Ablation Techniques, Gastrointestinal Lesions, Microwave Ablation, Pancreatic Lesion, RFA
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
West Virginia University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 1 Month in Target Lesion Size | Baseline to 1 month | Change in tumor size (cm) from baseline to 1 month, assessed by imaging. |
| Change From Baseline to 3 Months in Target Lesion Size | Baseline to 3 months | Change in tumor size (cm) from baseline to 3 months, assessed by imaging. |
| Change From Baseline to 6 Months in Target Lesion Size | Baseline to 6 months | Change in tumor size (cm) from baseline to 6 months, assessed by imaging. |
| Change From Baseline to 12 Months in Target Lesion Size | Baseline to 12 months | Change in tumor size (cm) from baseline to 12 months, assessed by imaging. |
| Overall Survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 1 Month in Serum CA 19-9 Concentration | Baseline to 1 month | Change in serum CA 19-9 concentration from baseline to 1 month. |
| Change From Baseline to 3 Month in Serum CA 19-9 Concentration | Baseline to 3 month | Change in serum CA 19-9 concentration from baseline to 3 month. |
| Change From Baseline to 6 Month in Serum CA 19-9 Concentration | Baseline to 6 month | Change in serum CA 19-9 concentration from baseline to 6 month. |
| Change From Baseline to 12 Month in Serum CA 19-9 Concentration | Baseline to 12 month | Change in serum CA 19-9 concentration from baseline to 12 month. |
| Change From Baseline to 1 Month in Serum CEA Concentration | Baseline to 1 month | Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 1 month. |
| Change From Baseline to 3 Month in Serum CEA Concentration | Baseline to 3 month | Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 3 month. |
| Change From Baseline to 6 Month in Serum CEA Concentration | Baseline to 6 month | Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 6 month. |
| Change From Baseline to 12 Month in Serum CEA Concentration | Baseline to 12 month | Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 12 month. |
| Change From Baseline to 1 Month in Size of Non-Target Lesions | Baseline to 1 month | Change in size (cm) of non-target lesions from baseline to 1 month, assessed by imaging. |
| Change From Baseline to 3 Months in Size of Non-Target Lesions | Baseline to 3 months | Change in size (cm) of non-target lesions from baseline to 3 months, assessed by imaging. |
| Change From Baseline to 6 Months in Size of Non-Target Lesions | Baseline to 6 months | Change in size (cm) of non-target lesions from baseline to 6 months, assessed by imaging. |
| Change From Baseline to 12 Months in Size of Non-Target Lesions | Baseline to 12 months | Change in size (cm) of non-target lesions from baseline to 12 months, assessed by imaging. |
| Number of Participants With Procedure-Related Adverse Events (1 Month) | 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. |
| Number of Participants With Procedure-Related Adverse Events (3 Months) | 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. |
| Number of Participants With Procedure-Related Adverse Events (6 Months) | 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. |
| Number of Participants With Procedure-Related Adverse Events (12 Months) | 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. |
| Change From Baseline to 1 Month in Quality of Life Score (EORTC QLQ-C30) | 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. |
| Change From Baseline to 3 Month in Quality of Life Score (EORTC QLQ-C30) | 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. |
| Change From Baseline to 6 Month in Quality of Life Score (EORTC QLQ-C30) | 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. |
| Change From Baseline to 12 Month in Quality of Life Score (EORTC QLQ-C30) | 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. |
Countries
United States
Contacts
CONTACTZim Warda Hasan
PRINCIPAL_INVESTIGATORShailendra Singh, MD
West Virginia University
Outcome results
None listed