Upper GI bleed: varices: TIPS prevented rebleeding better than sclerotherapy but led to more encephalopathy.

Clinical bottom line (level 1b)

  1. Patients with cirrhosis and a recent bleed from oesophageal varices who had a transjugular intrahepatic portosystemic shunt (TIPS) inserted compared with sclerotherapy were less likely to rebleed (NNT = 4 at 15 months) .
  2. However patients given TIPS were at increased risk of developing hepatic encephalopathy (NNH = 2 at 15 months) .
  3. There was no clear effect on mortality or complications.
Carbrera et al: Gastroenterology 1996; 110: 832-839
Expires October 2002

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, Spain

63 patients (aged mean 56, 68% male) with cirrhosis and acute oesophageal variceal bleeding controlled by medical therapy

Excluded if
  • bleeding not controlled by medical therapy
  • neoplastic disease
  • septicaemia
  • portal vein thrombosis
  • presence of gastric varices with active bleeding or stigmata of recent haemorrhage at first emergency endoscopy
  • episodes of chronic hepatic encephalopathy
  • severe acute alcoholic hepatitis (prothrombin time < 30%)
  • end-stage cirrhosis (2 or more of PT < 355, plasma creatinine > 2 mg/dl, bilirubin > 5mg/dl, aged > 75)

Note:
  • All patients had iv somatostatin infusion 250 µ g/hour following a bolus injection of 1 µ g/kg for 48 hours. If bleeding was not controlled, a Sengstaken-Blakemore tube was inserted.
  • Patients were randomised 3 days after control of bleeding.


    • Control Group: (n = 32, 32 analysed): sclerotherapy using 1% polidocanol weekly for the first month and then every 1 to 3 months until obliteration
    Experimental Group: (n = 31, 31 analysed): transjugular intrahepatic portosystemic shunt insertion

    100% followed for 15 months (range 2 to 34 months)
    Outcome notes:
    • rebleeding : active bleeding or stigmata of recent bleeding on endoscopy
    • complications : TIPS: heart failure, portal thrombosis, pneumonia, spontaneous bacterial peritonitis; sclerotherapy: bleeding oesophageal ulcers, stenosis, pneumonia, spontaneous bacterial peritonitis

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    rebleeding 15 months 16
    (50.0%)    		 7
    (22.6%)    		 55%
    (6% to 78%)    		 27.42%
    (4.69% to 50.2%)    		 4
    (2 to 21)
    death 15 months 6
    (18.8%)    		 5
    (16.1%)    		 14%
    (-153% to 71%)    		 2.62%
    (-16.1% to 21.34%)    		 38
    (NNT = 6 to infinity;
    NNH = 5 to infinity)
    complications 15 months 11
    (34.4%)    		 7
    (22.6%)    		 34%
    (-47% to 71%)    		 11.79%
    (-10.28% to 33.87%)    		 8
    (NNT = 10 to infinity;
    NNH = 3 to infinity)
    new or worsening hepatic encephalopathy 15 months 4
    (12.5%)    		 13
    (41.9%)    		 -235%
    (-817% to -23%)    		 -29.44%
    (-50.25% to -8.63%)    		 -3
    (-12 to -2)

    Comments

    1. The study is too small to show any difference in mortality or complications between the two groups.

    Citation

    1. Carbrera J, Maynar M, Granados R, et al: Transjugular intrahepatic portosystemic shunt versus sclerotherapy in the elective treatment of variceal hemorrhage. Gastroenterology 1996; 110: 832-839
    Contributor: Chris Ball and Musab Hayatli, October 1999
    Reviewer:

    Clinical Question.
    Patient cirrhosis, and a recent bleed from oesophageal varices
    Intervention or Exposure transjugular intrahepatic portosystemic shunt (TIPS)
    Comparison injection sclerotherapy
    Outcome rebleeding, death, complications, hepatic encephalopathy