prospective randomised trial of endoscopic sclerotherapy versus oesophageal staple transection for...

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WP-D 5 THE COURSE OF PATIENTS AFTER OBLITERATION OF BLEEDING ESOPI~GEAL VARI- CES BY SCLEROTHERAPY : RESULTS OF A PROSPECTIVE STUDY. By : J.P.Vinel, P.Schuller, P.Cal~s, Ch Hervieu, J.Cassigneul, J.P.Pascal. CHU Purpan - 31059 TOULOUSE, Cedex. Endoscopic sclerotherapy (E.S.) was proved to be an efficient treatment for bleeding esophageal varices (O.V.).However little attention has been paid to the long-term follow-up of patients after O.V. had been obliterated. This prospective study aimed to investi- gate the course of patients after dnliter~ticn, and to oultine prognostic factors. Patients and methods:from january 1983 to december 1985, Ii0 patients with bleeding O.V. were treated with E.S. Complete obliteration was achieved in 67 patients (45 men-22 women-mean age=55.3Z14 years) Aetiology of portal hypertension was portal vein thrombosis in 3 and cirrhosis in 64 of whom 44 (69%) from alcoholism (Child's class A:8%-B:42%-C:SO%).They were followed for a mean of 14 months from the time obliteration. Results: i/Recurrence of O.V. was observed in 23 patients (34%) with a mean of 8.2 months.Re-obliteration was achieved with a mean of 1.8 sessions of E.S. (range 1-3).This subgroup of patients had experienced less often esophageal stenosis du- ring E.S.(34% vs 13%-p< 0,05) and had had more often several episodes of variceal bleeding be- fore E.S.(41% vs 10%-p~ O,OS) than that of patients without recurrence. 2/Variceal bleedin~ oc- cured in 14 patients (22%) with a mean of 9 months.6 died before endoscopy could be performed ; 6 bled from O.V. and 2 from esophageal ulceration. In the subgroup of patients with alcoholic cirrhosis, absence of withdrawal was associated with a higher risk of bleeding (50% vs 15~- p=0,O4).3/Death: 15 patients (22%) died with a mean of 11 months=6 from bleedingl7 from hepa- tic failure, 1 from hepatocarcinoma and 1 from myocardial infarction. These patients had a + higher mean age (64.4±9 vs 52.7-14-p<0,01) and a lower mean blood fibrinogen (1.9£0.4 vs 2.46 + . . . -0.89-p<0,05) than survivors. Conclusion:I/Patients whose O.V.had been obliterated by E.S. should have regular follow-up endoscopies at intervals of 3 months in the first year after o- bliteration. 2/ Multiple bleeding episodes before E.S., age, absence of withdrawal and poor hepatic functions were poor prognostic factors. WP-D 6 PROSPECTIVE RANDOMISED TRIAL OF ENDOSCOPIC SCLEROTHERAPY VERSUS OESOPHAGEAL STAPLE TRANSECTION FOR ACUTE VARICEAL BLEEDING. SINGLE INTERIM ANALYSIS A.K. Burroughs, F. D'Heygere, A. Phillips+, K~EtF. Hobbs*~ N. Mclntyre Academic Department of Medicine, Clinical Epidemiology + and Surgery*, Royal Free Hospital and Medical School, London, U.K. Oesophageal staple transection (OST) is reported to be 1OO% effective in stopping varice~l bleeding but has a high 30 day mortality. Studies of emergency endoscopic sclerosis (ES) report less mortality but also less efficacy compared to OST. However Grahm and Smith (Gast- roenterology 1982; 82: 968-72) found no difference in survival between medical or surgical therapy for variceal bleeding, but this was not evaluated in a controlled study. We aimed to compare OST versus ES (intravariceal 5% ethanolamine) for control of variceal bleeding in cirrhotics. Patients were randomised if bleeding was not controlled with transfusion and glypressin at any time within 5 days from admission. There were 200 admissions (125 patient@ with variceal bleeds: Pugh's grade A (47), B (80), C (73). In 82 admissions bleeding not controlled: 12 not randomised (8 not eligible, 4 moribund). 70 admissions were randomised: grade A (9), B (25), C (36), 35 to OST and 35 to ES. The two groups were matched for age, aetiology of cirrhosis, Pugh's grading and transfusion requirement before procedure. Overall mortality at 30 days was 34% (12 of 35) in both groups (I A, 4 B, 19 C) analysed by intention to treat. Mortality related to treatment received was also not significantly different (OST 27%, ES 31%). Failure to completely control bleeding was 15% in ES group (5 admissions - survival in i) using up to 3 injection sessions, versus 3% in OST group (I admission - survived). Complications per admission, due to bleeding and/or procedure were more frequent in OST group, but fatal complications were similar. These results show that OST does not have an increased mortality compared to ES. There was similar mortality between OST and ES,despite~being less effective and having a high mortality in patient failures. Prediction of ES failures and/or early transition to alter- native therapy may improve survival in acute variceal bleeding. $55

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Page 1: Prospective randomised trial of endoscopic sclerotherapy versus oesophageal staple transection for acute variceal bleeding. Single interim analysis

WP-D 5 THE COURSE OF PATIENTS AFTER OBLITERATION OF BLEEDING ESOPI~GEAL VARI- CES BY SCLEROTHERAPY : RESULTS OF A PROSPECTIVE STUDY.

By : J.P.Vinel, P.Schuller, P.Cal~s, Ch Hervieu, J.Cassigneul, J.P.Pascal. CHU Purpan - 31059 TOULOUSE, Cedex.

Endoscopic sclerotherapy (E.S.) was proved to be an efficient treatment for bleeding esophageal varices (O.V.).However little attention has been paid to the long-term follow-up of patients after O.V. had been obliterated. This prospective study aimed to investi- gate the course of patients after dnliter~ticn, and to oultine prognostic factors. Patients and methods:from january 1983 to december 1985, Ii0 patients with bleeding O.V. were treated with E.S. Complete obliteration was achieved in 67 patients (45 men-22 women-mean age=55.3Z14 years) Aetiology of portal hypertension was portal vein thrombosis in 3 and cirrhosis in 64 of whom 44 (69%) from alcoholism (Child's class A:8%-B:42%-C:SO%).They were followed for a mean of 14 months from the time obliteration. Results: i/Recurrence of O.V. was observed in 23 patients (34%) with a mean of 8.2 months.Re-obliteration was achieved with a mean of 1.8 sessions of E.S. (range 1-3).This subgroup of patients had experienced less often esophageal stenosis du- ring E.S.(34% vs 13%-p< 0,05) and had had more often several episodes of variceal bleeding be- fore E.S.(41% vs 10%-p~ O,OS) than that of patients without recurrence. 2/Variceal bleedin~ oc- cured in 14 patients (22%) with a mean of 9 months.6 died before endoscopy could be performed ; 6 bled from O.V. and 2 from esophageal ulceration. In the subgroup of patients with alcoholic cirrhosis, absence of withdrawal was associated with a higher risk of bleeding (50% vs 15~- p=0,O4).3/Death: 15 patients (22%) died with a mean of 11 months=6 from bleedingl7 from hepa- tic failure, 1 from hepatocarcinoma and 1 from myocardial infarction. These patients had a

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h i g h e r mean age (64.4±9 vs 5 2 . 7 - 1 4 - p < 0 , 0 1 ) and a lower mean b lood f i b r i n o g e n (1 .9£0 .4 vs 2 .46 + . . .

- 0 . 8 9 - p < 0 , 0 5 ) t han s u r v i v o r s . C o n c l u s i o n : I / P a t i e n t s whose O.V.had been o b l i t e r a t e d by E.S. s h o u l d have r e g u l a r f o l l o w - u p e n d o s c o p i e s a t i n t e r v a l s o f 3 months in the f i r s t y e a r a f t e r o- b l i t e r a t i o n . 2 / M u l t i p l e b l e e d i n g e p i s o d e s b e f o r e E .S . , age , absence o f wi thdrawal and poor h e p a t i c f u n c t i o n s were poor p r o g n o s t i c f a c t o r s .

WP-D 6 PROSPECTIVE RANDOMISED TRIAL OF ENDOSCOPIC SCLEROTHERAPY VERSUS OESOPHAGEAL STAPLE TRANSECTION FOR ACUTE VARICEAL BLEEDING. SINGLE INTERIM ANALYSIS A.K. Burroughs, F. D'Heygere, A. Phillips+, K~EtF. Hobbs*~ N. Mclntyre Academic Department of Medicine, Clinical Epidemiology + and Surgery*, Royal Free Hospital and Medical School, London, U.K.

Oesophageal staple transection (OST) is reported to be 1OO% effective in stopping varice~l bleeding but has a high 30 day mortality. Studies of emergency endoscopic sclerosis (ES) report less mortality but also less efficacy compared to OST. However Grahm and Smith (Gast- roenterology 1982; 82: 968-72) found no difference in survival between medical or surgical therapy for variceal bleeding, but this was not evaluated in a controlled study. We aimed to compare OST versus ES (intravariceal 5% ethanolamine) for control of variceal bleeding in cirrhotics. Patients were randomised if bleeding was not controlled with transfusion and glypressin at any time within 5 days from admission. There were 200 admissions (125 patient@ with variceal bleeds: Pugh's grade A (47), B (80), C (73). In 82 admissions bleeding not controlled: 12 not randomised (8 not eligible, 4 moribund). 70 admissions were randomised: grade A (9), B (25), C (36), 35 to OST and 35 to ES. The two groups were matched for age, aetiology of cirrhosis, Pugh's grading and transfusion requirement before procedure.

Overall mortality at 30 days was 34% (12 of 35) in both groups (I A, 4 B, 19 C) analysed by intention to treat. Mortality related to treatment received was also not significantly different (OST 27%, ES 31%). Failure to completely control bleeding was 15% in ES group (5 admissions - survival in i) using up to 3 injection sessions, versus 3% in OST group (I admission - survived). Complications per admission, due to bleeding and/or procedure were more frequent in OST group, but fatal complications were similar.

These results show that OST does not have an increased mortality compared to ES. There was similar mortality between OST and ES,despite~being less effective and having a high mortality in patient failures. Prediction of ES failures and/or early transition to alter- native therapy may improve survival in acute variceal bleeding.

$55