Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

30 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Zim Warda Hasan
Numero di telefono: 364-203-1900
Email: zh00027@mix.wvu.edu

Luoghi di studio

Stati Uniti
- West Virginia
  - Morgantown, West Virginia, Stati Uniti, 26505
    - Reclutamento
    - West Virginia University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change From Baseline to 1 Month in Target Lesion Size Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: Baseline to 12 months	Change in tumor size (cm) from baseline to 12 months, assessed by imaging.	Baseline to 12 months
Overall Survival Lasso di tempo: 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 Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change From Baseline to 1 Month in Serum CA 19-9 Concentration Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

West Virginia University

Investigatori

Investigatore principale: Shailendra Singh, MD, West Virginia University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 marzo 2026

Completamento primario (Stimato)

1 marzo 2028

Completamento dello studio (Stimato)