Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks

Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks Following Orthotopic Liver Transplant (OLT): a Randomized Controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03333382

Enrollment

Registered

2017-11-06

Start date

2018-01-30

Completion date

2020-09-21

Last updated

2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Leak

Brief 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. 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.

Interventions

DEVICEPlastic biliary stent

Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.

DEVICEFCSEMS

FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* patients who have undergone OLT with hepaticojejunostomy * patients who have undergone percutaneous transhepatic cholangiogram with percutaneous biliary intervention following OLT and prior to ERCP

Design outcomes

Primary

Measure	Time frame	Description
Cholangiographic Resolution of Bile Leak at Follow-up ECRP	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.

Secondary

Measure	Time frame	Description
Need for Repeat Endoscopic Intervention (ERCP) Within Initial 8 Weeks Following Placement of a Plastic Stent or FCSEMS	8 weeks	Analysis for need of repeat endoscopic intervention (ERCP) within initial 8 weeks following placement of a plastic stent or FCSEMS will be completed.
Need for Percutaneous Drainage of Biloma or Intraabdominal Fluid Collection Following Placement of a Plastic Stent or FCSEMS	90 days	Participants will be analyzed regarding need for percutaneous drainage of biloma or intraabdominal fluid collection following placement of a plastic stent or FCSEMS.
Need for Surgical Biliary Reconstruction for Refractory Anastomotic Bile Leak	90 days	Participants will be analyzed for need of surgical biliary reconstruction for refractory anastomotic bile leak
Need for Repeat OLT	90 days	Analysis for of need for orthotopic liver transplant (OLT) will be completed.
Death at 90 Days	90 days	Participants will be followed and chart review will be completed to see if death occurred within 90 days.
Rate of Stent Migration Following Placement of a Plastic Stent vs FCSEMS	90 days	Analysis will be performed to determine the rate of stent migration following placement of a plastic stent vs FCSEMS.
Rate of Anastomotic Biliary Stricture at Follow-up ERCP 8 Weeks Following Placement of a Plastic Stent or FCSEMS	8 weeks	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.
Need for Repeat ERCP for Management of Anastomotic Biliary Stricture Within 90 Days Following Leak Resolution	90 days	Participants will be analyzed for need of repeat ERCP for management of anastomotic biliary stricture within 90 days following leak resolution.
Rate of Post-ERCP Pancreatitis (PEP) Following Placement of a Plastic Stent vs FCSEMS	90 days	Analysis will be performed to determine rate of post-ERCP pancreatitis (PEP) following placement of a plastic stent vs FCSEMS.

Countries

United States

Participant flow

Recruitment details

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).

Pre-assignment details

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

Participants by arm

Arm	Count
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.	1
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.	0
Total	1

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Total	Plastic Biliary Stent
Age, Categorical <=18 years	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	1 Participants	1 Participants
Age, Continuous	62 Years STANDARD_DEVIATION 0	62 Years STANDARD_DEVIATION 0
Race and Ethnicity Not Collected	0 Participants	—
Region of Enrollment United States	1 participants	1 participants
Sex: Female, Male Female	0 Participants	0 Participants
Sex: Female, Male Male	1 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 1	0 / 0
other Total, other adverse events	0 / 1	0 / 0
serious Total, serious adverse events	0 / 1	0 / 0

Outcome results

Primary

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.

Time frame: up to 6 weeks