Plastic Stenting Versus Retrievable Metallic Stenting for Biliary Anastomotic Stricture After Liver Transplantation (LT)

October 29, 2019 updated by: Dr. Kenneth Siu-Ho Chok, The University of Hong Kong

Prospective Randomized Controlled Trial on Balloon Dilatation and Plastic Stenting Versus Retrievable Metallic Stenting for Biliary Anastomotic Stricture After Liver Transplantation

Liver transplantation is the best treatment option for patients with end-stage liver disease and early unresectable hepatocellular carcinoma. Unfortunately, biliary complication after liver transplantation is still the Achilles' heel, especially in living donor liver transplantation. Early treatment with endoscopy can achieve satisfactory outcomes. Most of the time, biliary anastomotic stricture can be treated by endoscopic retrograde cholangiopancreatography with balloon dilatation with or without plastic stent insertion. Although endoscopic treatment has been reported to have a successful rate of over 70%, multiple sessions of endoscopic treatment, typically 4 to 5 sessions, are frequently required before adequate stricture dilatation is achieved. This is likely secondary to suboptimal post-dilatation splintage. The most common and popular form of splintage is plastic stent insertion. Unfortunately, plastic biliary stent has a small calibre, and therefore even with multiple stents the configuration of buttressing would not provide a circumferential, evenly distributed buttressing effect at the dilated stricture site. Moreover, given the small calibre of the plastic stent, there is higher resistance on the inner surface of the stent, leading to a higher chance of stent blockage. Many studies have suggested that self-expandable metallic stent (SEMS) is superior to plastic stent in terms of patency rate. However, SEMS is generally reserved for malignant stricture due to its permanent nature, as the traditional SEMS is not removable. Recently, retrievable SEMS (r-SEMS) has been developed, and its indications have been extended to include benign disease conditions. It has been reported that a series of 29 patients with biliary anastomotic stricture treated by r-SEMS, and they concluded that r-SEMS was safe and efficacious. Results of the preliminary study on 5 patients at our centre were favourable; all of the patients had no stricture after retrievable metallic stenting for at least 3 months and no complication was encountered.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Biliary anastomotic stricture (BAS) is one of the most common complications after liver transplantation (LT). It happens more often after living donor liver transplantation (LDLT) than deceased donor liver transplantation (DDLT). The reported incidence was 20% in LDLT and 12% in DDLT. Although BAS seldom affects graft survival, it is associated with significant morbidity and affects quality of life. Clinical manifestation of BAS can be highly variable, ranging from low-grade cholangitis with slightly deranged liver function to life-threatening septic shock to graft and multi-organ failure. Up to 30% of the cases of BAS require surgical intervention at some point. Revision hepaticojejunostomy - a major undertaking judging from the magnitude of the operation - is sometimes required as a remedial procedure. Most of the time BAS can be treated by endoscopic retrograde cholangiopancreatography (ERCP) with balloon dilatation with or without plastic stent insertion. Although endoscopic treatment has been reported to have a successful rate of over 70%, multiple sessions of endoscopic treatment, typically 4 to 5 sessions, are frequently required before adequate stricture dilatation is achieved. This is likely secondary to suboptimal post-dilatation splintage. Since stricturoplasty features breaking up the fibrous ring at the anastomotic site and hence widening the calibre of the lumen, any new wound created by dilatation injury is susceptible to the formation of new scar. Therefore, some form of buttressing device is needed to keep the anastomotic site open. This underscores the importance of post-dilatation splintage. The most common and popular form of splintage is plastic stent insertion. Unfortunately, plastic biliary stents have a small calibre, with the largest size being Fr11.5 only. Even if multiple stents are inserted, the configuration of buttressing would not provide a circumferential, evenly distributed buttressing effect at the dilated stricture site. Moreover, given the small calibre of the plastic stent, there is higher resistance on the inner surface of the stent, leading to a higher chance of stent blockage. Frequent admissions for repeated dilatation and stent exchange (not to mention emergency admission for a cholangitic episode secondary to stent blockage) significantly disrupt the patient's normal daily activities and form a clinical and financial burden to the community. Many studies have suggested that self-expandable metallic stent (SEMS) is superior to plastic stent in terms of patency rate. However, SEMS is generally reserved for malignant stricture due to its permanent nature, as the traditional SEMS is not removable. Recently, retrievable SEMS (r-SEMS) has been developed, and its indications have been extended to include benign disease condition. It has been reported that a series of 29 BAS patients treated by r-SEMS, and they concluded that r-SEMS was safe and efficacious. Results of the preliminary study on 5 patients at our centre were favourable; all of them had no stricture for at least 4 months after r-SEMS treatment and no complication was encountered. The median number of session for success was 2, which is significantly fewer than that in the ordinary approach (median session: 4).

Up till this moment, there is no randomized controlled trial comparing the performance of r-SEMS with that of the conventional approach. In this study, the null hypothesis is that there is no difference in performance between r-SEMS and the conventional approach in endoscopic treatment of BAS.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who give informed consent

Exclusion Criteria:

  • Patients who refuse to give consent
  • Patients who have previously hepaticojejunostomy as biliary re-construction
  • Patients who have previous upper gastrointestinal surgery making endoscopic treatment not posssible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Plastic stenting
Patients with post-liver transplantation and suffer from biliary anastomotic stricture would be given balloon dilatation and plastic stenting for treatment.
Device: Plastic stenting
Use of plastic stents
Active Comparator: Retrievable metallic stenting
Patients with post-liver transplantation and suffer from biliary anastomotic stricture would be given retrievable metallic stenting for treatment.
Device: Retrievable metallic stenting
Use of retrievable metallic stents for the treatment of biliary anastomotic stricture after liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of endoscopic sessions to achieve resolution of stricture
Time Frame: Two months
To compare the total number of treatments to successfully resolve the problem of biliary stricture in each arm
Two months
Percentage of successful treatment
Time Frame: Two months
To compare the total rate of successful treatment in each arm
Two months
Pain score after treatment
Time Frame: Two months
To compare the differential pain score experienced by patients in each arm as rated by facial pain score scale (Ranging from 0-10) Maximum pain score = 10; No pain = 0)
Two months
Patient's quality of life
Time Frame: Two months
To compare the quality of life as experienced by patients who have undergone stenting treatment(s) in each arm using SF36 questionnaire with maximum score=100 as the best outcome and minimum score=0 as the worst
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 2 months
To compare the rate of complications such as post-ERCP pancreatitis, bleeding and perforation between patients who have received plastic or metallic stents
2 months
Hospital stay
Time Frame: Two months
To compare the duration of hospital stay between patients who have received plastic or metallic stents
Two months
BAS recurrence
Time Frame: Two months
To compare the rate of BAS recurrence between patients who have received plastic or metallic stents
Two months
Readmission rate
Time Frame: Two months
To compare the rate of readmission rate between patients who have received plastic or metallic stents
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Kenneth Chok, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 19-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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