Skip to main content
Gut logoLink to Gut
. 1997 Oct;41(4):526–533. doi: 10.1136/gut.41.4.526

A multicentre randomised trial comparing octreotide and injection sclerotherapy in the management and outcome of acute variceal haemorrhage

S Jenkins 1, R Shields 1, M Davies 1, E Elias 1, A Turnbull 1, M Bassendine 1, O James 1, J Iredale 1, S Vyas 1, M Arthur 1, A Kingsnorth 1, R Sutton 1
PMCID: PMC1891518  PMID: 9391254

Abstract

Background—Few studies have compared vasoactive drugs with endoscopic sclerotherapy in the control of acute variceal haemorrhage. Octreotide is widely used for this purpose, but its value remains undetermined. 
Aims—To compare octreotide with endoscopic sclerotherapy for acute variceal haemorrhage. 
Patients—Consecutive patients with acute variceal haemorrhage. 
Methods—Patients were randomised at endoscopy to receive either a 48 hour intravenous infusion of 50 µg/h octreotide (n=73), or emergency sclerotherapy (n=77). 
Results—Overall control of bleeding and mortality was not significantly different between octreotide (85%, 62 patients) and sclerotherapy (82%, 63 patients) over the 48 hour trial period (relative risk of rebleeding 0.83; 95% confidence interval (CI) 0.38 to 1.82), irrespective of Child's grading or active bleeding at endoscopy. One major complication was observed in the sclerotherapy group (aspiration) and two in the octreotide group (pulmonary oedema, severe paralytic ileus). During 60 days of follow up there was an overall trend towards an increased mortality in the octreotide group which was not statistically significant (relative risk of dying at 60 days 1.91, 95% CI 0.97 to 3.78, p=0.06). 
Conclusions—The results of this study indicate that intravenous octreotide is as effective as injection sclerotherapy in the control of acute variceal bleeding, but further controlled trials are necessary to evaluate the safety of this treatment. 



Keywords: variceal haemorrhage; octreotide; injection sclerotherapy

Full Text

The Full Text of this article is available as a PDF (139.8 KB).

Figure 1 .

Figure 1

: Kaplan-Meier plots for times to rebleeding after initiation of therapy in the sclerotherapy (INJ) and octreotide (OCT) groups. Time zero indicates the commencement of therapy.

Figure 2 .

Figure 2

: Kaplan-Meier plots for time to rebleeding after sclerotherapy (INJ/AB) or octreotide (OCT/AB) in patients with Child's A or B liver diseases and in patients with Child's C liver function in the sclerotherapy (INJ/C) and octreotide (OCT/C) groups are plotted separately. Time zero indicates commencement of therapy.

Figure 3 .

Figure 3

: Kaplan-Meier survival plots for patients randomised to receive injection sclerotherapy (INJ) or octreotide (OCT). Time zero indicates the commencement of therapy.

Figure 4 .

Figure 4

: Kaplan-Meier survival plots for patients with Child's A and B liver disease randomised to receive sclerotherapy (INJ/AB) or octreotide (OCT/AB). The survival of patients with severe liver disease (Child's C) in either the sclerotherapy (INJ/C) or octreotide (OCT/C) group was plotted separately. Time zero indicates the commencement of therapy.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Avgerinos A., Klonis C., Rekoumis G., Gouma P., Papadimitriou N., Raptis S. A prospective randomized trial comparing somatostatin, balloon tamponade and the combination of both methods in the management of acute variceal haemorrhage. J Hepatol. 1991 Jul;13(1):78–83. doi: 10.1016/0168-8278(91)90867-b. [DOI] [PubMed] [Google Scholar]
  2. Bagarani M., Albertini V., Anzà M., Barlattani A., Bracci F., Cucchiara G., Gizzonio D., Grassini G., Mari T., Procacciante F. Effect of somatostatin in controlling bleeding from esophageal varices. Ital J Surg Sci. 1987;17(1):21–26. [PubMed] [Google Scholar]
  3. Bosch J., Groszmann R. J., García-Pagán J. C., Terés J., García-Tsao G., Navasa M., Mas A., Rodés J. Association of transdermal nitroglycerin to vasopressin infusion in the treatment of variceal hemorrhage: a placebo-controlled clinical trial. Hepatology. 1989 Dec;10(6):962–968. doi: 10.1002/hep.1840100612. [DOI] [PubMed] [Google Scholar]
  4. Burroughs A. K., McCormick P. A., Hughes M. D., Sprengers D., D'Heygere F., McIntyre N. Randomized, double-blind, placebo-controlled trial of somatostatin for variceal bleeding. Emergency control and prevention of early variceal rebleeding. Gastroenterology. 1990 Nov;99(5):1388–1395. doi: 10.1016/0016-5085(90)91166-4. [DOI] [PubMed] [Google Scholar]
  5. Freeman J. G., Cobden I., Record C. O. Placebo-controlled trial of terlipressin (glypressin) in the management of acute variceal bleeding. J Clin Gastroenterol. 1989 Feb;11(1):58–60. doi: 10.1097/00004836-198902000-00014. [DOI] [PubMed] [Google Scholar]
  6. García-Escribano C., Díez-Marqués M. L., González-Rubio M., Rodríguez-Puyol M., Rodríguez-Puyol D. Somatostatin antagonizes angiotensin II effects on mesangial cell contraction and glomerular filtration. Kidney Int. 1993 Feb;43(2):324–333. doi: 10.1038/ki.1993.50. [DOI] [PubMed] [Google Scholar]
  7. Gimson A. E., Ramage J. K., Panos M. Z., Hayllar K., Harrison P. M., Williams R., Westaby D. Randomised trial of variceal banding ligation versus injection sclerotherapy for bleeding oesophageal varices. Lancet. 1993 Aug 14;342(8868):391–394. doi: 10.1016/0140-6736(93)92812-8. [DOI] [PubMed] [Google Scholar]
  8. Gimson A. E., Westaby D., Hegarty J., Watson A., Williams R. A randomized trial of vasopressin and vasopressin plus nitroglycerin in the control of acute variceal hemorrhage. Hepatology. 1986 May-Jun;6(3):410–413. doi: 10.1002/hep.1840060314. [DOI] [PubMed] [Google Scholar]
  9. Gimson A. E., Westaby D., Hegarty J., Watson A., Williams R. A randomized trial of vasopressin and vasopressin plus nitroglycerin in the control of acute variceal hemorrhage. Hepatology. 1986 May-Jun;6(3):410–413. doi: 10.1002/hep.1840060314. [DOI] [PubMed] [Google Scholar]
  10. Ginès A., Escorsell A., Ginès P., Saló J., Jiménez W., Inglada L., Navasa M., Clària J., Rimola A., Arroyo V. Incidence, predictive factors, and prognosis of the hepatorenal syndrome in cirrhosis with ascites. Gastroenterology. 1993 Jul;105(1):229–236. doi: 10.1016/0016-5085(93)90031-7. [DOI] [PubMed] [Google Scholar]
  11. Ginès A., Salmerón J. M., Ginès P., Jiménez W., Saló J., Piera C., Clària J., Rivera F., Arroyo V., Rodés J. Effects of somatostatin on renal function in cirrhosis. Gastroenterology. 1992 Dec;103(6):1868–1874. doi: 10.1016/0016-5085(92)91446-b. [DOI] [PubMed] [Google Scholar]
  12. Hanisch E., Doertenbach J., Usadel K. H. Somatostatin in acute bleeding oesophageal varices. Pharmacology and rationale for use. Drugs. 1992;44 (Suppl 2):24–72. doi: 10.2165/00003495-199200442-00005. [DOI] [PubMed] [Google Scholar]
  13. Hwang S. J., Lin H. C., Chang C. F., Lee F. Y., Lu C. W., Hsia H. C., Wang S. S., Lee S. D., Tsai Y. T., Lo K. J. A randomized controlled trial comparing octreotide and vasopressin in the control of acute esophageal variceal bleeding. J Hepatol. 1992 Nov;16(3):320–325. doi: 10.1016/s0168-8278(05)80663-4. [DOI] [PubMed] [Google Scholar]
  14. Jaramillo J. L., de la Mata M., Miño G., Costán G., Gómez-Camacho F. Somatostatin versus Sengstaken balloon tamponade for primary haemostasia of bleeding esophageal varices. A randomized pilot study. J Hepatol. 1991 Jan;12(1):100–105. doi: 10.1016/0168-8278(91)90917-z. [DOI] [PubMed] [Google Scholar]
  15. Jenkins S. A., Baxter J. N., Corbett W. A., Shields R. Effects of a somatostatin analogue SMS 201-995 on hepatic haemodynamics in the pig and on intravariceal pressure in man. Br J Surg. 1985 Dec;72(12):1009–1012. doi: 10.1002/bjs.1800721225. [DOI] [PubMed] [Google Scholar]
  16. Jenkins S. A., Baxter J. N., Corbett W., Devitt P., Ware J., Shields R. A prospective randomised controlled clinical trial comparing somatostatin and vasopressin in controlling acute variceal haemorrhage. Br Med J (Clin Res Ed) 1985 Jan 26;290(6464):275–278. doi: 10.1136/bmj.290.6464.275. [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Kravetz D., Bosch J., Terés J., Bruix J., Rimola A., Rodés J. Comparison of intravenous somatostatin and vasopressin infusions in treatment of acute variceal hemorrhage. Hepatology. 1984 May-Jun;4(3):442–446. doi: 10.1002/hep.1840040315. [DOI] [PubMed] [Google Scholar]
  18. Laine L., el-Newihi H. M., Migikovsky B., Sloane R., Garcia F. Endoscopic ligation compared with sclerotherapy for the treatment of bleeding esophageal varices. Ann Intern Med. 1993 Jul 1;119(1):1–7. doi: 10.7326/0003-4819-119-1-199307010-00001. [DOI] [PubMed] [Google Scholar]
  19. Lin C. I., Wei J., Cheng K. K., Ho L. T. Electropharmacological effects of sandostatin in human atrial fibers. Int J Cardiol. 1991 Jun;31(3):313–318. doi: 10.1016/0167-5273(91)90382-y. [DOI] [PubMed] [Google Scholar]
  20. Lo G. H., Lai K. H., Chang C. F., Shen M. T., Jeng J. S., Huang R. L., Hwu J. H. Endoscopic injection sclerotherapy vs. endoscopic variceal ligation in arresting acute variceal bleeding for patients with advanced hepatocellular carcinoma. J Hepatol. 1994 Dec;21(6):1048–1052. doi: 10.1016/s0168-8278(05)80616-6. [DOI] [PubMed] [Google Scholar]
  21. Loperfido S., Godena F., Tosolini G., Demattè P., Burei F., Gasparini G., Sartori C., Valbusa A., Bulfoni A., Buttolo Q. La somatostatina nel trattamento dell'emorragia da varici esofago-gastriche. Sperimentazione clinica controllata in confronto a ranitidina. Recenti Prog Med. 1987 Feb;78(2):82–86. [PubMed] [Google Scholar]
  22. McCormick P. A., Chin J., Greenslade L., Karatapanis S., Dick R., McIntyre N., Burroughs A. K. Cardiovascular effects of octreotide in patients with hepatic cirrhosis. Hepatology. 1995 May;21(5):1255–1260. [PubMed] [Google Scholar]
  23. McCormick P. A., Kaye G. L., Greenslade L., Cardin F., Hobbs K. E., McIntyre N., Burroughs A. K. Esophageal staple transection as a salvage procedure after failure of acute injection sclerotherapy. Hepatology. 1992 Mar;15(3):403–406. doi: 10.1002/hep.1840150308. [DOI] [PubMed] [Google Scholar]
  24. McKee R. A study of octreotide in oesophageal varices. Digestion. 1990;45 (Suppl 1):60–65. doi: 10.1159/000200264. [DOI] [PubMed] [Google Scholar]
  25. Minocha A., Dean H. A., Jr Octreotide-induced acute hepatic toxicity. Am J Gastroenterol. 1991 Apr;86(4):525–525. [PubMed] [Google Scholar]
  26. Mountokalakis T., Kallivretakis N., Mayopoulou-Symvoulidou D., Karvountzis G., Tolis G. Enhancement of renal function by a long-acting somatostatin analogue in patients with decompensated cirrhosis. Nephrol Dial Transplant. 1988;3(5):604–607. doi: 10.1093/oxfordjournals.ndt.a091713. [DOI] [PubMed] [Google Scholar]
  27. Rector W. G., Jr Drug therapy for portal hypertension. Ann Intern Med. 1986 Jul;105(1):96–107. doi: 10.7326/0003-4819-105-1-96. [DOI] [PubMed] [Google Scholar]
  28. Saari A., Klvilaakso E., Inberg M., Päkkönen M., Lahtinen J., Höckerstedt K., Schröder T. Comparison of somatostatin and vasopressin in bleeding esophageal varices. Am J Gastroenterol. 1990 Jul;85(7):804–807. [PubMed] [Google Scholar]
  29. Sarin S. K., Sachdev G., Nanda R., Batra S. K., Anand B. S. Comparison of the two time schedules for endoscopic sclerotherapy: a prospective randomised controlled study. Gut. 1986 Jun;27(6):710–713. doi: 10.1136/gut.27.6.710. [DOI] [PMC free article] [PubMed] [Google Scholar]
  30. Shields R., Jenkins S. A., Baxter J. N., Kingsnorth A. N., Ellenbogen S., Makin C. A., Gilmore I., Morris A. I., Ashby D., West C. R. A prospective randomised controlled trial comparing the efficacy of somatostatin with injection sclerotherapy in the control of bleeding oesophageal varices. J Hepatol. 1992 Sep;16(1-2):128–137. doi: 10.1016/s0168-8278(05)80105-9. [DOI] [PubMed] [Google Scholar]
  31. Stiegmann G. V., Goff J. S., Michaletz-Onody P. A., Korula J., Lieberman D., Saeed Z. A., Reveille R. M., Sun J. H., Lowenstein S. R. Endoscopic sclerotherapy as compared with endoscopic ligation for bleeding esophageal varices. N Engl J Med. 1992 Jun 4;326(23):1527–1532. doi: 10.1056/NEJM199206043262304. [DOI] [PubMed] [Google Scholar]
  32. Sung J. J., Chung S. C., Lai C. W., Chan F. K., Leung J. W., Yung M. Y., Kassianides C., Li A. K. Octreotide infusion or emergency sclerotherapy for variceal haemorrhage. Lancet. 1993 Sep 11;342(8872):637–641. doi: 10.1016/0140-6736(93)91758-e. [DOI] [PubMed] [Google Scholar]
  33. Söderlund C., Magnusson I., Törngren S., Lundell L. Terlipressin (triglycyl-lysine vasopressin) controls acute bleeding oesophageal varices. A double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol. 1990 Jun;25(6):622–630. doi: 10.3109/00365529009095539. [DOI] [PubMed] [Google Scholar]
  34. Terblanche J., Bornman P. C., Kahn D., Jonker M. A., Campbell J. A., Wright J., Kirsch R. Failure of repeated injection sclerotherapy to improve long-term survival after oesophageal variceal bleeding. A five-year prospective controlled clinical trial. Lancet. 1983 Dec 10;2(8363):1328–1332. doi: 10.1016/s0140-6736(83)91090-5. [DOI] [PubMed] [Google Scholar]
  35. Terblanche J., Burroughs A. K., Hobbs K. E. Controversies in the management of bleeding esophageal varices (1) N Engl J Med. 1989 May 25;320(21):1393–1398. doi: 10.1056/NEJM198905253202107. [DOI] [PubMed] [Google Scholar]
  36. Valenzuela J. E., Schubert T., Fogel M. R., Strong R. M., Levine J., Mills P. R., Fabry T. L., Taylor L. W., Conn H. O., Posillico J. T. A multicenter, randomized, double-blind trial of somatostatin in the management of acute hemorrhage from esophageal varices. Hepatology. 1989 Dec;10(6):958–961. doi: 10.1002/hep.1840100611. [DOI] [PubMed] [Google Scholar]
  37. Vlavianos P., Gimson A. E., Westaby D., Williams R. Balloon tamponade in variceal bleeding: use and misuse. BMJ. 1989 Apr 29;298(6681):1158–1158. doi: 10.1136/bmj.298.6681.1158. [DOI] [PMC free article] [PubMed] [Google Scholar]
  38. Walker S., Stiehl A., Raedsch R., Kommerell B. Terlipressin in bleeding esophageal varices: a placebo-controlled, double-blind study. Hepatology. 1986 Jan-Feb;6(1):112–115. doi: 10.1002/hep.1840060121. [DOI] [PubMed] [Google Scholar]
  39. Westaby D. The management of active variceal bleeding. Intensive Care Med. 1988;14(2):100–105. doi: 10.1007/BF00257459. [DOI] [PubMed] [Google Scholar]

Articles from Gut are provided here courtesy of BMJ Publishing Group

RESOURCES