Biliary StrictureNCT05826639
A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions
An observational study of Biliary Stricture, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stricture
- What is being tested?
- Temperature-sensitive radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 18 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents.
Who may be able to join
- Malignant biliary stricture
- participants have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents
- Patients with life expectancy greater than 3 months
- Able to provide consent
Who cannot join
- Patients who are pregnant
- Patients with cirrhosis
- Patients with 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 stents or percutaneous drainage that cannot be removed at time of ERCP and thus preclude effective RFA
- Patients with altered anatomy unable to undergo conventional ERCP (i.e., history of Roux-en-Y gastric bypass)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Risks, Safety, and Outcomes of Temperature-sensitive Endobiliary Radiofrequency Ablation in Patients With Malignant Biliary Obstructions
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. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.
- Conditions
- Biliary Stricture
- Being tested
- Temperature-sensitive radiofrequency ablation, No intervention
- Keywords
- Bile duct obstruction, Biliary stent, Temperature-Sensitive Radiofrequency Ablation (RFA)
- Medical subject headings
- Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature-sensitive radiofrequency ablationProcedure or surgery
Also called RFA
Endobiliary radiofrequency ablation prior to ERCP-guided biliary stenting that utilizes a temperature-sensitive endobiliary RFA catheter
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Temperature-sensitive RFA prior to biliary stenting | Data will be collected on subjects undergoing endoscopic retrograde cholangiopancreatography (ERCP) with temperature-sensitive RFA prior to biliary stenting for treatment of malignant biliary strictures as part of clinical care. Receives: Procedure: Temperature-sensitive radiofrequency ablation | |
| Non-RFA biliary stenting for malignant biliary obstruction | Retrospective participants that have undergone non-RFA biliary stenting for malignant biliary obstruction from a historical cohort will serve as controls. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent patency
Duration of stent patency over the 6 month follow-up period
Measured: 6 months
Re-intervention free survival
Duration of re-intervention free survival over the 6 month follow-up period
Measured: 6 months
Mortality
Number of subject deaths following ERCP, over the 6-month follow-up period
Measured: 6 months
Secondary outcomes (2)
Adverse Events
Number of participants with treatment-related adverse events over the 6-month follow-up period
Measured: 6 months
Time until first adverse event
Time (in days) from ERCP until first treatment-related adverse event, over the 6-month follow-up period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start13 Apr 2023
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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-control
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinay Chandrasekhara, Mayo Clinic
- Investigators
- Vinay Chandrasekhara, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826639
- Sponsor's protocol ID
- 22-005206
- Other IDs
- NCI-2024-02188
- Status last verified
- Feb 2025
- First submitted
- 12 Apr 2023
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risks, Safety, and Outcomes of Temperature-sensitive Endobiliary Radiofrequency Ablation in Patients With Malignant Biliary Obstructions
- ClinicalTrials.gov ID
- NCT05826639
- Acronym / sponsor ID
- 22-005206
- Conditions
- Biliary Stricture
- Keywords
- Bile duct obstruction, Biliary stent, Temperature-Sensitive Radiofrequency Ablation (RFA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 24 Apr 2023 (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 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. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temperature-sensitive RFA prior to biliary stenting | – | Procedure: Temperature-sensitive radiofrequency ablationData will be collected on subjects undergoing endoscopic retrograde cholangiopancreatography (ERCP) with temperature-sensitive RFA prior to biliary stenting for treatment of malignant biliary strictures as part of clinical care. |
| Non-RFA biliary stenting for malignant biliary obstruction | – | Other: No interventionRetrospective participants that have undergone non-RFA biliary stenting for malignant biliary obstruction from a historical cohort will serve as controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents.
Key inclusion criteria (4 listed)
- Malignant biliary stricture
- participants have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents
- Patients with life expectancy greater than 3 months
- Able to provide consent
Key exclusion criteria (5 listed)
- Patients who are pregnant
- Patients with cirrhosis
- Patients with 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 stents or percutaneous drainage that cannot be removed at time of ERCP and thus preclude effective RFA
- Patients with altered anatomy unable to undergo conventional ERCP (i.e., history of Roux-en-Y gastric bypass)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature-sensitive radiofrequency ablationAlso: RFAEndobiliary radiofrequency ablation prior to ERCP-guided biliary stenting that utilizes a temperature-sensitive endobiliary RFA catheter | Procedure or surgery | Temperature-sensitive RFA prior to biliary stenting |
| No interventionNo intervention | Other | Non-RFA biliary stenting for malignant biliary obstruction |
Primary outcome
Stent patency
Time frame: 6 months
Duration of stent patency over the 6 month follow-up period
Re-intervention free survival
Time frame: 6 months
Duration of re-intervention free survival over the 6 month follow-up period
Mortality
Time frame: 6 months
Number of subject deaths following ERCP, over the 6-month follow-up period
2 secondary outcomes
Adverse Events
Time frame: 6 months
Time until first adverse event
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Biliary Stricture
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
Not yet recruiting
The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
Biliary Strictures Caused by Malignant Neoplasms
RecruitingPhase 2
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Primary Sclerosing Cholangitis, Liver Transplant, Complications
Recruiting
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
Biliary Obstruction, Bile Duct Stricture
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. This study is not recruiting at the moment.
Vinay Chandrasekhara, MD principal investigator
Mayo Clinic
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 Biliary Stricture, run by Mayo Clinic 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 27 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stent patency (time frame: 6 months). 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 27 Feb 2025.