Elsevier

The Lancet

Volume 349, Issue 9058, 12 April 1997, Pages 1043-1049
The Lancet

Articles
Randomised trial of transjugular-intrahepatic-portosystemic shunt versus endoscopy plus propranolol for prevention of variceal rebleeding

https://doi.org/10.1016/S0140-6736(96)08189-5Get rights and content

Summary

Background

The transjugular-intrahepatic-portosystemic shunt is a new interventional treatment for portal hypertension. The aim of our study was to compare the transjugular shunt with endoscopic treatment for the prophylaxis of recurrent variceal bleeding.

Methods

Between March, 1993, and March, 1996, 126 patients with variceal bleeding were randomly assigned either transjugular shunt (n=61) or endoscopic treatment (n=65). Patients were followed up for a median of 14 (IQR 8–25) months and 13 (8–25) months, respectively. In 31 (51%) of the shunted patients, simultaneous transjugular-variceal embolisation was done at the time of shunt placement. Endoscopic treatment consisted of sclerotherapy and/or banding ligation and was combined with propranolol medication.

Findings

Technical success was achieved in all patients assigned to the shunt group. During follow-up, the cumulative 1-year variceal rebleeding rates in the shunted and endoscopically treated patients were 15% and 41% and the 2-year rates were 21% and 52% (p=0·001), respectively. In nine (12%) patients from the endoscopic group treatment failed and the patients received the transjugular-shunt treatment. A total of 19 bleeding episodes from any source occurred in 15 patients in the shunt group compared with 100 episodes in 33 patients in the endoscopic group. There was no difference in survival with estimated 1-year survival rates for shunted and endoscopically treated patients of 90% and 89%, and 2-year survival rates of 79% and 82%, respectively. The incidence of clinically significant hepatic encephalopathy after 1 year was higher in the shunt group (36% vs 18%, p=0·011).

Interpretation

These results suggest, that the transjugular shunt is more effective than endoscopic treatment in prevention of variceal rebleeding but has a considerable risk of hepatic encephalopathy. Survival is similar in the two groups.

Introduction

The transjugular-intrahepatic-portosystemic shunt is an interventional procedure consisting of an anastomosis between a hepatic vein and an intrahepatic branch of the portal vein. This type of shunt was introduced into clinical practice in 1988 and its use has become widely accepted despite the lack of comparative studies with conventional treatments.1, 2 The transjugular shunt functions in a similar way to surgical shunts. There are, however, many differences between results when surgical shunts are compared with transjugular shunts. First, the procedural and hospital mortality of the transjugular shunt is about 1% compared with 3% to 15% for surgical shunts.3, 4 Second, the invasiveness of the transjugular shunt is low and justifies its use in older patients (>70 years), in emergency cases, and in patients of Child-Pugh class C who are excluded from most surgical-shunt studies.3, 4, 5, 6, 7 Third, the transjugular shunt provides the option of calibration of the shunt—ie, enlargement or reduction–at any time after its establishment. However, the transjugular shunt has a major disadvantage in that it has a high rate (40% to 50%) of dysfunction that usually needs correction.3, 4, 8

This randomised study was designed to compare the transjugular shunt with endoscopic treatment plus propranolol in the prevention of recurrent variceal bleeding. The number of bleedings from any source, survival, procedure-related complications, hepatic encephalopathy, Child-Pugh class, and liver function, as well as duration of hospital stay were also assessed. The addition of propranolol and the optional use of both polidocanol injection and banding ligation were allowed to compare the transjugular shunt with the most effective non-shunt strategy.

Section snippets

Methods

Between March, 1993, and March, 1996, 126 patients (table 1) with variceal bleeding were randomly assigned either transjugular shunt or endoscopic treatment. None of the patients' clinical characteristics were significantly different between the two groups including the haemodynamic findings, portal vein flow-velocity, and congestion index9 obtained by duplex-sonography.

The study protocol was approved by the local ethics committee. All patients were informed about the procedure in detail and

Results

Of the 190 eligible patients 64 could not be included in the study (figure 1). The number of patients who refused to take part was comparable to the number in each study group with respect to age, sex, Child-Pugh class, bleeding site, and number of previous bleeds and scleropathies. The median observation time of the shunted patients was 14 (IQR 8–23) months and of the endoscopically treated patients 13 (8–25) months. One patient in the shunt group and three in the endoscopic group were lost to

Discussion

Our study compares the transjugular-intrahepatic-portosystemic shunt with endoscopic treatment plus propranolol with the optional use of transjugular variceal embolisation and banding ligation, respectively. These additional measures were allowed to optimise the respective baseline treatments. So far, the combination of a transjugular shunt and variceal embolisation has not been studied. The transjugular embolisation before the stent implanation is quick and is, in our experience with more than

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