Not provided
Not provided
Not provided
Not provided
Not provided
Post transplant leaks are now less frequent at VUMC and we struggled to enroll.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plastic Biliary Stent | Active Comparator | 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). |
|
| FCSEMS | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plastic biliary stent | Device | Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Repeat Endoscopic Intervention (ERCP) Within Initial 8 Weeks Following Placement of a Plastic Stent or FCSEMS | Analysis for need of repeat endoscopic intervention (ERCP) within initial 8 weeks following placement of a plastic stent or FCSEMS will be completed. | 8 weeks |
| Need for Percutaneous Drainage of Biloma or Intraabdominal Fluid Collection Following Placement of a Plastic Stent or FCSEMS |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick Yachimski, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Only 1 participant was randomized. However, they were lost to follow-up. No participants completed the study.
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only 1 participant was randomized in the study. This participant was randomized to the Plastic Biliary Stent arm. No participants were randomized to the FCSEMS arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | up to 6 weeks |
|
6 months
Definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
One participant screen failed before being randomized to either arm of the study. A second participant was enrolled in August 21, 2018 and was lost to follow-up. No other participants were enrolled. The study remained open in anticipation of enrolling more participants. Post transplant leaks have become less frequent at VUMC, and we struggled to enroll. In September 2020, the decision was made to close the study due to low enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharee Burkeen, Research Program Manager | Vanderbilt University Medical Center | (615) 875-7515 | sharee.k.burkeen@vumc.org |
Not provided
| 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 | Oct 11, 2017 | Nov 29, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FCSEMS | Device | FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak. |
|
Participants will be analyzed regarding need for percutaneous drainage of biloma or intraabdominal fluid collection following placement of a plastic stent or FCSEMS. |
| 90 days |
| Need for Surgical Biliary Reconstruction for Refractory Anastomotic Bile Leak | Participants will be analyzed for need of surgical biliary reconstruction for refractory anastomotic bile leak | 90 days |
| Need for Repeat OLT | Analysis for of need for orthotopic liver transplant (OLT) will be completed. | 90 days |
| Death at 90 Days | Participants will be followed and chart review will be completed to see if death occurred within 90 days. | 90 days |
| Rate of Post-ERCP Pancreatitis (PEP) Following Placement of a Plastic Stent vs FCSEMS | Analysis will be performed to determine rate of post-ERCP pancreatitis (PEP) following placement of a plastic stent vs FCSEMS. | 90 days |
| Rate of Stent Migration Following Placement of a Plastic Stent vs FCSEMS | Analysis will be performed to determine the rate of stent migration following placement of a plastic stent vs FCSEMS. | 90 days |
| Rate of Anastomotic Biliary Stricture at Follow-up ERCP 8 Weeks Following Placement of a Plastic Stent or FCSEMS | 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. | 8 weeks |
| Need for Repeat ERCP for Management of Anastomotic Biliary Stricture Within 90 Days Following Leak Resolution | Participants will be analyzed for need of repeat ERCP for management of anastomotic biliary stricture within 90 days following leak resolution. | 90 days |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
| Secondary | Need for Repeat Endoscopic Intervention (ERCP) Within Initial 8 Weeks Following Placement of a Plastic Stent or FCSEMS | Analysis for need of repeat endoscopic intervention (ERCP) within initial 8 weeks following placement of a plastic stent or FCSEMS will be completed. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 8 weeks |
|
|
| Secondary | Need for Percutaneous Drainage of Biloma or Intraabdominal Fluid Collection Following Placement of a Plastic Stent or FCSEMS | Participants will be analyzed regarding need for percutaneous drainage of biloma or intraabdominal fluid collection following placement of a plastic stent or FCSEMS. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 90 days |
|
|
| Secondary | Need for Surgical Biliary Reconstruction for Refractory Anastomotic Bile Leak | Participants will be analyzed for need of surgical biliary reconstruction for refractory anastomotic bile leak | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 90 days |
|
|
| Secondary | Need for Repeat OLT | Analysis for of need for orthotopic liver transplant (OLT) will be completed. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 90 days |
|
|
| Secondary | Death at 90 Days | Participants will be followed and chart review will be completed to see if death occurred within 90 days. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 90 days |
|
|
| Secondary | Rate of Post-ERCP Pancreatitis (PEP) Following Placement of a Plastic Stent vs FCSEMS | Analysis will be performed to determine rate of post-ERCP pancreatitis (PEP) following placement of a plastic stent vs FCSEMS. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 90 days |
|
|
| Secondary | Rate of Stent Migration Following Placement of a Plastic Stent vs FCSEMS | Analysis will be performed to determine the rate of stent migration following placement of a plastic stent vs FCSEMS. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 90 days |
|
|
| Secondary | Rate of Anastomotic Biliary Stricture at Follow-up ERCP 8 Weeks Following Placement of a Plastic Stent or FCSEMS | 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. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 8 weeks |
|
|
| Secondary | Need for Repeat ERCP for Management of Anastomotic Biliary Stricture Within 90 Days Following Leak Resolution | Participants will be analyzed for need of repeat ERCP for management of anastomotic biliary stricture within 90 days following leak resolution. | Participant enrolled to Plastic Biliary Stent arm was lost to follow-up. No participants were randomized to the FCSEMS arm. | Posted | 90 days |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided