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NCT Number: NCT07625189

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

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.

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Key information

Conditions

RFA Ablation Techniques Gastrointestinal Lesions Microwave Ablation Pancreatic Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Virginia University

Morgantown, West Virginia, 26505, United States

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change From Baseline to 1 Month in Target Lesion Size

    Time frame: Baseline to 1 month

    Change in tumor size (cm) from baseline to 1 month, assessed by imaging.

  2. Change From Baseline to 3 Months in Target Lesion Size

    Time frame: Baseline to 3 months

    Change in tumor size (cm) from baseline to 3 months, assessed by imaging.

  3. Change From Baseline to 6 Months in Target Lesion Size

    Time frame: Baseline to 6 months

    Change in tumor size (cm) from baseline to 6 months, assessed by imaging.

  4. Change From Baseline to 12 Months in Target Lesion Size

    Time frame: Baseline to 12 months

    Change in tumor size (cm) from baseline to 12 months, assessed by imaging.

  5. Overall Survival

    Time frame: 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.

  6. Overall Survival

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline to 1 Month in Serum CA 19-9 Concentration

    Time frame: Baseline to 1 month

    Change in serum CA 19-9 concentration from baseline to 1 month.

  2. Change From Baseline to 3 Month in Serum CA 19-9 Concentration

    Time frame: Baseline to 3 month

    Change in serum CA 19-9 concentration from baseline to 3 month.

  3. Change From Baseline to 6 Month in Serum CA 19-9 Concentration

    Time frame: Baseline to 6 month

    Change in serum CA 19-9 concentration from baseline to 6 month.

  4. Change From Baseline to 12 Month in Serum CA 19-9 Concentration

    Time frame: Baseline to 12 month

    Change in serum CA 19-9 concentration from baseline to 12 month.

  5. Change From Baseline to 1 Month in Serum CEA Concentration

    Time frame: Baseline to 1 month

    Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 1 month.

  6. Change From Baseline to 3 Month in Serum CEA Concentration

    Time frame: Baseline to 3 month

    Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 3 month.

  7. Change From Baseline to 6 Month in Serum CEA Concentration

    Time frame: Baseline to 6 month

    Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 6 month.

  8. Change From Baseline to 12 Month in Serum CEA Concentration

    Time frame: Baseline to 12 month

    Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 12 month.

  9. Change From Baseline to 1 Month in Size of Non-Target Lesions

    Time frame: Baseline to 1 month

    Change in size (cm) of non-target lesions from baseline to 1 month, assessed by imaging.

  10. Change From Baseline to 3 Months in Size of Non-Target Lesions

    Time frame: Baseline to 3 months

    Change in size (cm) of non-target lesions from baseline to 3 months, assessed by imaging.

  11. Change From Baseline to 6 Months in Size of Non-Target Lesions

    Time frame: Baseline to 6 months

    Change in size (cm) of non-target lesions from baseline to 6 months, assessed by imaging.

  12. Change From Baseline to 12 Months in Size of Non-Target Lesions

    Time frame: Baseline to 12 months

    Change in size (cm) of non-target lesions from baseline to 12 months, assessed by imaging.

  13. Number of Participants With Procedure-Related Adverse Events (1 Month)

    Time frame: 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.

  14. Number of Participants With Procedure-Related Adverse Events (3 Months)

    Time frame: 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.

  15. Number of Participants With Procedure-Related Adverse Events (6 Months)

    Time frame: 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.

  16. Number of Participants With Procedure-Related Adverse Events (12 Months)

    Time frame: 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.

  17. Change From Baseline to 1 Month in Quality of Life Score (EORTC QLQ-C30)

    Time frame: 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.

  18. Change From Baseline to 3 Month in Quality of Life Score (EORTC QLQ-C30)

    Time frame: 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.

  19. Change From Baseline to 6 Month in Quality of Life Score (EORTC QLQ-C30)

    Time frame: 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.

  20. Change From Baseline to 12 Month in Quality of Life Score (EORTC QLQ-C30)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zim Warda Hasan

CONTACT

[email protected]

364-203-1900

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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