Pancreatic NeoplasmEUS-RFANCT04693754
Endoscopic Ultrasound Radiofrequency Ablation, Database Repository
An observational study of Pancreatic Neoplasm, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pancreatic Neoplasm
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Above 14 years of age and referred for treatment of benign or malignant tumor or adenopathy
Who may be able to join
- Subjects 14 years of age and older Referral for the treatment of a benign or malignant tumor or adenopathy
Who cannot join
- Subjects less than 14 years of age Unable to comprehend the study consent due to language or disability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University Health University Hospital
Indianapolis, Indiana, 46202-5121
About this study
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.
Read the 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.
- Conditions
- Pancreatic Neoplasm
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any procedural complications that occur during the procedure on date of procedure.
This data will be used for to determine the clinical impact and safety of these procedures.
Measured: Day of procedure
Rate of patient report of symptoms related to procedure (Acute pancreatitis, abdominal pain, infection/abscess, venous thrombosis, & fever)
1 week phone follow up
Measured: 1 week following procedure
Rate of patient report of symptoms related to procedure (Acute pancreatitis, abdominal pain, infection/abscess, venous thrombosis, & fever)
2 week phone follow up
Measured: 2 weeks following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jul 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John DeWitt, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693754
- Sponsor's protocol ID
- 2006385412
- Acronym
- EUS-RFA
- Status last verified
- Feb 2026
- First submitted
- 16 Jul 2020
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Radiofrequency Ablation, Database Repository
- ClinicalTrials.gov ID
- NCT04693754
- Acronym / sponsor ID
- EUS-RFA / 2006385412
- Conditions
- Pancreatic Neoplasm
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Above 14 years of age and referred for treatment of benign or malignant tumor or adenopathy
Key inclusion criteria (1 listed)
- Subjects 14 years of age and older Referral for the treatment of a benign or malignant tumor or adenopathy
Key exclusion criteria (1 listed)
- Subjects less than 14 years of age Unable to comprehend the study consent due to language or disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasm, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any procedural complications that occur during the procedure on date of procedure. (time frame: Day of procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.