Anastomotic StenosisNCT03229655
Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation
A study testing Protocol for increasing number of stents across the anastomosis in people with Anastomotic Stenosis and Biliary Stricture, run by Stanford University at 1 site in United States.
Trial summary
Prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Stenosis, Biliary Stricture
- What is being tested?
- Protocol for increasing number of stents across the anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 and older
- Clinical concern for anastomotic biliary stricture following liver transplantation (as determined by the referring transplant hepatologist)
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Who cannot join
- Age <18
- Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- Complex post-surgical anatomy e.g. Choledochojejunostomy, Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
- Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. significant non-anastomotic biliary stricture).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stanford University Medical Center
Stanford, California, 94305
Subhas Banerjee, MD, 650-723-2623, sbanerje@stanford.edu
About this study
Prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation.
- Conditions
- Anastomotic Stenosis, Biliary Stricture
- Being tested
- Protocol for increasing number of stents across the anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol for increasing number of stents across the anastomosisProcedure or surgery
Sequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed.
| Study group | Role | What they receive |
|---|---|---|
| Sequential stent addition | Experimental | ERCP with sphincterotomy and stent placement is initially performed, then additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation. Receives: Procedure: Protocol for increasing number of stents across the anastomosis |
| Incremental Dilation & Stent Exchange | Active comparator | ERCP with sphincterotomy and stent placement is initially performed, with subsequent ERCPs involving removal of previously placed stents, stricture dilation and balloon sweeps to extract stone debris/sludge. Receives: Procedure: Protocol for increasing number of stents across the anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic biliary stricture resolution
Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed
Measured: Immediately following final ERCP with stent removal
Secondary outcomes (4)
Fluoroscopy Parameters
Fluoroscopy Time per fluoroscopy machine output
Measured: 1 day
Adverse Events
Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure
Measured: 1 week
Sustained resolution of anastomotic stricture for 6 months
No evidence of recurrent stricture based on clinical status and laboratory studies
Measured: 6 months after final study ERCP with stent removal
Sustained resolution of anastomotic stricture for 12 months
No evidence of recurrent stricture based on clinical status and laboratory studies
Measured: 12 months after final study ERCP with stent removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic StenosisStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, University of Barcelona
- Responsible party
- Principal investigator, Subhas Banerjee, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229655
- Sponsor's protocol ID
- 41606
- Status last verified
- Sep 2018
- First submitted
- 30 Jun 2017
- Last updated
- 11 Sep 2018
- 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 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation
- ClinicalTrials.gov ID
- NCT03229655
- Acronym / sponsor ID
- 41606
- Conditions
- Anastomotic Stenosis, Biliary Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Rochester, University of Barcelona
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 25 Jul 2017 (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.
Prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| Sequential stent addition | Experimental | Procedure: Protocol for increasing number of stents across the anastomosisERCP with sphincterotomy and stent placement is initially performed, then additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation. |
| Incremental Dilation & Stent Exchange | Active comparator | Procedure: Protocol for increasing number of stents across the anastomosisERCP with sphincterotomy and stent placement is initially performed, with subsequent ERCPs involving removal of previously placed stents, stricture dilation and balloon sweeps to extract stone debris/sludge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- Clinical concern for anastomotic biliary stricture following liver transplantation (as determined by the referring transplant hepatologist)
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Age <18
- Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- Complex post-surgical anatomy e.g. Choledochojejunostomy, Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
- Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. significant non-anastomotic biliary stricture).
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 |
|---|---|---|
| Protocol for increasing number of stents across the anastomosisSequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed. | Procedure or surgery | Incremental Dilation & Stent Exchange, Sequential stent addition |
Primary outcome
Anastomotic biliary stricture resolution
Time frame: Immediately following final ERCP with stent removal
Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed
4 secondary outcomes
Fluoroscopy Parameters
Time frame: 1 day
Adverse Events
Time frame: 1 week
Sustained resolution of anastomotic stricture for 6 months
Time frame: 6 months after final study ERCP with stent removal
Sustained resolution of anastomotic stricture for 12 months
Time frame: 12 months after final study ERCP with stent removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol for increasing number of stents across the anastomosis in people with Anastomotic Stenosis and Biliary Stricture, run by Stanford 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 3 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: status not confirmed, as of the sponsor's last update on 11 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Subhas Banerjee, MD (650-723-2623, sbanerje@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic biliary stricture resolution (time frame: Immediately following final ERCP with stent removal). 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 11 Sep 2018.