Endoscopic Ultrasound Radiofrequency Ablation, Database Repository

Pancreatic Neoplasm Clinical Trial

— EUS-RFA  

Official title:

Endoscopic Ultrasound Radiofrequency Ablation, Database Repository

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04693754
• Other study ID #: 2006385412
• Status: Enrolling by invitation
• Start date: July 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

Locations

Country	Name	City	State
United States	Indiana University Health University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day of procedure
Primary	Rate of patient report of symptoms related to procedure (Acute pancreatitis, abdominal pain, infection/abscess, venous thrombosis, & fever)	1 week phone follow up	1 week following procedure
Primary	Rate of patient report of symptoms related to procedure (Acute pancreatitis, abdominal pain, infection/abscess, venous thrombosis, & fever)	2 week phone follow up	2 weeks following procedure