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OpenTrials
Enrolling by Invitation

NCT Number: NCT04693754

Endoscopic Ultrasound Radiofrequency Ablation, Database Repository

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.

Enrolling by Invitation

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202-5121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 2 weeks following procedure

    2 week phone follow up

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: EUS-RFA

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jan 5, 2021
Registry last updated
Feb 18, 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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