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

30. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Zim Warda Hasan
Telefonnummer: 364-203-1900
E-post: zh00027@mix.wvu.edu

Studiesteder

Forente stater
- West Virginia
  - Morgantown, West Virginia, Forente stater, 26505
    - Rekruttering
    - West Virginia University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change From Baseline to 1 Month in Target Lesion Size Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: Baseline to 12 months	Change in tumor size (cm) from baseline to 12 months, assessed by imaging.	Baseline to 12 months
Overall Survival Tidsramme: 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 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change From Baseline to 1 Month in Serum CA 19-9 Concentration Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

West Virginia University

Etterforskere

Hovedetterforsker: Shailendra Singh, MD, West Virginia University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. mars 2026

Primær fullføring (Antatt)

1. mars 2028

Studiet fullført (Antatt)