An evaluation of emergency sclerotheraphy of varices in randomized trials: Looking the needle in the eye

Endoscopy

Volumn 38, Issue 8, 2006, Pages 797-808

  Triantos, C K ^a   Goulis, J ^a   Patch, D ^a   Papatheodoridis, G V ^a   Leandro, G ^a   Samonakis, D ^a   Cholongitas, E ^a   Burroughs, Andrew K ^a  

^a ROYAL FREE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

OCTREOTIDE; SOMATOSTATIN; TERLIPRESSIN; VASOACTIVE AGENT; VASOCONSTRICTOR AGENT; VASOPRESSIN;

ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; EMERGENCY TREATMENT; ESOPHAGUS VARICES BLEEDING; GOLD STANDARD; HEMOSTASIS; HUMAN; INTERMETHOD COMPARISON; LIGATION; LIVER CIRRHOSIS; META ANALYSIS; PRIORITY JOURNAL; RISK REDUCTION; SCLEROTHERAPY; STATISTICAL SIGNIFICANCE; SURVIVAL RATE; SYSTEMATIC REVIEW; THERAPY EFFECT; CONTROLLED CLINICAL TRIAL; ESOPHAGUS VARICES; GASTROINTESTINAL HEMORRHAGE; RANDOMIZED CONTROLLED TRIAL; STATISTICS;

EMERGENCY TREATMENT; ESOPHAGEAL AND GASTRIC VARICES; GASTROINTESTINAL HEMORRHAGE; HUMANS; RANDOMIZED CONTROLLED TRIALS; SCLEROTHERAPY;

EID: 33748189379     PISSN: 0013726X     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2006-944566     Document Type: Article

References (81)

1. The North Italian Endoscopic Club for the Study and Treatment of Esophageal Varices. Prediction of the first variceal hemorrhage in patients with cirrhosis of the liver and esophageal varices. A prospective multicenter study. N Engl J Med 1988; 319: 983-989
2. McCormick PA, O'Keefe C. Improving prognosis following a first variceal haemorrhage over four decades. Gut 2001; 49: 682-685
3. Soares-Weiser K, Brezis M, Tur-Kaspa R et al. Antibiotic prophylaxis for cirrhotic patients with gastrointestinal bleeding [review]. Cochrane Database Syst Rev 2002; 2: CD002907
4. Hou MC, Lin HC, Liu TT et al. Antibiotic prophylaxis after endoscopic therapy prevents rebleeding in acute variceal hemorrhage: a randomized trial. Hepatology 2004; 39: 746-753
5. Goulis J, Patch D, Burroughs AK. Bacterial infection in the pathogenesis of variceal bleeding. Lancet 1999; 353: 139-142
6. Crafoord C, Frenckner P. New surgical treatment of varicose veins of the oesophagus. Acta Otolaryngol 1939; 27: 422-429
7. De Franchis R, Banares R, Silvain C. Emergency endoscopy strategies for improved outcomes. Scand J Gastroenterol (Suppl) 1998; 226: 25-36
8. Hartigan PM, Gebhard RL, Gregory PB. Sclerotherapy for actively bleeding esophageal varices in male alcoholics with cirrhosis. Veterans Affairs Cooperative Variceal Sclerotherapy Group. Gastrointest Endosc 1997; 46: 1-7
9. Stiegmann GV, Goff JS, Michaletz-Onody PA et al. Endoscopic sclerotherapy as compared with endoscopic ligation for bleeding esophageal varices. N Engl J Med 1992; 326: 1527-1532
10. D'Amico G, Pietrosi G, Tarantino I et al. Emergency sclerotherapy versus vasoactive drugs for variceal bleeding in cirrhosis: a Cochrane meta-analysis. Gastroenterology 2003; 124: 1277-1291
11. Triantos C, Samonakis D, Patch D et al. Sclerotherapy versus vasoactive drugs. Are all meta-analyses the same? Gastroenterology 2004; 127: 358-359
12. Alexandrino P, Alves P, Fidalgo, M et al. Is sclerotherapy the first choice treatment for active oesophageal variceal bleeding in cirrhotic patients? Final report of a randomized controlled trial [abstract]. J Hepatol 1990; 11: S1
13. Larson AW, Cohen H, Zweiban B et al. Acute esophageal variceal sclerotherapy. Results of a prospective randomized controlled trial. JAMA 1986; 255: 497-500
14. Novella M, Villanueva C, Ortiz J et al. Octreotide vs. sclerotherapy and octreotide for acute variceal bleeding. A pilot study [abstract]. Hepatology 1996; 24: 207A
15. Soderlund C, Ihre T. Endoscopic sclerotherapy v. conservative management of bleeding oesophageal varices. A 5-year prospective controlled trial of emergency and long-term treatment. Acta Chir Scand 1985; 151: 449-456
16. Villanueva C, Ortiz J, Sabat M et al. Somatostatin alone or combined with emergency sclerotherapy in the treatment of acute esophageal variceal bleeding: a prospective randomized trial. Hepatology 1999; 30: 384-389
17. Bildozola M, Kravetz D, Argonz J et al. Efficacy of octreotide and sclerotherapy in the treatment of acute variceal bleeding in cirrhotic patients. A prospective, multicentric, and randomized clinical trial. Scand J Gastroenterol 2000; 35: 419-425
18. Escorsell A, Del Arbol LR, Planas R et al. Multicenter randomized controlled trial of terlipressin versus sclerotherapy in the treatment of acute variceal bleeding: the TEST study. Hepatology 2000; 32: 471-476
19. Freitas DS, Sofia C, Pontes JM et al. Octreotide in acute bleeding esophageal varices: a prospective randomized study. Hepatogastroenterology 2000; 47: 1310-1314
20. Jenkins SA, Shields R, Davies M et al. A multicentre randomised trial comparing octreotide and injection sclerotherapy in the management and outcome of acute variceal haemorrhage. Gut 1997; 41: 526-533
21. Planas R, Quer JC, Boix J et al. A prospective randomized trial comparing somatostatin and sclerotherapy in the treatment of acute variceal bleeding. Hepatology 1994; 20: 370-375
22. Ramires RP, Zils CK, Mattos AA. Sclerotherapy versus somatostatin in the treatment of upper digestive hemorrhage caused by rupture of esophageal varices. Arq Gastroenterol 2000; 37: 148-154
23. Shields R, Jenkins SA, Baxter JN et al. A prospective randomised controlled trial comparing the efficacy of somatostatin with injection sclerotherapy in the control of bleeding oesophageal varices. J Hepatol 1992; 16: 128-137
24. Sivri B, Oksuzoglu G, Bayraktar Y et al. A prospective randomized trial from Turkey comparing octreotide versus injection sclerotherapy in acute variceal bleeding. Hepatogastroenterology 2000; 47: 168-173
25. Sung JJ, Chung SC, Lai CW et al. Octreotide infusion or emergency sclerotherapy for variceal haemorrhage. Lancet 1993; 342: 637-641
26. Westaby D, Hayes PC, Gimson AE et al. Controlled clinical trial of injection sclerotherapy for active variceal bleeding. Hepatology 1989; 9: 274-277
27. Yousuf M, Rauf A, Baig I et al. Initial management of acute variceal haemorrhage. Comparison of octreotide and sclerotherapy. J Coll Phys Surg Pak 2000; 10: 95-97
28. Di Fedo G, Siringo S, Vacirca M et al. Somatostatin (SMS) and urgent sclerotherapy (US) in active oesophageal variceal bleeding [abstract]. Gastroenterology 1990; 98: 583A
29. El-Jackie A, Rowaisha I, Waked I et al. Octreotide vs. sclerotherapy in the control of acute variceal bleeding in schistosomal portal hypertension: a randomized trial [abstract]. Hepatology 1998; 28: 553
30. Lopez F, Vargas R, Margarita G et al. Octreotide vs sclerotherapy in the treatment of acute variceal bleeding [abstract]. Hepatology 1999; 30: 574A
31. Poo J, Bosques S, Guarduno R et al. Octreotide versus emergency sclerotherapy in acute variceal hemorrhage in liver cirrhosis. A randomized multicenter study [abstract]. Gastroenterology 1996; 110: A1297
32. Avgerinos A, Nevens F, Raptis S et al. Early administration of somatostatin and efficacy of sclerotherapy in acute oesophageal variceal bleeds: the European Acute Bleeding Oesophageal Variceal Episodes (ABOVE) randomised trial. Lancet 1997; 350: 1495-1499
33. Besson I, Ingrand P, Person B et al. Sclerotherapy with or without octreotide for acute variceal bleeding. N Engl J Med 1995; 333: 555-560
34. Cales P, Masliah C, Bernard B et al. Early administration of vapreotide for variceal bleeding in patients with cirrhosis. French Club for the Study of Portal Hypertension. N Engl J Med 2001; 344: 23-28
35. Farooqi J, Farooqi R, Haq N et al. Treatment and outcome of variceal bleeding - A comparison of two methods. JCPSP 2000; 10: 131-133
36. Zuberi BF, Baloch Q. Comparison of endoscopic variceal sclerotherapy alone and in combination with octreotide in controlling acute variceal hemorrhage and early rebleeding in patients with low-risk cirrhosis. Am J Gastroenterol 2000; 95: 768-771
37. Signorelli S, Negrini F, Paris B et al. Sclerotherapy with or without somatostatin or octreotide in the treatment of acute variceal haemorrhage: our experience. Gastroenterology 1996; 110: 1326A
38. Signorelli S, Paris B, Negrini F et al. Octreotide and endoscopic variceal sclerotherapy in the management of acute variceal haemorrhage [abstract]. Endoscopy 1999; 31: E66
39. Fakhry S, Omar M, Mustafa A et al. Endoscopic sclerotherapy versus endoscopic variceal ligation in the management of bleeding esophageal varices: a final report of a prospective randomized study in schistosomal hepatic fibrosis [abstract]. Hepatology 1997; 26: 137A
40. Gimson AE, Ramage JK, Panos MZ et al. Randomised trial of variceal banding ligation versus injection sclerotherapy for bleeding oesophageal varices. Lancet 1993; 342: 391-394
41. Hou MC, Lin HC, Kuo BI et al. Comparison of endoscopic variceal injection sclerotherapy and ligation for the treatment of esophageal variceal hemorrhage: a prospective randomized trial. Hepatology 1995; 21: 1517-1522
42. Jain AK, Ray RP, Gupta J. Management of acute variceal bleed: randomized trial of variceal ligation and sclerotherapy [abstract]. Hepatology 1996; 23: 1-51
43. Jensen D, Kovacs T, Jutabha R et al. Randomized, blinded prospective study of banding vs. sclerotherapy for preventing recurrent variceal hemorrhage for patients without active bleeding at endoscopy [abstract]. Gastrointest Endosc 1993; 41: 315A
44. Laine L, el Newihi HM, Migikovsky B et al. Endoscopic ligation compared with sclerotherapy for the treatment of bleeding esophageal varices. Ann Intern Med 1993; 119: 1-7
45. Lo GH, Lai KH, Cheng JS et al. A prospective, randomized trial of sclerotherapy versus ligation in the management of bleeding esophageal varices. Hepatology 1995; 22: 466-471
46. Lo GH, Lai KH, Cheng JS et al. Emergency banding ligation versus sclerotherapy for the control of active bleeding from esophageal varices. Hepatology 1997; 25: 1101-1104
47. Salem S, Shiha G. A prospective randomized trial of sclerotherapy versus saeed six-shooter multiband ligation in the control of acute bleeding from oesophageal varices [abstract]. Gut 1999; 44 (Suppl 1): A19
48. Sarin SK, Govil A, Jain AK 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
49. Shafqat F, Khan AA, Alam A et al. Band ligation vs endoscopic sclerotherapy in esophageal varices: a prospective randomized comparison. J Pak Med Assoc 1998; 48: 192-196
50. Papatheodoridis GV, 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
51. Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988; 318: 1728-1733
52. Leandro G. Meta-analysis in medical research. Oxford: Blackwell Publishing Ltd, 2004
53. The Copenhagen Esophageal Varices Sclerotherapy Project. Sclerotherapy after first variceal hemorrhage in cirrhosis. A randomized multicenter trial. N Engl J Med 1984; 311: 1594-1600
54. El Zayadi A, ElDin SS, Kabil SM. Endoscopic sclerotherapy versus medical treatment for bleeding esophageal varices in patients with schistosomal liver disease. Gastrointest Endosc 1988; 34: 314-317
55. Escorsell A, Bordas JM, del Arbol LR et al. Randomized controlled trial of sclerotherapy versus somatostatin infusion in the prevention of early rebleeding following acute variceal hemorrhage in patients with cirrhosis. Variceal Bleeding Study Group. J Hepatol 1998; 29: 779-788
56. Primignani M, Andreoni B, Carpinelli L et al. Sclerotherapy plus octreotide versus sclerotherapy alone in the prevention of early rebleeding from esophageal varices: a randomized, double-blind, placebo-controlled, multicenter trial. New Italian Endoscopic Club. Hepatology 1995; 21: 1322-1327
57. Burroughs AK. International Octreotide Varices Study Group. Double blind RCT of 5 day octreotide versus placebo, associated with sclerotherapy for trial failures [abstract]. Hepatology 1996; 24: 325A
58. Moreto M, Zaballa M, Ruiz-Rebollo L et al. Somatostatin as an adjuvant to emergency sclerotherapy of bleeding esophageal varices [abstract]. Gut 1994; 35: A178
59. Abd-Elrazec W, Omar N, Khalil M et al. Urgent endoscopy vs. octreotide in the management of acute variceal bleeding in patients with advanced encephalopathy [abstract]. J Hepatol 2005; 42 (Suppl): 87
60. 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
61. Baroncini D, Milandri GL, 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
62. Jensen DM, Kovacs T, Jutabha R et al. Randomized, blinded prospective study of banding vs. sclerotherapy for preventing recurrent variceal hemorrhage for patients without active bleeding at endoscopy [abstract]. Gastrointest Endosc 1995; 41: 315A
63. Masci E, Norberto L, D'Imperio N et al. Prospective multicentric randomized trial comparing banding ligation with sclerotherapy of esophageal varices. Gastrointest Endosc. 1997; 45: 847A
64. Mundo F, Mitrani C, Rodriguez G, Farca A. Endoscopic variceal treatment, is band ligation taking over sclerotherapy? [abstract] Am J Gastroenterol 1993; 88: 1493A
65. Serwah AA, Habba MR, AbdelHamid AS. Endoscopic variceal ligation compared with endoscopic sclerotherapy for bleeding oesophageal varices: a randomised controlled trial [abstract]. J Hepatol 2004; 40 (Suppl 1): 73
66. Villanueva C, Minana J, Ortiz J et al. Endoscopic ligation compared with combined treatment with nadolol and isosorbide mononitrate to prevent recurrent variceal bleeding. N Engl J Med 2001; 345: 647-655
67. De Franchis R. Somatostatin, somatostatin analogues and other vasoactive drugs in the treatment of bleeding oesophageal varices. Dig Liver Dis 2004; 36 (Suppl 1): S93-S100
68. Banares R, Albillos A, Rincon D et al. Endoscopic treatment versus endoscopic plus pharmacologic treatment for acute variceal bleeding: a meta-analysis. Hepatology 2002; 35: 609-615
69. Makuch RW, Pledger G, Hall DB et al. Active control equivalence studies. In: Peace K, editor. Statistical issues in drug research and development. New York: Marcel Dekker, 1990: 225-262
70. Jones B, Jarvis P, Lewis JA et al. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996; 313: 36-39
71. Altman DG. Octreotide infusion versus injection sclerotherapy. Lancet 1993; 342: 1486
72. Grace ND, Groszmann RJ, Garcia-Tsao G et al. Portal hypertension and variceal bleeding: an AASLD single topic symposium. Hepatology 1998; 28: 868-880
73. Chan LY, Sung JJ. Review article: the role of pharmaco-therapy for acute variceal haemorrhage in the era of endoscopic haemostasis. Aliment Pharmacol Ther 1997; 11: 45-50
74. Burroughs AK, Patch D. Therapeutic benefit of vaso-active drugs for acute variceal bleeding: a real pharmacological effect, or a side-effect of definitions in trials? Hepatology 1996; 24: 737-739
75. De Franchis R. Updating consensus in portal hypertension: report of the Baveno III Consensus Workshop on definitions, methodology and therapeutic strategies in portal hypertension. J Hepatol 2000; 33: 846-852
76. Burroughs AK, McCormick PA, Hughes MD et al. Randomized, double-blind, placebo-controlled trial of somatostatin for variceal bleeding. Emergency control and prevention of early variceal rebleeding. Gastroenterology 1990; 99: 1388-1395
77. Burroughs AK. Assessment of value of consensus definitions in acute variceal bleeding. Lancet 2001; 357: 1147-1148
78. Shimm DS, Spece RG Jr. Industry reimbursement for entering patients into clinical trials: legal and ethical issues. Ann Intern Med 1991; 115: 148-151
79. Sung JJ, Chung SC, Yung MY et al. Prospective randomised study of effect of octreotide on rebleeding from oesophageal varices after endoscopic ligation. Lancet 1995; 346: 1666-1669
80. Laine L. Ligation: endoscopic treatment of choice for patients with bleeding esophageal varices? Hepatology 1995; 22: 663-665
81. Sauerbruch T, Schepke M. Sclerotherapy is out - nearly. Endoscopy 1997; 29: 281-282