Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

30. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

Vereinigte Staaten
- West Virginia
  - Morgantown, West Virginia, Vereinigte Staaten, 26505
    - Rekrutierung
    - West Virginia University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

N/A

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change From Baseline to 1 Month in Target Lesion Size Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: Baseline to 12 months	Change in tumor size (cm) from baseline to 12 months, assessed by imaging.	Baseline to 12 months
Overall Survival Zeitfenster: 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 Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change From Baseline to 1 Month in Serum CA 19-9 Concentration Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

West Virginia University

Ermittler

Hauptermittler: Shailendra Singh, MD, West Virginia University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. März 2026

Primärer Abschluss (Geschätzt)

1. März 2028

Studienabschluss (Geschätzt)