I Lisanne Holster1, Eric T T L Tjwa1, Adriaan Moelker2, Alexandra Wils2, Bettina E Hansen1, J Reinoud Vermeijden3, Pieter Scholten4, Bart van Hoek5, Jan J Nicolai6, Ernst J Kuipers1,7, Peter M T Pattynama2, Henk R van Buuren1. 1. Departments of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 2. Departments of Radiology, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 3. Department of Gastroenterology and Hepatology, and Meander MC, Amersfoort, The Netherlands. 4. Sint Lucas Andreas Hospital, Amsterdam, The Netherlands. 5. LUMC, Leiden, the Netherlands. 6. HagaHospital, Den Haag, The Netherlands. 7. Departments of Internal Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Abstract
UNLABELLED: Gastroesophageal variceal bleeding in patients with cirrhosis is associated with significant morbidity and mortality, as well as a high rebleeding risk. Limited data are available on the role of transjugular intrahepatic portosystemic shunt (TIPS) with covered stents in patients receiving standard endoscopic, vasoactive, and antibiotic treatment. In this multicenter randomized trial, long-term endoscopic variceal ligation (EVL) or glue injection + β-blocker treatment was compared with TIPS placement in 72 patients with a first or second episode of gastric and/or esophageal variceal bleeding, after hemodynamic stabilization upon endoscopic, vasoactive, and antibiotic treatment. Randomization was stratified according to Child-Pugh score. Kaplan-Meier (event-free) survival estimates were used for the endpoints rebleeding, death, treatment failure, and hepatic encephalopathy. During a median follow-up of 23 months, 10 (29%) of 35 patients in the endoscopy + β-blocker group, as compared to 0 of 37 (0%) patients in the TIPS group, developed variceal rebleeding (P = 0.001). Mortality (TIPS 32% vs. endoscopy 26%; P = 0.418) and treatment failure (TIPS 38% vs. endoscopy 34%; P = 0.685) did not differ between groups. Early hepatic encephalopathy (within 1 year) was significantly more frequent in the TIPS group (35% vs. 14%; P = 0.035), but during long-term follow-up this difference diminished (38% vs. 23%; P = 0.121). CONCLUSIONS: In unselected patients with cirrhosis, who underwent successful endoscopic hemostasis for variceal bleeding, covered TIPS was superior to EVL + β-blocker for reduction of variceal rebleeding, but did not improve survival. TIPS was associated with higher rates of early hepatic encephalopathy.
RCT Entities:
UNLABELLED: Gastroesophageal variceal bleeding in patients with cirrhosis is associated with significant morbidity and mortality, as well as a high rebleeding risk. Limited data are available on the role of transjugular intrahepatic portosystemic shunt (TIPS) with covered stents in patients receiving standard endoscopic, vasoactive, and antibiotic treatment. In this multicenter randomized trial, long-term endoscopic variceal ligation (EVL) or glue injection + β-blocker treatment was compared with TIPS placement in 72 patients with a first or second episode of gastric and/or esophageal variceal bleeding, after hemodynamic stabilization upon endoscopic, vasoactive, and antibiotic treatment. Randomization was stratified according to Child-Pugh score. Kaplan-Meier (event-free) survival estimates were used for the endpoints rebleeding, death, treatment failure, and hepatic encephalopathy. During a median follow-up of 23 months, 10 (29%) of 35 patients in the endoscopy + β-blocker group, as compared to 0 of 37 (0%) patients in the TIPS group, developed variceal rebleeding (P = 0.001). Mortality (TIPS 32% vs. endoscopy 26%; P = 0.418) and treatment failure (TIPS 38% vs. endoscopy 34%; P = 0.685) did not differ between groups. Early hepatic encephalopathy (within 1 year) was significantly more frequent in the TIPS group (35% vs. 14%; P = 0.035), but during long-term follow-up this difference diminished (38% vs. 23%; P = 0.121). CONCLUSIONS: In unselected patients with cirrhosis, who underwent successful endoscopic hemostasis for variceal bleeding, covered TIPS was superior to EVL + β-blocker for reduction of variceal rebleeding, but did not improve survival. TIPS was associated with higher rates of early hepatic encephalopathy.
Authors: Shivaram P Singh; Manav Wadhawan; Subrat K Acharya; Sawan Bopanna; Kaushal Madan; Manoj K Sahoo; Naresh Bhat; Sri P Misra; Ajay Duseja; Amar Mukund; Anil C Anand; Ashish Goel; Bonthala S Satyaprakash; Joy Varghese; Manas K Panigrahi; Manu Tandan; Mihir K Mohapatra; Pankaj Puri; Pravin M Rathi; Rajkumar P Wadhwa; Sunil Taneja; Varghese Thomas; Vikram Bhatia Journal: Indian J Gastroenterol Date: 2021-12-10