EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWest Virginia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change From Baseline to 1 Month in Target Lesion Size
Change in tumor size (cm) from baseline to 1 month, assessed by imaging.
Time frame
Baseline to 1 month2
Change From Baseline to 3 Months in Target Lesion Size
Change in tumor size (cm) from baseline to 3 months, assessed by imaging.
Time frame
Baseline to 3 months3
Change From Baseline to 6 Months in Target Lesion Size
Change in tumor size (cm) from baseline to 6 months, assessed by imaging.
Time frame
Baseline to 6 months4
Change From Baseline to 12 Months in Target Lesion Size
Change in tumor size (cm) from baseline to 12 months, assessed by imaging.
Time frame
Baseline to 12 monthsSecondary outcomes
1
Change From Baseline to 1 Month in Serum CA 19-9 Concentration
Change in serum CA 19-9 concentration from baseline to 1 month.
Time frame
Baseline to 1 month2
Change From Baseline to 3 Month in Serum CA 19-9 Concentration
Change in serum CA 19-9 concentration from baseline to 3 month.
Time frame
Baseline to 3 month3
Change From Baseline to 6 Month in Serum CA 19-9 Concentration
Change in serum CA 19-9 concentration from baseline to 6 month.
Time frame
Baseline to 6 month4
Change From Baseline to 12 Month in Serum CA 19-9 Concentration
Change in serum CA 19-9 concentration from baseline to 12 month.
Time frame
Baseline to 12 monthSponsors and contacts
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Source ClinicalTrials.gov