Elsevier

Journal of Hepatology

Volume 45, Issue 4, October 2006, Pages 560-567
Journal of Hepatology

A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding,☆☆

https://doi.org/10.1016/j.jhep.2006.05.016Get rights and content

Background/Aims

The currently recommended treatment for acute variceal bleeding is the association of vasoactive drugs and endoscopic therapy. However, which emergency endoscopic treatment combines better with drugs has not been clarified. This study compares the efficacy and safety of variceal ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin.

Methods

Patients admitted with acute gastrointestinal bleeding and with suspected cirrhosis received somatostatin infusion (for 5 days). Endoscopy was performed within 6 h and those with esophageal variceal bleeding were randomized to receive either sclerotherapy (N = 89) or ligation (N = 90).

Results

Therapeutic failure occurred in 21 patients treated with sclerotherapy (24%) and in nine treated with ligation (10%) (RR = 2.4, 95% CI = 1.1–4.9). Failure to control bleeding occurred in 15% vs 4%, respectively (P = 0.02). Treatment group, shock and HVPG >16 mmHg were independent predictors of failure. Side-effects occurred in 28% of patients receiving sclerotherapy vs 14% with ligation (RR = 1.9, 95% CI = 1.1–3.5), being serious in 13% vs 4% (P = 0.04). Six-week survival probability without therapeutic failure was better with ligation (P = 0.01).

Conclusions

The use of variceal ligation instead of sclerotherapy as emergency endoscopic therapy added to somatostatin for the treatment of acute variceal bleeding significantly improves the efficacy and safety.

Introduction

Hemostatic treatment is essential in acute esophageal variceal bleeding, a medical emergency associated with relevant morbidity and mortality [1], [2]. Available evidence suggests that emergency sclerotherapy (EST) and vasoactive drugs have a similar efficacy and survival [3], [4]. However, EST is associated with more frequent serious adverse events [4]. By combining both therapies, the local hemostatic effect induced by endoscopic treatment on the varices is added to the portal hypotensive effect achieved with drugs. This combination is the therapy of choice currently recommended for acute variceal bleeding [5], [6], [7]. The rationale for this comes from a number of trials showing that the association of vasoactive drugs improves the efficacy of endoscopic treatment [8]. Besides, the addition of EST improves the efficacy of somatostatin (SMT) although adverse events increase as well [9].

A clear advantage may be expected using endoscopic variceal banding ligation (EVL) instead of EST, considering that fewer complications are associated with EVL [10], [11]. However, the efficacy and safety of emergency EVL to treat acute variceal bleeding are poorly defined. Several trials comparing long-term EST with EVL give separate data for acute bleeding, showing no differences [11], [12]. Only two studies, both with a small sample size, have been specifically designed to compare these endoscopic therapies in acute variceal bleeding and results were contradictory [13], [14]. Vasoactive drugs were not used in these studies. However, drugs facilitate endoscopic therapy and improve the efficacy of both EST and EVL [15], [16], [17]. The present study was performed to assess the safety and efficacy of emergency EVL in comparison with EST as endoscopic therapy added to SMT for acute esophageal variceal bleeding.

Section snippets

Patient selection and study design

From July 1999 to July 2004, all patients admitted to our hospital with hematemesis and/or melena, clinical suspicion of cirrhosis and age over 18 years were considered for inclusion. Re-randomization was only allowed if a separate bleeding episode occurred at least 45 days after the previous inclusion, but not more than twice. In all potentially eligible patients, a continuous intravenous infusion of SMT was started immediately after admission. Diagnostic endoscopy was performed within the

Results

One hundred seventy-nine episodes of esophageal variceal bleeding in 168 patients were studied, with 11 reinclusions (Fig. 1). Eighty-nine patients were randomly allocated to receive SMT plus EST and 90 to receive SMT plus EVL. Base line data were similar in both groups (Table 1). A mean of 19 ± 14 ml of ethanolamine were injected in the SMT + EST group. A mean of 8 ± 2 elastic rings were placed in the SMT + EVL group.

Discussion

The present study suggests that EVL has substantial advantages over EST as emergency endoscopic therapy added to SMT for acute esophageal variceal bleeding. The current results show that EVL is safer than EST even when such endoscopic treatments are used on an emergency basis, in association with SMT. EVL is a mechanical method of obliterating varices which may avoid the systemic effects associated with EST, and since the amount of tissue ligated is limited it should also result in fewer

Acknowledgements

We thank the nursing and medical staff of the Gastrointestinal Bleeding Unit and of Semi-Critics Unit of the Hospital de la Santa Creu i Sant Pau for their cooperation in this study.

References (36)

  • J.B. Ready et al.

    Assessment of the risk of bleeding from esophageal varices by continuous monitoring of portal pressure

    Gastroenterology

    (1991)
  • E. Moitinho et al.

    Prognostic value of early measurements of portal pressure in acute variceal bleeding

    Gastroenterology

    (1999)
  • C. Villanueva et al.

    Somatostatin treatment and risk stratification by continuous portal pressure monitoring during acute variceal bleeding

    Gastroenterology

    (2001)
  • N. Chalasani et al.

    Improved patient survival after acute variceal bleeding: a multicenter, cohort study

    Am J Gastroenterol

    (2003)
  • A.K. Burroughs et al.

    Natural history and prognosis of variceal bleeding

    Baillieres Clin Gastroenterol

    (1992)
  • J. Bosch et al.

    Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: a randomized, double-blind trial

    Gastroenterology

    (2004)
  • N.D. Grace et al.

    Portal hypertension and variceal bleeding: an AASLD single topic symposium

    Hepatology

    (1998)
  • A.K. Burroughs et al.

    Management of variceal hemorrhage in cirrhotic patients

    Gut

    (2001)
  • Cited by (183)

    • ACR Appropriateness Criteria® Radiologic Management of Portal Hypertension

      2021, Journal of the American College of Radiology
    • Gastrointestinal bleeding in old age

      2024, Zeitschrift fur Gerontologie und Geriatrie
    View all citing articles on Scopus

    This study has been supported in part by a grant from the Fundació Investigació Sant Pau and by a grant from the Instituto de Salud Carlos III (CO3/02).

    ☆☆

    The authors who have taken part in this study declared that they have no relationship with the manufactures of the drugs involved either in the past or present and did not receive funding from the manufacturers to carry out their research.

    View full text