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EUS-RFA: Endoscopic Ultrasound Radiofrequency Ablation, Database Repository

Sponsor
Indiana University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04693754
Collaborator
(none)
100
Enrollment
1
Location
126
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of having this database is to collect data related to endoscopic ultrasound RFA procedures performed by Indiana University EUS physicians for the treatment of tumors or adenopathy. This database is a repository database only, all information will be obtained in the electronic medical record. No additional clinical procedures will be performed outside current standard of care for endoscopic ultrasound. The patient will have already signed an informed consent for the endoscopic ultrasound. Subjects will be entered into the database for up to 10 years after the most recent procedure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Radiofrequency ablation (RFA) is a well-established therapeutic option for ablation of dysplastic and neoplastic tissue by the use of local thermal coagulative necrosis. Options for administration include percutaneous or a surgical approach. Percutaneous RFA is effective and safe, but it is unfeasible in cases of lesions with interposition of organs and/or vessels. For lesions such as the pancreas, surgery-assisted RFA has been described but requires general anesthesia and is associated with a substantial risk of thermal injuries to major vessels or adjacent structures.

    EUS-guided RFA is a minimally invasive approach that offers high-quality real-time imaging guidance during selective ablation of benign (1-5) or malignant (6-7) pancreatic lesions. Treatment in small case series has shown to produce local necrosis with minimal adverse events. Other sites treated include the liver and metastatic adenopathy.

    This database will collect data related to endoscopic ultrasound RFA procedures performed by Indiana University EUS physicians for the treatment of tumors or adenopathy. No additional clinical procedures will be performed outside current standard of care for endoscopic ultrasound. The patient's information collected will be pre-procedure identification of the adenopathy, labs, the endoscopic ultrasound(s) and post procedure follow up and care related to the adenopathy.

    Patients will be contacted by phone at post-procedure 1 & 2 weeks and asked to report symptoms related to the procedure.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Retrospective
    Official Title:
    Endoscopic Ultrasound Radiofrequency Ablation, Database Repository
    Actual Study Start Date :
    Jul 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of any procedural complications that occur during the procedure on date of procedure. [Day of procedure]

      This data will be used for to determine the clinical impact and safety of these procedures.

    2. Rate of patient report of symptoms related to procedure (Acute pancreatitis, abdominal pain, infection/abscess, venous thrombosis, & fever) [1 week following procedure]

      1 week phone follow up

    3. Rate of patient report of symptoms related to procedure (Acute pancreatitis, abdominal pain, infection/abscess, venous thrombosis, & fever) [2 weeks following procedure]

      2 week phone follow up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Subjects 14 years of age and older Referral for the treatment of a benign or malignant tumor or adenopathy

    Exclusion Criteria:
    • Subjects less than 14 years of age Unable to comprehend the study consent due to language or disability

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Health University Hospital Indianapolis Indiana United States 46202-5121

    Sponsors and Collaborators

    • Indiana University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John DeWitt, Principal Invstigator, Indiana University
    ClinicalTrials.gov Identifier:
    NCT04693754
    Other Study ID Numbers:
    • 2006385412
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Jan 25, 2022