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Endoscopic sclerotherapy versus endoscopic variceal ligation in the management of bleeding esophageal varices: A preliminary report of a prospective randomized study in schistosomal hepatic fibrosis
HEPATOLOGY Vol. 22, N o . 4, P t . 2, 1 9 9 5
AASLD
577 ENDOSCOPIC
SCLEROTHERAPY VERSUS ENDOSCOPIC VARICEAL LIGATION IN T H E M A N A G E M E N T OF BLEEDING E S O P H A G E A L VARICES: A PRELIMINARY REPORT OF A PROSPECTIVE R A N D O M I Z E D STUDY IN S C H I S T O S O M A L HEPATIC FIBROSIS. S. F~dlrv. M Omar. A. N o u i t M. AI-Gimmlm~ M- Serrv. M. Atria I. Moustafa. N. El- Beheiry. S. Hunter. Theodore Bilharz Research Institute, and Faculty o f Medicine, Cairo University, Cairo, Egypt. This study presents initial dam from a randomizes trial comparing endoscopic s d e m t h e m p y (ES) with endoscopic variexml ligation (EVL) for the definitive treatment o f vaficeal bleeding in patients with Schistosomal hepatic fibrosis. M e t h ~ l m Previously untreated patients with active or recent variceal bleedin8 were randomized at index endoscopic examination to either ES using 5% ethanolamine oleate, or EVL. Results: 51 Patients fulfilling the inclusion criteria were randomized, 26 (51%) for EVL, and 25 (49%) for ES. Groups were well matched for age, sex, grade o f varices and Child-Pugh classification. The mean follow-up period w a s 39+1- 0.7 weeks. 10 EVL and 12 ES patients were actively bleeding at index endoscopy. W e were able to control bleeding in 9110(90°,4) in EVL Stoup and 11/12(92",4) in ES Stoup. One patient died in each group due to failure to control active bleeding. Other results are: Eradicated Numher R ~ u r r e m Rt~t.-~a~t C o m p l l e ~ o m o f S~miom Vat'ices Bleedimz ES 24/24 4.7+/-0.9 7/24 (29%) 2/24 8/24 (33%) EVL 25/25 2.8+/-0.7 8/25 (32%) 1/25 1/25 (4%) p <0.05* >0.05 >0.05 <0.05* C e a d m i e a : Our preliminary results sngsest that E V L is as effective as ES in control o f actively bleeding variees. However, the number o f sessions needed for eradication o f vafices and complications are significantly lower in the EVL 8roup.
5 7 9 ~ p h y ~ i c ~ d o ~ p i c Wried Sand Ligatm {EW) Veins Sclerethempy (ES) For The Prev~ticu of Variceal Bleeding: An Interim Report of A Prespe~ve R~domized Controlled Trial in Schisto~mml PortalHypertension. K. ~ I. Waked. S. Sal~. M. SalLm1*. S. AbdeI-F~mh*. l)epartmm~ of Medicine, Liver Institute, Shebeen EI-Kom, and Ain Shams University School of M~lieim*, Cairo; EGYPT. The role o f p ~ c endoscopic therapy for the prevemi~ of ~rst variceal bleed in p o ~ ! hypemminn remains ~ i a l . EVL has become a tteatrt~ut option with lower complication rate than ES. Aim." The aim ofthis study is to evaluate EVL as a prephyiactic ~ for the pmvmtion of esophageal variceal bleeding in hish risk varices, and compare it to pmphyinctic ES in a ~ commlled trial. Patients aml Metlm(B" Fifty con~nth~ patients (35 males, Child clam A: 12, B:25, C:! 3), with sdhim3tmtml ~ h ~ (84% with c m ~ cirdmsis due to chronic viral hepatitis) and high risk varices (grade 3-4 with red wale nmrkmgs m d l~mocys~ slp~) who Imve not bled befere w~e ~ a t ~ y : 16 received EVL, 17 ES using 5%etham31areh~ oleate as ~ and 17 patients no therepy as central group. The groups were ~ for ~ , t~x m~d Clfild-Pugh seom EVL and E$ were & m e ~ r y 2 weeks till variceal obliteration or near obliteration to less than 1+, and f o l k ~ up e n d ~ o p y was dine monthly thereafter. Results: Two patiemts died o f hepatic failure and hepatoremal syndmree, one in EVL and m e in ES. 48 Patimts were followed for 12+-4 months (4-16). Varices were obliterated in 12/15 EVL pafim~ in 2.7+-1.8 sessimm, and in 14/16 ES patiems in 5.3+-1.8 semims (obliteratinn: us, number of sessinns p<0.01). Varices .w~,,.~l in 3115 EVL and 4/16 ES (m) 2-9 nmmh~ a~er obl~ration to 2+, and were treated with the init~ method. B l e e d ~ occurred in 3 ofthe comrel 1-6 months aRer madmnizstim (1 fatal, 2 controlled by ES), and 2 in the ES gump (both before o b l ~ , t ~ a t and o3utroUed by ES), (ns). Two in the EVL vs 10 in the ES had complicatinn$ (EVL: both ulcett, ES 6 ulcers, 4 mild~'ictures) (p-.-~0.01). C m d m i m : EVL is safe as a p ~ measure in high risk varines. Data so far su88wt that it is superior to ES mid no therepy, but not ~mdumve. More patients are being included, and a m u Itk~-~-ic trial is justifiecL
ABSTRACTS
251A
578 TIPSS VS VARICEAL BAND LIGATION IN THE SECONDARY
PREVENTION OF VARICEAL HAEMORRHAGE IN CIRRHOSIS: PRELIMINARY RESULTS OF A RANDOMISED, CONTROLLED STUDY. R.Jalan, E.H.Forrest, 'D.N.Redhead J.F.Dillon, K.l.Bzeizi, *N.D.C.Finlayson, *A.J.MacGilchnst, P.C.Hayes. *Centre for Liver and Digestive Disorders, Dept of Medicine and 'Radiology, Royal Infirmary, Edinburgh. Aims: The aim of this study was to compare transjngular intrahepatic pertosystemic stent-shunt (TIPSS) and variceal band ligation (VBL) in the secondary prevention of varieeal haemorrhage in patients with cirrhosis. Patients aad Methods: Thirty nine patients with cirrhosis were randomised to TIPSS (18 patients) or VBL (21 patients), 24 hours after successful control of variceal haemorrhage. TIPSS was performed using Wallstents within a mean of 2.2 days of randomisation. Shunt function was assessed by direct pertngraphy at 1 and 6 months and yearly thereafter. VBL was performed using the Bard ligator within a mean of 2.8 days of randomisation and then weekly till eradication, then at 3 and 6 months and yearly thereafter. Results were analysed on an intention to treat basis. Results: Patients in both groups were well matched for age, sex, aetiology, severity of liver disease and the duration of follow up (T/PSS-6.3 (1.3) and VBL5 (0.6) months). Results are summarised below. TIPSS (N=lS) VBL (N=21) Success 16 (88.9%) 21 (100%) Variceal rebleedings 2 (11.1%) 11 (52%) Mortality 5 (27.7%) 5 (23.8%) Encephalopathy 4 (22.2%) 2 (9.5%) a - p
580 M E T A - A N A L Y S I S O F E N D O S C O P I C L I G A T I O N (EL) AND ENDOSCOPIC SCLEROTHERAPY (ES) IN THE PREVENTION OF G A S T R O I N T E S T I N A L R E B L E E D I N G IN P A T I E N T S W I T H CIRRHOSIS, B Bernard, D Lebrec*, P Mathurin, P Opolon, T Poynard. Service d'H~pato-Gastroent~rologie, H6pitul Piti~-Sal#tri~.re, 75651 Paris, *INSERM U-24, H6pital Beaujon. 92118 Clichy, France. Despite numerous randomized clinical trials (RCTs) which have compared EL and ES in patients with cirrhosis, no superiority has ben shown for either of these technics. The aim of this stud), was to compare the efficay of EL and ES in the prevention of recurrent bleeding, on survival rate and on the incidence of adverse events in patients with cirrhosis. Methods: An overview of RCTs comparing EL and ES in the prevention of recurrent bleeding in patients with cirrhosis was performed. RCTs including patients without cirrhosis, with hepatocellular carcinoma, or with end point assessed before 2 months of follow-up were excluded. Meta-analysis used Peto and Der Simonian methods in regular and cumulative analysis, with an estimate of methodological quality of RCTs and sensitivity analysis. End points were estimated according to the intention to treat method. Results: A total of 10 RCTs including 846 patients. 422 treated with EL and 424 with ES, with a mean follow-up of 9.5 ± 3.7 months, were identified. The mean percentage of patients free of rebleeding was 73 % in patients treated with EL and 54 % in patients treated by ES. This difference was significant by the Der Simonlan method (mean rate difference: 19 %, 95 % confidence interval (CI): 12-26 %. p<0.001) without heterogeneity. The mean percentage of patients free of adverse events was 77 % in patients treated with EL and 59 % in patients treated with ES, this difference was significant by the Der Simonian method (mean rate difference: 16 %, 95 % CI: 8-23 %, p<0.001) without heterogeneity. The mean survival rate was 74% in patients treated with EL and 64 % in patients treated with ES. This difference was significant by the Der Simonian method (mean rate difference: 7 %, 95 % CI: 1-12 %, p=0.02). The differences were also significant with the Peto method for the 3 evaluated end points, without heterogeneity. Sensitivity analysis concerning only the 3 RCTs published as articles also showed significant differences for the 3 end points with both methods. Conclusions: In patients with cirrhosis. EL was significantly more efficient than ES in the prevention of recurrent bleeding. In patients treated with EL, mean survival rate was significantly higher and adverse events were significantly less frequent than in those treated with ES.
AASLD
577 ENDOSCOPIC
SCLEROTHERAPY VERSUS ENDOSCOPIC VARICEAL LIGATION IN T H E M A N A G E M E N T OF BLEEDING E S O P H A G E A L VARICES: A PRELIMINARY REPORT OF A PROSPECTIVE R A N D O M I Z E D STUDY IN S C H I S T O S O M A L HEPATIC FIBROSIS. S. F~dlrv. M Omar. A. N o u i t M. AI-Gimmlm~ M- Serrv. M. Atria I. Moustafa. N. El- Beheiry. S. Hunter. Theodore Bilharz Research Institute, and Faculty o f Medicine, Cairo University, Cairo, Egypt. This study presents initial dam from a randomizes trial comparing endoscopic s d e m t h e m p y (ES) with endoscopic variexml ligation (EVL) for the definitive treatment o f vaficeal bleeding in patients with Schistosomal hepatic fibrosis. M e t h ~ l m Previously untreated patients with active or recent variceal bleedin8 were randomized at index endoscopic examination to either ES using 5% ethanolamine oleate, or EVL. Results: 51 Patients fulfilling the inclusion criteria were randomized, 26 (51%) for EVL, and 25 (49%) for ES. Groups were well matched for age, sex, grade o f varices and Child-Pugh classification. The mean follow-up period w a s 39+1- 0.7 weeks. 10 EVL and 12 ES patients were actively bleeding at index endoscopy. W e were able to control bleeding in 9110(90°,4) in EVL Stoup and 11/12(92",4) in ES Stoup. One patient died in each group due to failure to control active bleeding. Other results are: Eradicated Numher R ~ u r r e m Rt~t.-~a~t C o m p l l e ~ o m o f S~miom Vat'ices Bleedimz ES 24/24 4.7+/-0.9 7/24 (29%) 2/24 8/24 (33%) EVL 25/25 2.8+/-0.7 8/25 (32%) 1/25 1/25 (4%) p <0.05* >0.05 >0.05 <0.05* C e a d m i e a : Our preliminary results sngsest that E V L is as effective as ES in control o f actively bleeding variees. However, the number o f sessions needed for eradication o f vafices and complications are significantly lower in the EVL 8roup.
5 7 9 ~ p h y ~ i c ~ d o ~ p i c Wried Sand Ligatm {EW) Veins Sclerethempy (ES) For The Prev~ticu of Variceal Bleeding: An Interim Report of A Prespe~ve R~domized Controlled Trial in Schisto~mml PortalHypertension. K. ~ I. Waked. S. Sal~. M. SalLm1*. S. AbdeI-F~mh*. l)epartmm~ of Medicine, Liver Institute, Shebeen EI-Kom, and Ain Shams University School of M~lieim*, Cairo; EGYPT. The role o f p ~ c endoscopic therapy for the prevemi~ of ~rst variceal bleed in p o ~ ! hypemminn remains ~ i a l . EVL has become a tteatrt~ut option with lower complication rate than ES. Aim." The aim ofthis study is to evaluate EVL as a prephyiactic ~ for the pmvmtion of esophageal variceal bleeding in hish risk varices, and compare it to pmphyinctic ES in a ~ commlled trial. Patients aml Metlm(B" Fifty con~nth~ patients (35 males, Child clam A: 12, B:25, C:! 3), with sdhim3tmtml ~ h ~ (84% with c m ~ cirdmsis due to chronic viral hepatitis) and high risk varices (grade 3-4 with red wale nmrkmgs m d l~mocys~ slp~) who Imve not bled befere w~e ~ a t ~ y : 16 received EVL, 17 ES using 5%etham31areh~ oleate as ~ and 17 patients no therepy as central group. The groups were ~ for ~ , t~x m~d Clfild-Pugh seom EVL and E$ were & m e ~ r y 2 weeks till variceal obliteration or near obliteration to less than 1+, and f o l k ~ up e n d ~ o p y was dine monthly thereafter. Results: Two patiemts died o f hepatic failure and hepatoremal syndmree, one in EVL and m e in ES. 48 Patimts were followed for 12+-4 months (4-16). Varices were obliterated in 12/15 EVL pafim~ in 2.7+-1.8 sessimm, and in 14/16 ES patiems in 5.3+-1.8 semims (obliteratinn: us, number of sessinns p<0.01). Varices .w~,,.~l in 3115 EVL and 4/16 ES (m) 2-9 nmmh~ a~er obl~ration to 2+, and were treated with the init~ method. B l e e d ~ occurred in 3 ofthe comrel 1-6 months aRer madmnizstim (1 fatal, 2 controlled by ES), and 2 in the ES gump (both before o b l ~ , t ~ a t and o3utroUed by ES), (ns). Two in the EVL vs 10 in the ES had complicatinn$ (EVL: both ulcett, ES 6 ulcers, 4 mild~'ictures) (p-.-~0.01). C m d m i m : EVL is safe as a p ~ measure in high risk varines. Data so far su88wt that it is superior to ES mid no therepy, but not ~mdumve. More patients are being included, and a m u Itk~-~-ic trial is justifiecL
ABSTRACTS
251A
578 TIPSS VS VARICEAL BAND LIGATION IN THE SECONDARY
PREVENTION OF VARICEAL HAEMORRHAGE IN CIRRHOSIS: PRELIMINARY RESULTS OF A RANDOMISED, CONTROLLED STUDY. R.Jalan, E.H.Forrest, 'D.N.Redhead J.F.Dillon, K.l.Bzeizi, *N.D.C.Finlayson, *A.J.MacGilchnst, P.C.Hayes. *Centre for Liver and Digestive Disorders, Dept of Medicine and 'Radiology, Royal Infirmary, Edinburgh. Aims: The aim of this study was to compare transjngular intrahepatic pertosystemic stent-shunt (TIPSS) and variceal band ligation (VBL) in the secondary prevention of varieeal haemorrhage in patients with cirrhosis. Patients aad Methods: Thirty nine patients with cirrhosis were randomised to TIPSS (18 patients) or VBL (21 patients), 24 hours after successful control of variceal haemorrhage. TIPSS was performed using Wallstents within a mean of 2.2 days of randomisation. Shunt function was assessed by direct pertngraphy at 1 and 6 months and yearly thereafter. VBL was performed using the Bard ligator within a mean of 2.8 days of randomisation and then weekly till eradication, then at 3 and 6 months and yearly thereafter. Results were analysed on an intention to treat basis. Results: Patients in both groups were well matched for age, sex, aetiology, severity of liver disease and the duration of follow up (T/PSS-6.3 (1.3) and VBL5 (0.6) months). Results are summarised below. TIPSS (N=lS) VBL (N=21) Success 16 (88.9%) 21 (100%) Variceal rebleedings 2 (11.1%) 11 (52%) Mortality 5 (27.7%) 5 (23.8%) Encephalopathy 4 (22.2%) 2 (9.5%) a - p
580 M E T A - A N A L Y S I S O F E N D O S C O P I C L I G A T I O N (EL) AND ENDOSCOPIC SCLEROTHERAPY (ES) IN THE PREVENTION OF G A S T R O I N T E S T I N A L R E B L E E D I N G IN P A T I E N T S W I T H CIRRHOSIS, B Bernard, D Lebrec*, P Mathurin, P Opolon, T Poynard. Service d'H~pato-Gastroent~rologie, H6pitul Piti~-Sal#tri~.re, 75651 Paris, *INSERM U-24, H6pital Beaujon. 92118 Clichy, France. Despite numerous randomized clinical trials (RCTs) which have compared EL and ES in patients with cirrhosis, no superiority has ben shown for either of these technics. The aim of this stud), was to compare the efficay of EL and ES in the prevention of recurrent bleeding, on survival rate and on the incidence of adverse events in patients with cirrhosis. Methods: An overview of RCTs comparing EL and ES in the prevention of recurrent bleeding in patients with cirrhosis was performed. RCTs including patients without cirrhosis, with hepatocellular carcinoma, or with end point assessed before 2 months of follow-up were excluded. Meta-analysis used Peto and Der Simonian methods in regular and cumulative analysis, with an estimate of methodological quality of RCTs and sensitivity analysis. End points were estimated according to the intention to treat method. Results: A total of 10 RCTs including 846 patients. 422 treated with EL and 424 with ES, with a mean follow-up of 9.5 ± 3.7 months, were identified. The mean percentage of patients free of rebleeding was 73 % in patients treated with EL and 54 % in patients treated by ES. This difference was significant by the Der Simonlan method (mean rate difference: 19 %, 95 % confidence interval (CI): 12-26 %. p<0.001) without heterogeneity. The mean percentage of patients free of adverse events was 77 % in patients treated with EL and 59 % in patients treated with ES, this difference was significant by the Der Simonian method (mean rate difference: 16 %, 95 % CI: 8-23 %, p<0.001) without heterogeneity. The mean survival rate was 74% in patients treated with EL and 64 % in patients treated with ES. This difference was significant by the Der Simonian method (mean rate difference: 7 %, 95 % CI: 1-12 %, p=0.02). The differences were also significant with the Peto method for the 3 evaluated end points, without heterogeneity. Sensitivity analysis concerning only the 3 RCTs published as articles also showed significant differences for the 3 end points with both methods. Conclusions: In patients with cirrhosis. EL was significantly more efficient than ES in the prevention of recurrent bleeding. In patients treated with EL, mean survival rate was significantly higher and adverse events were significantly less frequent than in those treated with ES.