Trial Outcomes & Findings for Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks (NCT NCT03333382)

NCT ID: NCT03333382

Last Updated: 2022-03-07

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

up to 6 weeks

Results posted on

2022-03-07

Participant Flow

Participants were recruited from the patient population at the Vanderbilt Digestive Disease Center. 1 participant signed consent 1/30/18 and screen failed. 1 participant enrolled and randomized 8/21/18 and was lost to follow-up. No other participants enrolled. Study remained open in anticipation of enrolling more participants. Enrollment struggled because post transplant leaks have become less frequent at VUMC. In September 2020, the decision was made to close the study (low enrollment).

Only 1 participant was randomized. However, they were lost to follow-up. No participants completed the study.

Participant milestones

Participant milestones
Measure	Plastic Biliary Stent 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). Plastic biliary stent: Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.	FCSEMS 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). FCSEMS: FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Plastic Biliary Stent 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). Plastic biliary stent: Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.	FCSEMS 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). FCSEMS: FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plastic Biliary Stent n=1 Participants 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). Plastic biliary stent: Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.	FCSEMS 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). FCSEMS: FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	—	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants	—	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	—	0 Participants n=1 Participants
Age, Continuous	62 Years STANDARD_DEVIATION 0 • n=1 Participants	—	62 Years STANDARD_DEVIATION 0 • n=1 Participants
Sex: Female, Male Female	0 Participants n=1 Participants	—	0 Participants n=1 Participants
Sex: Female, Male Male	1 Participants n=1 Participants	—	1 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	—	1 participants n=1 Participants

PRIMARY outcome

Timeframe: up to 6 weeks

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

Analysis for need of repeat endoscopic intervention (ERCP) within initial 8 weeks following placement of a plastic stent or FCSEMS will be completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

Participants will be analyzed regarding need for percutaneous drainage of biloma or intraabdominal fluid collection following placement of a plastic stent or FCSEMS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

Participants will be analyzed for need of surgical biliary reconstruction for refractory anastomotic bile leak

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

Analysis for of need for orthotopic liver transplant (OLT) will be completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

Participants will be followed and chart review will be completed to see if death occurred within 90 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

Analysis will be performed to determine rate of post-ERCP pancreatitis (PEP) following placement of a plastic stent vs FCSEMS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

Analysis will be performed to determine the rate of stent migration following placement of a plastic stent vs FCSEMS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm.

Participants will be analyzed for need of repeat ERCP for management of anastomotic biliary stricture within 90 days following leak resolution.

Outcome measures

Outcome data not reported

Adverse Events

Plastic Biliary Stent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FCSEMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharee Burkeen, Research Program Manager

Vanderbilt University Medical Center

Phone: (615) 875-7515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place