Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT)
Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT Study)
The purpose of this study is to evaluate whether endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) affects survival in patients with inoperable pancreatic carcinoma. By using a prospective single-arm design with historical controls, this study aims to generate clinically relevant data while minimizing the number of patients exposed to experimental treatment. The findings may support future integration of EUS-RFA into standard care for this high-need patient population.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Clara Søndersted, MD
- Número de telefone: 45 38683868
- E-mail: clara.theodora.soendersted@regionh.dk
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adult habile patients with a signed informed consent
- Histologically confirmed pancreatic carcinoma ≤5 cm in largest diameter
- ECOG performance status 0-2
- Patients not eligible for curative-intended surgical treatment due to:
Advanced (unresectable) disease, or Unsuitability for surgery due to comorbidities or poor performance status, or Patient preference to decline surgery
Exclusion Criteria:
- Metastatic disease
- Uncorrected coagulopathy (INR ≥1.5 or thrombocyte count < 50 mia/L)
- Altered anatomy or interposition of major vessels precluding safe EUS-RFA
- Active untreated infection or pancreatitis
- Life expectancy <3 months
- Prior local ablative treatment interfering with outcome
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: EUS-RFA plus standard oncological treatment
Participants receive endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using a 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) connected to an RF generator, as a supplement to standard palliative oncological treatment. EUS-RFA is performed under deep sedation or general anesthesia and may be repeated at approximately 4-week intervals contingent on patient condition. All participants continue standard oncological follow-up, including systemic therapy and regular cross-sectional imaging, in parallel with the study intervention. |
A 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) is introduced through the working channel of an echoendoscope and advanced into the pancreatic tumor under real-time ultrasound guidance. The needle is connected to a dedicated RF generator delivering a current of 400-500 kHz, which induces coagulative necrosis in the targeted tissue. Treatment is continued until complete ablation is confirmed ultrasonographically, or until an impedance value of 800 Ω is reached, at which point the generator automatically terminates power output to limit further tissue damage. A cooling pump circulates chilled saline through the needle to reduce charring at the ablation site. The procedure is performed transgastrically or transduodenally under deep sedation or general anesthesia, and may involve one or more ablation cycles per session. Treatment may be repeated at approximately 4-week intervals, depending on radiological response and patient tolerance.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall survival
Prazo: From index date until death from any cause, assessed up to 4 years
|
Time from index date (first day of systemic oncological therapy or first visit at the Department of Oncology (for patients who do not receive systemic therapy)) to death from any cause. Participants alive at the time of last follow-up will be censored at that date. |
From index date until death from any cause, assessed up to 4 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression- and metastatic-free survival
Prazo: From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years
|
Time from index date to radiological progression of the primary tumor or development of distant metastases, assessed according to RECIST 1.1 on cross-sectional imaging. |
From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years
|
|
Local tumor control at 6 and 12 months
Prazo: At 6 and 12 months after index date
|
Proportion of participants with local tumor control (absence of local progression) on cross-sectional imaging at 6 and 12 months, assessed according to RECIST 1.1. |
At 6 and 12 months after index date
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Procedure-related adverse events
Prazo: At 30 days after each EUS-RFA procedure
|
Adverse events occurring within 30 days of each EUS-RFA treatment, graded according to the AGREE classification. |
At 30 days after each EUS-RFA procedure
|
|
Time to biliary/duodenal intervention
Prazo: From index date until intervention or last follow-up, assessed up to approximately 4 years
|
Time from index date to first biliary or duodenal intervention (e.g., stenting) |
From index date until intervention or last follow-up, assessed up to approximately 4 years
|
|
Pain score change compared to baseline
Prazo: Baseline and at 6, 12 and 18 months after inclusion
|
Change from baseline in pain severity, measured using a Numeric Rating Scale (NRS, 0-10) |
Baseline and at 6, 12 and 18 months after inclusion
|
|
Opioid consumption change compared to baseline
Prazo: Baseline and at 6, 12 and 18 months after inclusion
|
Change in opioid consumption, converted to total daily oral morphine milligram equivalent (MME). |
Baseline and at 6, 12 and 18 months after inclusion
|
|
Quality of Life change compared to baseline (EORTC QLQ-C30)
Prazo: Baseline and at 6, 12 and 18 months
|
Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Global Health Status/Quality of Life scale, ranging from 0 (worst) to 100 (best), with higher scores indicating better quality of life. |
Baseline and at 6, 12 and 18 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bojan Kovacevic, MD, PhD, Herlev Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 16-0302-148
Plano para dados de participantes individuais (IPD)
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