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.
Study Type
OBSERVATIONAL
Enrollment
50
West Virginia University
Morgantown, West Virginia, United States
RECRUITINGChange 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 month
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 months
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 months
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 months
Overall Survival
Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up.
Time frame: From ablation to death or last follow-up, assessed up to 1 year
Overall Survival
Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up.
Time frame: From ablation to death or last follow-up, assessed up to 3 year
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 month
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 month
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 month
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 month
Change From Baseline to 1 Month in Serum CEA Concentration
Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 1 month.
Time frame: Baseline to 1 month
Change From Baseline to 3 Month in Serum CEA Concentration
Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 3 month.
Time frame: Baseline to 3 month
Change From Baseline to 6 Month in Serum CEA Concentration
Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 6 month.
Time frame: Baseline to 6 month
Change From Baseline to 12 Month in Serum CEA Concentration
Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 12 month.
Time frame: Baseline to 12 month
Change From Baseline to 1 Month in Size of Non-Target Lesions
Change in size (cm) of non-target lesions from baseline to 1 month, assessed by imaging.
Time frame: Baseline to 1 month
Change From Baseline to 3 Months in Size of Non-Target Lesions
Change in size (cm) of non-target lesions from baseline to 3 months, assessed by imaging.
Time frame: Baseline to 3 months
Change From Baseline to 6 Months in Size of Non-Target Lesions
Change in size (cm) of non-target lesions from baseline to 6 months, assessed by imaging.
Time frame: Baseline to 6 months
Change From Baseline to 12 Months in Size of Non-Target Lesions
Change in size (cm) of non-target lesions from baseline to 12 months, assessed by imaging.
Time frame: Baseline to 12 months
Number of Participants With Procedure-Related Adverse Events (1 Month)
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.
Time frame: Up to 1 month after ablation procedure
Number of Participants With Procedure-Related Adverse Events (3 Months)
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.
Time frame: Up to 3 months after ablation procedure
Number of Participants With Procedure-Related Adverse Events (6 Months)
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.
Time frame: Up to 6 months after ablation procedure
Number of Participants With Procedure-Related Adverse Events (12 Months)
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.
Time frame: Up to 12 months after ablation procedure
Change From Baseline to 1 Month in Quality of Life Score (EORTC QLQ-C30)
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.
Time frame: Baseline to 1 month
Change From Baseline to 3 Month in Quality of Life Score (EORTC QLQ-C30)
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.
Time frame: Baseline to 3 month
Change From Baseline to 6 Month in Quality of Life Score (EORTC QLQ-C30)
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.
Time frame: Baseline to 6 month
Change From Baseline to 12 Month in Quality of Life Score (EORTC QLQ-C30)
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.
Time frame: Baseline to 12 month
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