Sauerbruch, Tilman and Mengel, Martin and Dollinger, Matthias and Zipprich, Alexander and Roessle, Martin and Panther, Elisabeth and Wiest, Reiner and Caca, Karel and Hoffmeister, Albrecht and Lutz, Holger and Schoo, Ruediger and Lorenzen, Henning and Trebicka, Jonel and Appenrodt, Beate and Schepke, Michael and Fimmers, Rolf (2015) Prevention of Rebleeding From Esophageal Varices in Patients With Cirrhosis Receiving Small-Diameter Stents Versus Hemodynamically Controlled Medical Therapy. GASTROENTEROLOGY, 149 (3). 660-+. ISSN 0016-5085, 1528-0012
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND & AIMS: Patients with cirrhosis and variceal hemorrhage have a high risk of rebleeding. We performed a prospective randomized trial to compare the prevention of rebleeding in patients given a small-diameter covered stent vs those given hepatic venous pressure gradient (HVPG)-based medical therapy prophylaxis. METHODS: We performed an open-label study of patients with cirrhosis (92% Child class A or B, 70% alcoholic) treated at 10 medical centers in Germany. Patients were assigned randomly more than 5 days after variceal hemorrhage to groups given a small covered transjugular intrahepatic portosystemic stent-shunt (TIPS) (8 mm; n = 90), or medical reduction of portal pressure (propranolol and isosorbide-5-mononitrate; n = 95). HVPG was determined at the time patients were assigned to groups (baseline) and 2 weeks later. In the medical group, patients with an adequate reduction in HVPG (responders) remained on the drugs whereas nonresponders underwent only variceal band ligation. The study was closed 10 months after the last patient was assigned to a group. The primary end point was variceal rebleeding. Survival, safety (adverse events), and quality of life (based on the Short Form-36 health survey) were secondary outcome measures. RESULTS: A significantly smaller proportion of patients in the TIPS group had rebleeding within 2 years (7%) than in the medical group (26%) (P = .002). A slightly higher proportion of patients in the TIPS group experienced adverse events, including encephalopathy (18% vs 8% for medical treatment; P = .05). Rebleeding occurred in 6 of 23 patients (26%) receiving medical treatment before hemodynamic control was possible. Per-protocol analysis showed that rebleeding occurred in a smaller proportion of the 32 responders (18%) than in nonresponders who received variceal band ligation (31%) (P = .06). Fifteen patients from the medical group (16%) underwent TIPS placement during follow-up evaluation, mainly for refractory ascites. Survival time and quality of life did not differ between both randomized groups. CONCLUSIONS: Placement of a small-diameter, covered TIPS was straightforward and prevented variceal rebleeding in patients with Child A or B cirrhosis more effectively than drugs, which often required step-by-step therapy. However, TIPS did not increase survival time or quality of life and produced slightly more adverse events. Clinical Trial no: ISRCTN 16334693.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | VENOUS-PRESSURE GRADIENT; INTRAHEPATIC PORTOSYSTEMIC SHUNT; RANDOMIZED CONTROLLED-TRIAL; PORTAL-HYPERTENSION; PRIMARY PROPHYLAXIS; CONSENSUS WORKSHOP; BETA-BLOCKERS; PHARMACOLOGICAL THERAPY; ENDOSCOPIC THERAPY; PROGNOSTIC VALUE; Nonselective beta-Blocker; HVPG; TIPS; Advanced Liver Disease |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 13 Jun 2019 13:54 |
| Last Modified: | 13 Jun 2019 13:54 |
| URI: | https://pred.uni-regensburg.de/id/eprint/4945 |
Actions (login required)
 |
View Item |
