Liver Transplant; Complications
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBard 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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * will be undergoing liver transplantation * able to give informed consent
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biliary Complications | 6 months after transplantation | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| Reconstruction Without Stent Placement Subjects will undergo biliary reconstruction without stent placement. | 57 |
| Total | 115 |
Baseline characteristics
| Characteristic | Reconstruction With Stent Placement | Reconstruction Without Stent Placement | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 24 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 33 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 55 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 51 Participants | 54 Participants | 105 Participants |
| Region of Enrollment United States | 58 participants | 57 participants | 115 participants |
| Sex: Female, Male Female | 23 Participants | 15 Participants | 38 Participants |
| Sex: Female, Male Male | 35 Participants | 42 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 58 | 7 / 57 |
| other Total, other adverse events | 0 / 58 | 0 / 57 |
| serious Total, serious adverse events | 19 / 58 | 14 / 57 |
Outcome results
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.
Time frame: 6 months after transplantation
Population: There was lack of significant difference between intervention groups so it was decided to not proceed with original 2 year analysis plan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reconstruction With Stent Placement | Number of Participants With Biliary Complications | 19 participants |
| Reconstruction Without Stent Placement | Number of Participants With Biliary Complications | 12 participants |
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.
Time frame: 12 months after transplantation
Population: There was lack of significant difference between intervention groups so it was decided to not proceed with original 2 year analysis plan.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reconstruction With Stent Placement | Number of Participants With Biliary Complications | 19 Participants |
| Reconstruction Without Stent Placement | Number of Participants With Biliary Complications | 14 Participants |