Transplant Library

Multiple plastic stents versus covered metal stent for treatment of anastomotic biliary strictures after liver transplantation: a prospective, randomized, multicenter trial

Gastrointest Endosc. 2017 Dec;86(6):1038-1045 doi: 10.1016/j.gie.2017.03.009.

Elsevier Science

Abstract

BACKGROUND AND AIMS:

Treatment of anastomotic biliary strictures (ABSs) after orthotopic liver transplantation by endoscopic insertion of multiple plastic stents (MPSs) is well established. The use of covered self-expandable metal stents (cSEMSs) for this indication is less investigated.

METHODS:

In an open-label, multicenter, randomized trial, patients with confirmed ABSs were randomly assigned 1:1 to receive either an MPS or a cSEMS. The primary endpoint was the number of endoscopic interventions until ABS resolution. Secondary endpoints were frequency of adverse events, treatment success rates, and time to treatment success and recurrence of ABS during follow-up of at least 1 year.

RESULTS:

Fifty-eight patients were included between 2012 and 2015, and 48 patients completed follow-up. Patients receiving MPS (n = 24) underwent a median of 4 (range, 3-12) endoscopic retrograde cholangiography examinations, whereas those in the cSEMS group (n = 24) underwent a median of 2 (range, 2-12) sessions until ABS resolution (P < .001). A median of 8 (range, 2-32) stents was used until ABS resolution within the MPS group and 1 (range, 1-24) in the cSEMS group (P < .0001). cSEMS migration occurred in 8 (33.3%) patients. Treatment duration did not differ significantly. Initial treatment success rates were high with 23 (95.8%) in the MPS group and 24 (100%) for cSEMSs (P = 1). Five (20.8%) patients in both groups showed stricture recurrence after a median follow-up of 500 days (range, 48-1317 days).

CONCLUSIONS:

cSEMSs for treatment of ABSs needed less endoscopic interventions to achieve similar efficacy as MPS and might become a new treatment standard. However, the optimal duration of cSEMS therapy and cost-efficacy have to be evaluated. (Clinical trial registration number: NCT01393067.).

CET Conclusion

Reviewer:	Sir Peter Morris, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Conclusion:	Anastomotic biliary strictures are a major cause of morbidity after orthotropic liver transplantation and occur in around 15% of recipients. These are managed non-surgically and in general involve the insertion endoscopically or percutaneously of plastic stents usually on several occasions. In general four to five interventions are required until the stricture is dilated sufficiently. In this study from four centres (Helsinki, Essen, Frankfurt and Milan), 58 patients with anastomotic biliary structure were randomised to be treated either with multiple plastic stents or covered self-expandable metal stents and 48 completed follow up. Fewer endoscopic interventions were required with metal stents and fewer metal stents than plastic stents were required till resolution of the stricture. However, migration of the metal stents occurred in 33% of patients. The authors do point out that there are several coated metal stents available and in this trial use was not limited to one single pilot stent and so it is possible that some may be superior to others. As improvement in the coated metal stents occurs this should decrease the migration rates of these stents but the optimal duration of this type of therapy, and the cost efficacy of the metal stents versus the multiple plastic stents, require further investigation.

Reviewer:

Sir Peter Morris, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.

Conclusion:

Anastomotic biliary strictures are a major cause of morbidity after orthotropic liver transplantation and occur in around 15% of recipients. These are managed non-surgically and in general involve the insertion endoscopically or percutaneously of plastic stents usually on several occasions. In general four to five interventions are required until the stricture is dilated sufficiently. In this study from four centres (Helsinki, Essen, Frankfurt and Milan), 58 patients with anastomotic biliary structure were randomised to be treated either with multiple plastic stents or covered self-expandable metal stents and 48 completed follow up. Fewer endoscopic interventions were required with metal stents and fewer metal stents than plastic stents were required till resolution of the stricture. However, migration of the metal stents occurred in 33% of patients. The authors do point out that there are several coated metal stents available and in this trial use was not limited to one single pilot stent and so it is possible that some may be superior to others. As improvement in the coated metal stents occurs this should decrease the migration rates of these stents but the optimal duration of this type of therapy, and the cost efficacy of the metal stents versus the multiple plastic stents, require further investigation.

Methodological quality

Jadad score	3
Allocation concealment	NO
Data analysis	MODIFIED INTENTION TO TREAT

Study Details

Aims:	To investigate the use of covered self-expandable metal stents (cSEMSs) compared to multiple plastic stents (MPSs) for the treatment of anastomotic biliary strictures (ABSs) after orthotopic liver transplantation (OLT).
Interventions:	Participants were randomized to receive either MPSs or cSEMSs.
Participants:	58 patients who underwent deceased donor OLT for end−stage liver disease or acute liver failure with confirmed ABS.
Outcomes:	The primary outcome measured was the number of endoscopic interventions until ABS resolution. Secondary outcomes measured were frequency of adverse events, treatment success rates, time to treatment success and recurrence of ABS during follow-up.
Follow Up:	1 year

Metadata

Funding:	No funding was received for this study
Publication type:	Multicenter Study, Randomized Controlled Trial, Randomised Controlled Trial
Trial registration:	ClinicalTrials.gov - NCT01393067
Organ:	Liver
Language:	English
MeSH terms:	Adult; Aged; Anastomosis, Surgical; Bile Ducts, Extrahepatic; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Constriction, Pathologic; Female; Humans; Liver Transplantation; Male; Middle Aged; Plastics; Prospective Studies; Prosthesis Failure; Retreatment; Self Expandable Metallic Stents; Treatment Outcome; 0 (Plastics)