Impact Of Temperature-sensitive Radiofrequency Ablation In Patients With Malignant Biliary Obstructions Undergoing Biliary Stenting
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-005206
NCT ID: NCT05826639
Sponsor Protocol Number: 22-005206
About this study
The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. Additionally, to describe the incidence of adverse events with combination RFA plus stenting.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults >18 years old with malignant biliary stricture.
- Biopsy-confirmed intraductal malignancy.
- Patients with life expectancy greater than 3 months.
Exclusion Criteria:
- Age < 18 years of age.
- Patients who are pregnant, have cirrhosis, or significant liver metastasis >30% on radiologic imaging suggestive of poor liver function that will not improve despite endoscopic drainage.
- Patients who have undergone prior biliary decompression with endoscopic biliary stenting or percutaneous drainage.
- Inability to traverse duodenum to reach papilla.
Eligibility last updated 8/24/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available