusão Primária (Estimado)

1 de agosto de 2027

Conclusão do estudo (Estimado)

15 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

26 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de junho de 2026

Primeira postagem (Real)

6 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2026/PID01713

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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