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A randomized prospective study will be conducted of patients at Vanderbilt University Medical Center who undergo liver transplantation from March 2014 until approximately 120 patients are randomized. Patients will be randomized to undergo biliary reconstruction with and without stent placement.
The risk of biliary complications can be related to the type of liver transplant performed and the technique used for reconstruction of the bile duct. One of the main techniques of performing biliary reconstruction is a choledocholedochostomy which can be performed over an anastomotic stent. Although placement of biliary stents is routine practice in many liver transplant centers around the country, there is no clear evidence to support their use. As of now both the placement and non-placement of a stent are essentially "standard of care". In the investigators' center, many of the transplant surgeons now perform the biliary anastomosis over a pediatric feeding tube which is used as a stent. The practice of using stents in biliary anastomosis is not uniform and there are no established guidelines to support their indiscriminate application. The investigators have designed a prospective randomized trial to evaluate the effect of stent placement on biliary complications and its effect on morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reconstruction with stent placement | Experimental | Subjects will undergo biliary reconstruction with stent placement at the anastomosis site. |
|
| Reconstruction without stent placement | No Intervention | Subjects will undergo biliary reconstruction without stent placement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bard 5 Fr diameter feeding tube | Device | A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biliary Complications | Biliary complications include biliary strictures, biliary leaks, cholangitis, and stones. The investigators will compare the number of complications between the group that receives the stent and the group that does not. | 6 months after transplantation |
| Number of Participants With Biliary Complications | Biliary complications include biliary strictures, biliary leaks, cholangitis, and stones. The investigators will compare the number of complications between the group that receives the stent and the group that does not. | 12 months after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Scanga, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Medical Center Liver Transplant Clinic | Nashville | Tennessee | 37232 | United States |
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146 pts enrolled in study. 1 pt w/drew consent prior to randomization. 30 pts were inappropriate candidates & weren't randomized. 115 pts were randomized. 1 pt's clinical course required a second procedure & they were randomized twice. Initially the pt randomized to not receive a stent & later to receive a stent, there were 116 interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reconstruction With Stent Placement | Subjects will undergo biliary reconstruction with stent placement at the anastomosis site. Bard 5 Fr diameter feeding tube: A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own. |
| FG001 | Reconstruction Without Stent Placement | Subjects will undergo biliary reconstruction without stent placement. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 116 interventions but only 115 participants. A participant's clinical course necessitated a second procedure, and as such, they were randomized twice. The pt was initially randomized to not receive a stent and then randomized to receive a stent during the second procedure. Demographics are based on the first randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Reconstruction With Stent Placement | Subjects will undergo biliary reconstruction with stent placement at the anastomosis site. Bard 5 Fr diameter feeding tube: A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Biliary Complications | Biliary complications include biliary strictures, biliary leaks, cholangitis, and stones. The investigators will compare the number of complications between the group that receives the stent and the group that does not. | There was lack of significant difference between intervention groups so it was decided to not proceed with original 2 year analysis plan. | Posted | Number | participants | 6 months after transplantation |
|
12 months
Adverse event monitoring/assessing was limited to biliary complications related to procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reconstruction With Stent Placement | Subjects will undergo biliary reconstruction with stent placement at the anastomosis site. Bard 5 Fr diameter feeding tube: A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary Complications | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Higginbotham | GI Clinical Research Enterprise | 615-322-4643 | tina.higginbotham@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2016 | May 28, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2017 | May 28, 2020 | ICF_001.pdf |
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| Reconstruction Without Stent Placement |
Subjects will undergo biliary reconstruction without stent placement. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Reconstruction Without Stent Placement |
Subjects will undergo biliary reconstruction without stent placement. |
|
|
| Primary | Number of Participants With Biliary Complications | Biliary complications include biliary strictures, biliary leaks, cholangitis, and stones. The investigators will compare the number of complications between the group that receives the stent and the group that does not. | There was lack of significant difference between intervention groups so it was decided to not proceed with original 2 year analysis plan. | Posted | Count of Participants | Participants | 12 months after transplantation |
|
|
|
| 2 |
| 58 |
| 19 |
| 58 |
| 0 |
| 58 |
| EG001 | Reconstruction Without Stent Placement | Subjects will undergo biliary reconstruction without stent placement. | 7 | 57 | 14 | 57 | 0 | 57 |
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