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

30 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

50

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • West Virginia
      • Morgantown, West Virginia, Verenigde Staten, 26505
        • Werving
        • West Virginia University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

NVT

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline to 1 Month in Target Lesion Size
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 12 months
Change in tumor size (cm) from baseline to 12 months, assessed by imaging.
Baseline to 12 months
Overall Survival
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline to 1 Month in Serum CA 19-9 Concentration
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

West Virginia University

Onderzoekers

  • Hoofdonderzoeker: Shailendra Singh, MD, West Virginia University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 maart 2026

Primaire voltooiing (Geschat)

1 maart 2028

Studie voltooiing (Geschat)

1 maart 2028

Studieregistratiedata

Eerst ingediend

2 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 mei 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

30 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • STUDY00000041

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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