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EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions Registry

30 de maio de 2026 atualizado por: Shailendra Singh, West Virginia University

Prospective Observational Registry of EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions

This is a single-center, investigator-initiated, prospective observational registry that will collect longitudinal clinical data on adult patients (≥18 years) undergoing endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) or microwave ablation (MWA) for pancreatic and other gastrointestinal/hepatobiliary lesions as part of routine clinical care. The registry will not alter standard-of-care management. Data will be abstracted from the medical record and routine clinical systems. Primary outcomes include change in target lesion size on clinically obtained imaging and overall survival following ablation. Secondary outcomes include changes in tumor biomarkers, adverse events, non-target lesion changes, and patient-reported symptoms.

Visão geral do estudo

Status

Recrutamento

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

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

Nome: Zim Warda Hasan
Número de telefone: 364-203-1900
E-mail: zh00027@mix.wvu.edu

Locais de estudo

Estados Unidos
- West Virginia
  - Morgantown, West Virginia, Estados Unidos, 26505
    - Recrutamento
    - West Virginia University

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

N/D

Método de amostragem

Amostra Não Probabilística

População do estudo

The purpose of this registry is to create a longitudinal clinical dataset describing patients who undergo EUS-guided RFA or MWA as part of routine care and to explore clinical outcomes and factors associated with those outcomes.

Descrição

Inclusion Criteria:

Adults ≥ 18 years of age.
Diagnosis of a pancreatic premalignant lesion or malignancy, and other gastrointestinal or hepatobiliary lesion for which EUS-guided ablation is planned as part of standard clinical care.
At least one clinically identified target lesion for which RFA or MWA is performed.

Exclusion Criteria:

In the judgment of the treating clinician, inclusion in the registry would not be appropriate
The individual is expected to be unable to complete routine clinical follow-up.

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change From Baseline to 1 Month in Target Lesion Size Prazo: Baseline to 1 month	Change in tumor size (cm) from baseline to 1 month, assessed by imaging.	Baseline to 1 month
Change From Baseline to 3 Months in Target Lesion Size Prazo: Baseline to 3 months	Change in tumor size (cm) from baseline to 3 months, assessed by imaging.	Baseline to 3 months
Change From Baseline to 6 Months in Target Lesion Size Prazo: Baseline to 6 months	Change in tumor size (cm) from baseline to 6 months, assessed by imaging.	Baseline to 6 months
Change From Baseline to 12 Months in Target Lesion Size Prazo: Baseline to 12 months	Change in tumor size (cm) from baseline to 12 months, assessed by imaging.	Baseline to 12 months
Overall Survival Prazo: From ablation to death or last follow-up, assessed up to 1 year	Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up.	From ablation to death or last follow-up, assessed up to 1 year
Overall Survival Prazo: From ablation to death or last follow-up, assessed up to 3 year	Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up.	From ablation to death or last follow-up, assessed up to 3 year

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change From Baseline to 1 Month in Serum CA 19-9 Concentration Prazo: Baseline to 1 month	Change in serum CA 19-9 concentration from baseline to 1 month.	Baseline to 1 month
Change From Baseline to 3 Month in Serum CA 19-9 Concentration Prazo: Baseline to 3 month	Change in serum CA 19-9 concentration from baseline to 3 month.	Baseline to 3 month
Change From Baseline to 6 Month in Serum CA 19-9 Concentration Prazo: Baseline to 6 month	Change in serum CA 19-9 concentration from baseline to 6 month.	Baseline to 6 month
Change From Baseline to 12 Month in Serum CA 19-9 Concentration Prazo: Baseline to 12 month	Change in serum CA 19-9 concentration from baseline to 12 month.	Baseline to 12 month
Change From Baseline to 1 Month in Serum CEA Concentration Prazo: Baseline to 1 month	Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 1 month.	Baseline to 1 month
Change From Baseline to 3 Month in Serum CEA Concentration Prazo: Baseline to 3 month	Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 3 month.	Baseline to 3 month
Change From Baseline to 6 Month in Serum CEA Concentration Prazo: Baseline to 6 month	Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 6 month.	Baseline to 6 month
Change From Baseline to 12 Month in Serum CEA Concentration Prazo: Baseline to 12 month	Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 12 month.	Baseline to 12 month
Change From Baseline to 1 Month in Size of Non-Target Lesions Prazo: Baseline to 1 month	Change in size (cm) of non-target lesions from baseline to 1 month, assessed by imaging.	Baseline to 1 month
Change From Baseline to 3 Months in Size of Non-Target Lesions Prazo: Baseline to 3 months	Change in size (cm) of non-target lesions from baseline to 3 months, assessed by imaging.	Baseline to 3 months
Change From Baseline to 6 Months in Size of Non-Target Lesions Prazo: Baseline to 6 months	Change in size (cm) of non-target lesions from baseline to 6 months, assessed by imaging.	Baseline to 6 months
Change From Baseline to 12 Months in Size of Non-Target Lesions Prazo: Baseline to 12 months	Change in size (cm) of non-target lesions from baseline to 12 months, assessed by imaging.	Baseline to 12 months
Number of Participants With Procedure-Related Adverse Events (1 Month) Prazo: Up to 1 month after ablation procedure	Number of participants experiencing one or more procedure-related adverse events within 1 month after ablation. Adverse events will be assessed according to standard criteria.	Up to 1 month after ablation procedure
Number of Participants With Procedure-Related Adverse Events (3 Months) Prazo: Up to 3 months after ablation procedure	Number of participants experiencing one or more procedure-related adverse events within 3 months after ablation. Adverse events will be assessed according to standard criteria.	Up to 3 months after ablation procedure
Number of Participants With Procedure-Related Adverse Events (6 Months) Prazo: Up to 6 months after ablation procedure	Number of participants experiencing one or more procedure-related adverse events within 6 months after ablation. Adverse events will be assessed according to standard criteria.	Up to 6 months after ablation procedure
Number of Participants With Procedure-Related Adverse Events (12 Months) Prazo: Up to 12 months after ablation procedure	Number of participants experiencing one or more procedure-related adverse events within 12 months after ablation. Adverse events will be assessed according to standard criteria.	Up to 12 months after ablation procedure
Change From Baseline to 1 Month in Quality of Life Score (EORTC QLQ-C30) Prazo: Baseline to 1 month	Change in overall quality of life score from baseline to 1 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life.	Baseline to 1 month
Change From Baseline to 3 Month in Quality of Life Score (EORTC QLQ-C30) Prazo: Baseline to 3 month	Change in overall quality of life score from baseline to 3 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life.	Baseline to 3 month
Change From Baseline to 6 Month in Quality of Life Score (EORTC QLQ-C30) Prazo: Baseline to 6 month	Change in overall quality of life score from baseline to 6 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life.	Baseline to 6 month
Change From Baseline to 12 Month in Quality of Life Score (EORTC QLQ-C30) Prazo: Baseline to 12 month	Change in overall quality of life score from baseline to 12 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life.	Baseline to 12 month

Colaboradores e Investigadores

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

Patrocinador

West Virginia University

Investigadores

Investigador principal: Shailendra Singh, MD, West Virginia University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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 (Real)

10 de março de 2026

Conclusão Primária (Estimado)

1 de março de 2028

Conclusão do estudo (Estimado)