Upper GI bleed: varices: TIPS was more effective than banding at preventing rebleeds

Clinical bottom line (level 1b)

  1. Patients with a recent bleed from oesophageal varices who had a transjugular intrahepatic portosystemic shunt (TIPS) inserted compared with a course of sclerotherapy were less likely to rebleed (NNT = 2 at 16 months)
  2. There was no clear effect on mortality, occurrence of hepatic encephalopathy or sepsis.
Jalan et al: Hepatology 1997; 26: 1115-1122
Expires October 2002

The study

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

58 patients (aged mean 57, 64% male) with cirrhosis and endoscopically-proven variceal haemorrhage

Excluded if
  • previous endoscopic treatment for variceal bleeding
  • hepatorenal failure
  • hepatic or extrahepatic malignancy
  • portal vein thrombosis (on colour flow doppler)
  • rebleeding from varices within 24 hours of endoscopy
  • bleeding from ectopic varices (gastric, duodenal or rectal)
  • aged <18 and >75


Note:
  • All patients had endoscopy within 6 hours of admission. If active bleeding was seen, sclerotherapy was performed; otherwise patients had variceal band ligation.
  • Patients were randomised if they were stable for 24 hours.


Control Group: (n = 27, 27 analysed): band ligation weekly until variceal eradication; and then repeated at 3-6 monthly intervals
Experimental Group: (n = 31, 31 analysed): TIPS

100% followed for 16 months
Outcome notes:
  • variceal rebleeding : hematemesis and/or melena, a reduction in Hb of >2 g/dL and requiring unscheduled endoscopy

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
variceal rebleeding 16 months 14
(51.9%)		 3
(9.68%)		 81%
(42% to 94%)		 42.17%
(20.6% to 63.7%)		 2
(2 to 5)
death 16 months 10
(37.0%)		 13
(41.9%)		 -13%
(-120% to 40%)		 -4.90%
(-30.1% to 20.3%)		 -20
(NNT = 5 to infinity;
NNH = 3 to infinity)
encephalopathy 16 months 12
(44.4%)		 11
(35.5%)		 20%
(-51% to 58%)		 8.96%
(-16.2% to 34.2%)		 11
(NNT = 3 to infinity;
NNH = 6 to infinity)
sepsis 7 days 3
(11.1%)		 4
(12.9%)		 -16%
(-370% to 72%)		 -1.79%
(-18.5% to 14.9%)		 -56
(NNT = 7 to infinity;
NNH = 5 to infinity)

Comments

  1. The study is too small too show any clear difference for mortality, hepatic encephalopathy or sepsis.
  2. TIPS insertion failed in 2 patients. 9 patients developed shunt insufficiency.

Citation

  1. Jalan R, Forrest E, Stanley AJ, et al: A randomized trial comparing transjugular intrahepatic portosystemic stent-shunt with variceal band ligation in the prevention of rebleeding from esophageal varices. Hepatology 1997; 26: 1115-1122
Contributor: Chris Ball and Musab Hayatli, October 1999
Reviewer:

Clinical Question.
    Patient oesophageal variceal bleed
    Intervention or Exposure TIPS
    Comparison banding
    Outcome death, rebleed