Christophe Bureau1, Dominique Thabut2, Frédéric Oberti3, Sébastien Dharancy4, Nicolas Carbonell5, Antoine Bouvier3, Philippe Mathurin4, Philippe Otal6, Pauline Cabarrou7, Jean Marie Péron8, Jean Pierre Vinel8. 1. Service d'hépato-gastroentérologie, Hôpital Purpan Centre Hospitalier Universitaire Toulouse, Toulouse Cedex, France; Université Paul Sabatier Toulouse III, Toulouse Cedex, France. Electronic address: Bureau.c@chu-toulouse.fr. 2. Hôpital Pitie-Salpetriere Paris, Île-de-France, France. 3. Centre Hospitalier Universitaire d'Angers, Angers, Pays de la Loire, France. 4. Hôpital Huriez, Service des maladies de l'appareil digestif, Lille, France. 5. Hôpital Saint-Antoine, Paris, Île-de-France, France. 6. Université Paul Sabatier Toulouse III, Toulouse Cedex, France; Service de Radiologie, Hôpital Rangueil, Centre Hospitalier Universitaire Toulouse, Toulouse Cedex, France. 7. Service d'hépato-gastroentérologie, Hôpital Purpan Centre Hospitalier Universitaire Toulouse, Toulouse Cedex, France. 8. Service d'hépato-gastroentérologie, Hôpital Purpan Centre Hospitalier Universitaire Toulouse, Toulouse Cedex, France; Université Paul Sabatier Toulouse III, Toulouse Cedex, France.
Abstract
BACKGROUND & AIMS: There is controversy over the ability of transjugular intrahepatic portosystemic shunts (TIPS) to increase survival times of patients with cirrhosis and refractory ascites. The high rate of shunt dysfunction with the use of uncovered stents counteracts the benefits of TIPS. We performed a randomized controlled trial to determine the effects of TIPS with stents covered with polytetrafluoroethylene in these patients. METHODS: We performed a prospective study of 62 patients with cirrhosis and at least 2 large-volume paracenteses within a period of at least 3 weeks; the study was performed at 4 tertiary care centers in France from August 2005 through December 2012. Patients were randomly assigned to groups that received covered TIPS (n = 29) or large-volume paracenteses and albumin as necessary (LVP+A, n = 33). All patients maintained a low-salt diet and were examined at 1 month after the procedure then every 3 months until 1 year. At each visit, liver disease-related complications, treatment modifications, and clinical and biochemical variables needed to calculate Child-Pugh and Model for End-Stage Liver Disease scores were recorded. Doppler ultrasonography was performed at the start of the study and then at 6 and 12 months after the procedure. The primary study end point was survival without a liver transplant for 1 year after the procedure. RESULTS: A higher proportion of patients in the TIPS group (93%) met the primary end point than in the LVP+A group (52%) (P = .003). The total number of paracenteses was 32 in the TIPS group vs 320 in the LVP+A group. Higher proportions of patients in the LVP+A group had portal hypertension-related bleeding (18% vs 0%; P = .01) or hernia-related complications (18% vs 0%; P = .01) than in the TIPS group. Patients in LVP+A group had twice as many days of hospitalization (35 days) as the TIPS group (17 days) (P = .04). The 1-year probability of remaining free of encephalopathy was 65% for each group. CONCLUSIONS: In a randomized trial, we found covered stents for TIPS to increase the proportion of patients with cirrhosis and recurrent ascites who survive transplantation-free for 1 year, compared with patients given repeated LVP+A. These findings support TIPS as the first-line intervention in such patients. ClinicalTrials.gov ID: NCT00222014.
RCT Entities:
BACKGROUND & AIMS: There is controversy over the ability of transjugular intrahepatic portosystemic shunts (TIPS) to increase survival times of patients with cirrhosis and refractory ascites. The high rate of shunt dysfunction with the use of uncovered stents counteracts the benefits of TIPS. We performed a randomized controlled trial to determine the effects of TIPS with stents covered with polytetrafluoroethylene in these patients. METHODS: We performed a prospective study of 62 patients with cirrhosis and at least 2 large-volume paracenteses within a period of at least 3 weeks; the study was performed at 4 tertiary care centers in France from August 2005 through December 2012. Patients were randomly assigned to groups that received covered TIPS (n = 29) or large-volume paracenteses and albumin as necessary (LVP+A, n = 33). All patients maintained a low-salt diet and were examined at 1 month after the procedure then every 3 months until 1 year. At each visit, liver disease-related complications, treatment modifications, and clinical and biochemical variables needed to calculate Child-Pugh and Model for End-Stage Liver Disease scores were recorded. Doppler ultrasonography was performed at the start of the study and then at 6 and 12 months after the procedure. The primary study end point was survival without a liver transplant for 1 year after the procedure. RESULTS: A higher proportion of patients in the TIPS group (93%) met the primary end point than in the LVP+A group (52%) (P = .003). The total number of paracenteses was 32 in the TIPS group vs 320 in the LVP+A group. Higher proportions of patients in the LVP+A group had portal hypertension-related bleeding (18% vs 0%; P = .01) or hernia-related complications (18% vs 0%; P = .01) than in the TIPS group. Patients in LVP+A group had twice as many days of hospitalization (35 days) as the TIPS group (17 days) (P = .04). The 1-year probability of remaining free of encephalopathy was 65% for each group. CONCLUSIONS: In a randomized trial, we found covered stents for TIPS to increase the proportion of patients with cirrhosis and recurrent ascites who survive transplantation-free for 1 year, compared with patients given repeated LVP+A. These findings support TIPS as the first-line intervention in such patients. ClinicalTrials.gov ID: NCT00222014.
Authors: Gideon M Hirschfield; Jessica K Dyson; Graeme J M Alexander; Michael H Chapman; Jane Collier; Stefan Hübscher; Imran Patanwala; Stephen P Pereira; Collette Thain; Douglas Thorburn; Dina Tiniakos; Martine Walmsley; George Webster; David E J Jones Journal: Gut Date: 2018-03-28 Impact factor: 23.059