Endoscopic Variceal Ligation plus Propranolol vs. Transjugular Intrahepatic Portosystemic Stent Shunt: A Long-Term Randomized Trial

Background and Study Aims: After a first variceal bleeding episode in patients with cirrhosis of the liver, treatment with transjugular intrahepatic portosystemic stent shunt (TIPS) and endoscopic variceal ligation (EVL) plus propranolol were compared, with regard to prevention of variceal rebleeding, complications, and mortality.
Patients and Methods: 85 patients were randomly allocated to receive TIPS (n = 43) or EVL (n = 42). The groups were comparable regarding age, sex, etiology of liver cirrhosis, and liver function.
Results: The mean observation times were 4.1 years in the TIPS group and 3.6 years in the EVL group. Although the probability of rebleeding was higher in the EVL group (29.9 %) than in the TIPS group (19.4 %), the difference was not statistically significant. Three of five patients of the EVL group successfully underwent TIPS placement after treatment failure. The probability of TIPS dysfunction requiring shunt revision was 89 %. Hepatic encephalopathy was observed more often in the TIPS group (40.5 %) than in the EVL group (20.5 %; P < 0.05). The probability of survival was similar in both groups (TIPS group 75.9 %, EVL group 82.2 %; n.s.).
Conclusions: In view of its good efficacy and the lower cost of treatment, endoscopic ligation plus propranolol may be recommended as initial procedure for prevention of recurrent variceal hemorrhage, whereas TIPS seems to be the preferable procedure in patients with recurrent bleeding after adequate endoscopic and pharmacological treatment.

References

• 1 Bosch J. Medical treatment of portal hypertension.  Digestion. 1998;  59 547-555
• 2 D'Amico G, Pagliaro L, Bosch J. The treatment of portal hypertension: A meta-analytic review.  Hepatology. 1995;  22 332-354
• 3 Bosch J, Garcia-Pagan J C, Feu F, Rodes J. Portal hypertension: Clinical pathobiology. In: Arias IM, Boyer JL, Fausto N, et al. (eds) The liver: Biology and pathobiology. New York; Raven Press 1994: 1343-1355
• 4 Stiegmann G V, Goff J S, Michaletz-Onody P A. et al . Endoscopic sclerotherapy as compared with endoscopic ligation for bleeding esophageal varices.  N Engl J Med. 1992;  326 1521-1527
• 5 Laine L, Cook D. Endoscopic ligation compared with sclerotherapy for treatment of esophageal variceal bleeding. A meta-analysis.  Ann Intern Med. 1995;  123 280-287
• 6 Sarin S K, Govil A, Jain A K. et al . Prospective randomized trial of endoscopic sclerotherapy versus variceal band ligation for esophageal varices: Influence on gastropathy, gastric varices and variceal recurrence.  J Hepatol. 1997;  26 826-832
• 7 Avgerinos A, Armonis A, Manolakopoulos S. et al . Endoscopic sclerotherapy versus variceal ligation in the long-term management of patients with cirrhosis after variceal bleeding. A prospective randomized study.  J Hepatol. 1997;  26 1034-1041
• 8 Baroncini D, Milandri G L, Borioni D. et al . A prospective randomized trial of sclerotherapy versus ligation in the elective treatment of bleeding esophageal varices.  Endoscopy. 1997;  29 235-240
• 9 Sanyal A J, Freedman A M, Purdum P P. et al . Transjugular intrahepatic portosystemic shunts compared with endoscopic sclerotherapy for the prevention of recurrent variceal hemorrhage: A randomized prospective trial.  Ann Intern Med. 1997;  126 849-857
• 10 Cabrera J, Maynar M, Granados R. et al . Transjugular intrahepatic portosystemic stent shunt versus sclerotherapy in the elective treatment of variceal hemorrhage.  Gastroenterology. 1996;  110 832-839
• 11 Cello J P, Ring E J, Olcott E W. et al . Endoscopic sclerotherapy compared with percutaneous transjugular intrahepatic portosystemic shunt after initial sclerotherapy in patients with acute variceal hemorrhage.  Ann Intern Med. 1997;  126 858-865
• 12 Garcia-Villareal L, Martinez-Lagares F, Siebra A. et al . Transjugular intrahepatic portosystemic shunt versus endoscopic sclerotherapy for the prevention of variceal rebleeding after recent variceal hemorrhage.  Hepatology. 1999;  29 27-32
• 13 Rössle M, Deibert P, Haag K. et al . Randomised trial of transjugular intrahepatic portosystemic stent shunt versus endoscopy plus propranolol for variceal rebleeding.  Lancet. 1997;  349 1043-1049
• 14 Sauer P, Theilmann L, Stremmel W. et al . Transjugular intrahepatic portosystemic stent shunt versus sclerotherapy plus propranolol for variceal rebleeding.  Gastroenterology. 1997;  113 1623-1631
• 15 Merli M, Salerno F, Riggio O. et al . Transjugular intrahepatic portosystemic shunt versus endoscopic sclerotherapy for the prevention of variceal bleeding in cirrhosis: A randomized multicenter trial. Gruppo Italiano Studio TIPS (G.I.S.T).  Hepatology. 1998;  27 48-53
• 16 Jalan R, Forrest E H, Stanley A J. et al . A randomized trial comparing transjugular intrahepatic porto systemic stent shunt with variceal band ligation in the prevention of rebleeding from esophageal varices.  Hepatology. 1997;  26 1115-1122
• 17 Pomier-Layrargues G, Villeneuve J P, Deschenes M. et al . Transjugular intrahepatic portosystemic shunt (TIPS) versus endoscopic variceal ligation in the prevention of variceal rebleeding in patients with cirrhosis: A randomised trial.  Gut. 2001;  48 390-396
• 18 Papatheodoridis G V, Goulis J, Leandro G. et al . Transjugular intrahepatic portosystemic shunt compared with endoscopic treatment for prevention of variceal rebleeding: A meta-analysis.  Hepatology. 1999;  30 612-622
• 19 Luca A, D'Amico G, LaGalla R. et al . TIPS for prevention of recurrent bleeding in patients with cirrhosis: A meta-analysis of randomized trials.  Radiology. 1999;  212 411-421
• 20 Tait I S, Krige J EJ, Terblanche J. Endoscopic band ligation of esophageal varices.  Br J Surg. 1999;  86 437-446
• 21 Richter G M, Noeldge G, Palmaz J C. et al . Transjugular intrahepatic portocaval stent shunt. Preliminary clinical results.  Radiology. 1990;  174 1027-1030
• 22 DeFranchis R, Pascal J P, Ancona E. et al . Definitions, methodology and therapeutic strategies in portal hypertension.  J Hepatol. 1992;  15 256-261
• 23 Conn H O. Trailmarking and number connection tests in the assessment of mental state in portal systemic encephalopathy.  Dig Dis. 1977;  22 541-550
• 24 Merkel M, Morabito A. Adding beta-blockers to sclerotherapy in the prevention of variceal rebleeding. A meta-analysis assessment.  J Hepatol. 1994;  21 918-919
• 25 Bosch J, Garcia-Pagan J C. Complications of cirrhosis I. Portal hypertension.  J Hepatol. 2000;  32 141-156
• 26 Lo G H, Lai K H, Cheng J S. et al . Endoscopic variceal ligation plus nadolol and sucralfate compared with ligation alone for the prevention of variceal rebleeding: A prospective randomized trial.  Hepatology. 2000;  32 461-465
• 27 Merkel C, Bolognesi M, Sacerdoti D. et al . The heodynamic response to medical treatment of portal hypertension as a predictor of clinical effectivness in the primary prophylaxis of variceal bleeding in cirrhosis.  Hepatology. 2000;  32 930-934
• 28 Bohnacker S, Maydeo A, Soehendra N. Variceal bleeding and portal hypertension: Still a therapeutic challenge.  Endoscopy. 1999;  31 26-37
• 29 Lo G H, Lai K H, Cheng J S. et al . The additive effect of sclerotherapy to patients receiving repeated endoscopic variceal ligation: A prospective, randomized trial.  Hepatology. 1998;  28 391-395
• 30 Djurdjevic D, Janosevic S, Dapcevic B. et al . Combined ligation and sclerotherapy versus ligation alone for eradication of bleeding esophageal varices: A randomized and prospective study.  Endoscopy. 1999;  31 286-290
• 31 Garg P K, Joshi Y K, Tandon R K. Comparison of endoscopic variceal sclerotherapy with sequential endoscopic band ligation plus low-dose sclerotherapy for secondary prophylaxis of variceal hemorrhage: A prospective randomized study.  Gastrointest Endosc. 1999;  50 369-373
• 32 Saeed Z A, Stiegmann G V, Ramirez F C. et al . Endoscopic variceal ligation is superior to combined ligation and sclerotherapy for esophageal varices: A multicenter prospective randomized trial.  Hepatology. 1997;  25 71-74
• 33 Graham D Y, Smith J L. The course of patients after variceal hemorrhage.  Gastroenterology. 1981;  80 800-809
• 34 Pagliaro L, D'Amico G, Pasta L. et al .Portal hypertension in cirrhosis: Natural history. In: Bosch J, Groszmann R, editors Portal hypertension: Pathophysiology and treatment. Cambridge, MA; Blackwell Scientific 1994: 72-92
• 35 Roessle M, Haag K, Ochs A. et al . The transjugular intrahepatic portosystemic stent-shunt procedure for variceal bleeding.  N Engl J Med. 1994;  330 165-171
• 36 Lind C D, Malisch T W, Chong W K. et al . Incidence of shunt occlusion or stenosis following transjugular intrahepatic portosystemic shunt placement.  Gastroenterology. 1994;  106 1277-1283
• 37 Haskal Z J, Pentecost M J, Soulen M C. et al . Transjugular intrahepatic portosystemic shunt stenosis and revision: Early and midterm results.  AJR Am J Roentgenol. 1994;  192 231-234
• 38 Sauer P, Theilmann L, Herrmann S. et al . Phenprocoumon for prevention of shunt occlusion after transjugular intrahepatic portosystemic stent shunt: A randomized trial.  Hepatology. 1996;  24 1433-1436
• 39 Richter G M, Noeldge G, Brado M. et al . TIPSS: 10 years of clinical experience.  Rofo Fortschr Geb Roentgenstr Neuen Bildgeb Verfahr. 1998;  168 307-315
• 40 Hansmann H J, Noldge G, Leutloff U. et al . Radiologic after-care of transjugular intrahepatic stent shunt.  Radiologe. 2001;  41 884-890