EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions Registry
30 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
De observación
Inscripción (Estimado)
50
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zim Warda Hasan
- Número de teléfono: 364-203-1900
- Correo electrónico: zh00027@mix.wvu.edu
Ubicaciones de estudio
-
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West Virginia
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Morgantown, West Virginia, Estados Unidos, 26505
- Reclutamiento
- West Virginia University
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
N/A
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline to 1 Month in Target Lesion Size
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 12 months
|
Change in tumor size (cm) from baseline to 12 months, assessed by imaging.
|
Baseline to 12 months
|
|
Overall Survival
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline to 1 Month in Serum CA 19-9 Concentration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 12 month
|
Change in serum CA 19-9 concentration from baseline to 12 month.
|
Baseline to 12 month
|
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Change From Baseline to 1 Month in Serum CEA Concentration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 1 month
|
Change in size (cm) of non-target lesions from baseline to 1 month, assessed by imaging.
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Baseline to 1 month
|
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Change From Baseline to 3 Months in Size of Non-Target Lesions
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 12 months
|
Change in size (cm) of non-target lesions from baseline to 12 months, assessed by imaging.
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Baseline to 12 months
|
|
Number of Participants With Procedure-Related Adverse Events (1 Month)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Up to 6 months after ablation procedure
|
|
Number of Participants With Procedure-Related Adverse Events (12 Months)
Periodo de tiempo: 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.
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Up to 12 months after ablation procedure
|
|
Change From Baseline to 1 Month in Quality of Life Score (EORTC QLQ-C30)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Shailendra Singh, MD, West Virginia University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Robles-Medranda C, Arevalo-Mora M, Oleas R, Alcivar-Vasquez J, Del Valle R. Novel EUS-guided microwave ablation of an unresectable pancreatic neuroendocrine tumor. VideoGIE. 2022 Jan 19;7(2):74-76. doi: 10.1016/j.vgie.2021.10.009. eCollection 2022 Feb.
- Wood LD, Canto MI, Jaffee EM, Simeone DM. Pancreatic Cancer: Pathogenesis, Screening, Diagnosis, and Treatment. Gastroenterology. 2022 Aug;163(2):386-402.e1. doi: 10.1053/j.gastro.2022.03.056. Epub 2022 Apr 7.
- Wray CJ, O'Brien B, Cen P, Rowe JH, Faraoni EY, Bailey JM, Rubin E, Tammisetti VS, Thosani N. EUS-guided radiofrequency ablation for pancreatic adenocarcinoma. Gastrointest Endosc. 2024 Oct;100(4):759-766. doi: 10.1016/j.gie.2024.04.2926. Epub 2024 May 8.
- Kongkam P, Tantitanawat K, Kerr S, Lopimpisuth C, Tiankanon K, Angsuwatcharakon P, Ridtitid W, Mekaroonkamol P, Teeyapun N, Tanasanvimon S, Treeprasertsuk S, Kullavanijaya P, Sriuranpong V, Rerknimitr R, Luangsukrerk T. One-year survival rate of unresectable pancreatic cancer size 4 cm or smaller treated with or without EUS-radiofrequency ablation. Gastrointest Endosc. 2025 Dec;102(6):883-887. doi: 10.1016/j.gie.2025.06.008. Epub 2025 Jul 17.
- Bidani K, Marinovic AG, Moond V, Harne P, Broder A, Thosani N. Treatment of Pancreatic Neuroendocrine Tumors: Beyond Traditional Surgery and Targeted Therapy. J Clin Med. 2025 May 13;14(10):3389. doi: 10.3390/jcm14103389.
- Mohan A, Prasanth M, Saeed NA, Shehzadi T, Hasan ZW, Khan NN, Tanush D, Aminpoor H. Advancements in endoscopic closure techniques for gastrointestinal luminal defects comparative perspectives on OTSC, endo suturing, TTS clips, and X-Tack. Ann Med Surg (Lond). 2025 Jul 16;87(8):5077-5086. doi: 10.1097/MS9.0000000000003571. eCollection 2025 Aug.
- Hasan ZW, Shehzadi T, Mohan A, Rehman AU, Muskan F, Zia M, Lal PM, Aminpoor H, Karimi H, Kumar V, Tejwaney U, Kumar S. Percutaneous, transpapillary, and transmural drainage in acute cholecystitis: a comparative analysis of techniques, stent selection, and clinical. Ann Med Surg (Lond). 2025 Jul 30;87(8):5056-5061. doi: 10.1097/MS9.0000000000003527. eCollection 2025 Aug.
- Slodkowski M, Wronski M, Karkocha D, Kraj L, Smigielska K, Jachnis A. Current Approaches for the Curative-Intent Surgical Treatment of Pancreatic Ductal Adenocarcinoma. Cancers (Basel). 2023 Apr 30;15(9):2584. doi: 10.3390/cancers15092584.
- Rahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas. 2025 Jul 1;54(6):e530-e536. doi: 10.1097/MPA.0000000000002489.
- Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021 Sep 7;326(9):851-862. doi: 10.1001/jama.2021.13027.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de marzo de 2026
Finalización primaria (Estimado)
1 de marzo de 2028
Finalización del estudio (Estimado)
1 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
2 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- STUDY00000041
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .