Bile LeakNCT03333382
Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks
A study testing Plastic biliary stent and FCSEMS in people with Bile Leak, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Standard endoscopic management for anastomotic bile leaks following OLT has been endoscopic retrograde cholangiopancreatography (ERCP) with placement of a temporary plastic biliary endoprosthesis (stent) across the site of anastomotic leak. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Leak
- What is being tested?
- Plastic biliary stent and FCSEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 21 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- adult patients undergoing ERCP for suspected anastomotic bile leak within 60 days following OLT with standard biliary reconstruction
- cognitively impaired population with a surrogate who has legal power of attorney
Who cannot join
- patients who have undergone OLT with hepaticojejunostomy
- patients who have undergone percutaneous transhepatic cholangiogram with percutaneous biliary intervention following OLT and prior to ERCP
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks Following Orthotopic Liver Transplant (OLT): a Randomized Controlled Trial
Standard endoscopic management for anastomotic bile leaks following OLT has been endoscopic retrograde cholangiopancreatography (ERCP) with placement of a temporary plastic biliary endoprosthesis (stent) across the site of anastomotic leak. While this intervention carries a high rate of technical success, clinical success is not universal. An alternative to placement of a plastic biliary stent is placement of a fully covered self-expanding metal stent (FCSEMS). Whereas a plastic stent functions largely as a wick to siphon bile flow, the theoretical advantage of a FCSEMS is that the relatively larger expansile diameter and membrane coating provide an actual and effective seal at the site of leak. FCSEMS have been used successfully for salvage therapy of anastomotic bile leaks in the post-OLT population with no serious stent related adverse events and no cases of unsuccessful FCSEMS removal in this population.
The objective of this study is to prospectively randomize patients found to have anastomotic bile leaks following OLT to placement of either a plastic biliary stent or a FCSEMS at initial ERCP intervention.
- Conditions
- Bile Leak
- Being tested
- Plastic biliary stent, FCSEMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plastic biliary stentDevice
Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.
FCSEMSDevice
FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.
| Study group | Role | What they receive |
|---|---|---|
| Plastic Biliary Stent | Active comparator | Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary plastic biliary stent placed across the site of the leak during retrograde cholangiopancreatography (ERCP). Receives: Device: Plastic biliary stent |
| FCSEMS | Active comparator | Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary fully covered self-expanding metal stent (FCSEMS) placed across the site of the leak during retrograde cholangiopancreatography (ERCP). Receives: Device: FCSEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholangiographic Resolution of Bile Leak at Follow-up ECRP
Adjudication of the primary study endpoint will be determined by the presence/absence of persistent anastomotic bile leak at first follow-up endoscopic retrograde cholangiopancreatography (ERCP) after initial stent placement, whether performed at 6 weeks or sooner.
Measured: up to 6 weeks
Secondary outcomes (9)
Need for Repeat Endoscopic Intervention (ERCP) Within Initial 8 Weeks Following Placement of a Plastic Stent or FCSEMS
Analysis for need of repeat endoscopic intervention (ERCP) within initial 8 weeks following placement of a plastic stent or FCSEMS will be completed.
Measured: 8 weeks
Need for Percutaneous Drainage of Biloma or Intraabdominal Fluid Collection Following Placement of a Plastic Stent or FCSEMS
Participants will be analyzed regarding need for percutaneous drainage of biloma or intraabdominal fluid collection following placement of a plastic stent or FCSEMS.
Measured: 90 days
Need for Surgical Biliary Reconstruction for Refractory Anastomotic Bile Leak
Participants will be analyzed for need of surgical biliary reconstruction for refractory anastomotic bile leak
Measured: 90 days
Need for Repeat OLT
Analysis for of need for orthotopic liver transplant (OLT) will be completed.
Measured: 90 days
Death at 90 Days
Participants will be followed and chart review will be completed to see if death occurred within 90 days.
Measured: 90 days
Rate of Post-ERCP Pancreatitis (PEP) Following Placement of a Plastic Stent vs FCSEMS
Analysis will be performed to determine rate of post-ERCP pancreatitis (PEP) following placement of a plastic stent vs FCSEMS.
Measured: 90 days
Rate of Stent Migration Following Placement of a Plastic Stent vs FCSEMS
Analysis will be performed to determine the rate of stent migration following placement of a plastic stent vs FCSEMS.
Measured: 90 days
Rate of Anastomotic Biliary Stricture at Follow-up ERCP 8 Weeks Following Placement of a Plastic Stent or FCSEMS
Rate of anastomotic biliary stricture at follow-up ERCP 8 weeks following placement of a plastic stent or FCSEMS will be analyzed during the course of the study.
Measured: 8 weeks
Need for Repeat ERCP for Management of Anastomotic Biliary Stricture Within 90 Days Following Leak Resolution
Participants will be analyzed for need of repeat ERCP for management of anastomotic biliary stricture within 90 days following leak resolution.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start30 Jan 2018
- Primary completion21 Aug 2018
- Study completion21 Sep 2020
Why it stopped: Post transplant leaks are now less frequent at VUMC and we struggled to enroll.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bile LeakStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Yachimski, Vanderbilt University Medical Center
- Investigators
- Patrick Yachimski, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333382
- Sponsor's protocol ID
- 171573
- Status last verified
- Mar 2022
- First submitted
- 31 Oct 2017
- Last updated
- 7 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks Following Orthotopic Liver Transplant (OLT): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03333382
- Acronym / sponsor ID
- 171573
- Conditions
- Bile Leak
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Post transplant leaks are now less frequent at VUMC and we struggled to enroll.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 7 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Standard endoscopic management for anastomotic bile leaks following OLT has been endoscopic retrograde cholangiopancreatography (ERCP) with placement of a temporary plastic biliary endoprosthesis (stent) across the site of anastomotic leak. While this intervention carries a high rate of technical success, clinical success is not universal. An alternative to placement of a plastic biliary stent is placement of a fully covered self-expanding metal stent (FCSEMS). Whereas a plastic stent functions largely as a wick to siphon bile flow, the theoretical advantage of a FCSEMS is that the relatively larger expansile diameter and membrane coating provide an actual and effective seal at the site of leak. FCSEMS have been used successfully for salvage therapy of anastomotic bile leaks in the post-OLT population with no serious stent related adverse events and no cases of unsuccessful FCSEMS removal in this population.
The objective of this study is to prospectively randomize patients found to have anastomotic bile leaks following OLT to placement of either a plastic biliary stent or a FCSEMS at initial ERCP intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic Biliary Stent | Active comparator | Device: Plastic biliary stentSubjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary plastic biliary stent placed across the site of the leak during retrograde cholangiopancreatography (ERCP). |
| FCSEMS | Active comparator | Device: FCSEMSSubjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary fully covered self-expanding metal stent (FCSEMS) placed across the site of the leak during retrograde cholangiopancreatography (ERCP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients undergoing ERCP for suspected anastomotic bile leak within 60 days following OLT with standard biliary reconstruction
- cognitively impaired population with a surrogate who has legal power of attorney
Key exclusion criteria (2 listed)
- patients who have undergone OLT with hepaticojejunostomy
- patients who have undergone percutaneous transhepatic cholangiogram with percutaneous biliary intervention following OLT and prior to ERCP
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 |
|---|---|---|
| Plastic biliary stentPlastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak. | Device | Plastic Biliary Stent |
| FCSEMSFCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak. | Device | FCSEMS |
Primary outcome
Cholangiographic Resolution of Bile Leak at Follow-up ECRP
Time frame: up to 6 weeks
Adjudication of the primary study endpoint will be determined by the presence/absence of persistent anastomotic bile leak at first follow-up endoscopic retrograde cholangiopancreatography (ERCP) after initial stent placement, whether performed at 6 weeks or sooner.
9 secondary outcomes
Need for Repeat Endoscopic Intervention (ERCP) Within Initial 8 Weeks Following Placement of a Plastic Stent or FCSEMS
Time frame: 8 weeks
Need for Percutaneous Drainage of Biloma or Intraabdominal Fluid Collection Following Placement of a Plastic Stent or FCSEMS
Time frame: 90 days
Need for Surgical Biliary Reconstruction for Refractory Anastomotic Bile Leak
Time frame: 90 days
Need for Repeat OLT
Time frame: 90 days
Death at 90 Days
Time frame: 90 days
Rate of Post-ERCP Pancreatitis (PEP) Following Placement of a Plastic Stent vs FCSEMS
Time frame: 90 days
Rate of Stent Migration Following Placement of a Plastic Stent vs FCSEMS
Time frame: 90 days
Rate of Anastomotic Biliary Stricture at Follow-up ERCP 8 Weeks Following Placement of a Plastic Stent or FCSEMS
Time frame: 8 weeks
Need for Repeat ERCP for Management of Anastomotic Biliary Stricture Within 90 Days Following Leak Resolution
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bile Leak
Recruiting
Prevention of Bile Leakage After Liver Resection in Children
Postoperative Bile Leak, Focal Liver Lesions
Not yet recruiting
Routine White Test for Early Detection of Bile Leak in Elective Liver Resection (DELiveR Trial)
Bile Leak, Liver Resection
Not yet recruiting
Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice
Obstructive Jaundice, Pancreatic Head Cancer
Active, not recruitingObservational study
The Need for Repeat ERCP After Endoscopic Treatment of Postsurgical Biliary Leaks
Bile Leak
Not yet recruitingPhase 2
Organoids for Bile Leaks
Biliary Anastomosis Complication
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.
Patrick Yachimski, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plastic biliary stent and FCSEMS in people with Bile Leak, run by Vanderbilt University Medical Center 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cholangiographic Resolution of Bile Leak at Follow-up ECRP (time frame: up to 6 weeks). 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 7 Mar 2022.