Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

30 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Zim Warda Hasan
Numéro de téléphone: 364-203-1900
E-mail: zh00027@mix.wvu.edu

Lieux d'étude

États-Unis
- West Virginia
  - Morgantown, West Virginia, États-Unis, 26505
    - Recrutement
    - West Virginia University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

N/A

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change From Baseline to 1 Month in Target Lesion Size Délai: 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 Délai: 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 Délai: 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 Délai: Baseline to 12 months	Change in tumor size (cm) from baseline to 12 months, assessed by imaging.	Baseline to 12 months
Overall Survival Délai: 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 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Change From Baseline to 1 Month in Serum CA 19-9 Concentration Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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) Délai: 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) Délai: 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) Délai: 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) Délai: 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) Délai: 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) Délai: 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) Délai: 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) Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

West Virginia University

Les enquêteurs

Chercheur principal: Shailendra Singh, MD, West Virginia University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 mars 2026

Achèvement primaire (Estimé)

1 mars 2028

Achèvement de l'étude (Estimé)