Trial Outcomes & Findings for Study to Compare the Incidence of Biliary Complications After Liver Transplantation (NCT NCT03165916)

NCT ID: NCT03165916

Last Updated: 2021-12-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 146 participants
• Primary outcome timeframe: 6 months after transplantation
• Results posted on: 2021-12-08

Participant Flow

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.

Participant milestones

Measure	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.	Reconstruction Without Stent Placement Subjects will undergo biliary reconstruction without stent placement.
Overall Study STARTED	58	57
Overall Study Reconstruction Interventions	59	57
Overall Study COMPLETED	58	57
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Compare the Incidence of Biliary Complications After Liver Transplantation

Baseline characteristics by cohort

Measure	Reconstruction With Stent Placement n=58 Participants 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.	Reconstruction Without Stent Placement n=57 Participants Subjects will undergo biliary reconstruction without stent placement.	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	15 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	42 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants	54 Participants n=7 Participants	105 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	57 participants n=7 Participants	115 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Reconstruction With Stent Placement n=58 Participants 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.	Reconstruction Without Stent Placement n=57 Participants Subjects will undergo biliary reconstruction without stent placement.
Number of Participants With Biliary Complications	19 participants	12 participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Reconstruction With Stent Placement n=58 Participants 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.	Reconstruction Without Stent Placement n=57 Participants Subjects will undergo biliary reconstruction without stent placement.
Number of Participants With Biliary Complications	19 Participants	14 Participants

Adverse Events

Reconstruction With Stent Placement

Serious events: 19 serious events

Other events: 0 other events

Deaths: 2 deaths

Reconstruction Without Stent Placement

Serious events: 14 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Measure	Reconstruction With Stent Placement n=58 participants at risk 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.	Reconstruction Without Stent Placement n=57 participants at risk Subjects will undergo biliary reconstruction without stent placement.
Hepatobiliary disorders Biliary Complications	32.8% 19/58 • Number of events 38 • 12 months Adverse event monitoring/assessing was limited to biliary complications related to procedure.	24.6% 14/57 • Number of events 28 • 12 months Adverse event monitoring/assessing was limited to biliary complications related to procedure.

Other adverse events

Adverse event data not reported

Additional Information

Tina Higginbotham

GI Clinical Research Enterprise

Phone: 615-322-4643

Email: tina.higginbotham@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place