Santambrogio R, Opocher E, Costa M, Bruno S, Ceretti AP, Spina GP. Natural history of a randomized trial comparing distal spleno-renal shunt with endoscopic sclerotherapy in the prevention of variceal rebleeding: A lesson from the past. World J Gastroenterol 2006; 12(39): 6331-6338 [PMID: 17072957 DOI: 10.3748/wjg.v12.i39.6331]
Corresponding Author of This Article
Dr Roberto Santambrogio, via N Battaglia 34, Milano 20127, Italy. rsantambrogio@mclink.it
Article-Type of This Article
Clinical Research
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World J Gastroenterol. Oct 21, 2006; 12(39): 6331-6338 Published online Oct 21, 2006. doi: 10.3748/wjg.v12.i39.6331
Table 1 Characteristics of patients enrolled in the RCT
Characteristic
DSRS (n = 40)
ES (n = 40)
P
Age (yr)
49.4 ± 9.9
53.8 ± 8.4
0.027
Sex: M/F
27/13
33/7
0.121
Etiology: alcoholic/ non alcoholic
14/26
26/14
0.0073
Child’s class: A/B
19/21
11/29
0.053
Prothrombin time: > 80/80-50/< 50
5%/82%/13%
13%/62%/25%
0.058
Bilirubin (μmol/L): < 20.5/20.5-51.3/> 51.3
62%/38%/0%
41%/46%/13%
0.0269
Albumin (g/L): > 30/30-25/< 25
95%/5%/0%
83%/17%/0%
0.077
Portal perfusion: degree I/II/III
45%/45%/10%
42%/27%/31%
0.09
Previous bleeding (n)
2.3 ± 1.5
1.6 ± 0.09
0.022
Blood unit (n)
5.5 ± 5
4.3 ± 4.2
0.25
Interval between bleeding and treatments (mo)
3.5 ± 2.5
2.8 ± 3.2
0.32
Previous encephalopathy episodes (n)
10
7
0.41
Easily controlled preoperative ascites
5
11
0.09
Table 2 Comparison of the results of TMT, cancelling A's test and EEG. A’s test refers to the number of A's the patients has omitted to cancel in the test
Preoperative
Long-term follow-up
P
TMT (s)
DSRS
55.3 ± 24.9
55.4 ± 27.9
NS
ES
60.1 ± 19.7
66.1 ± 40.1
NS
A's test
DSRS
4.9 ± 3.8
2.6 ± 2.5
< 0.05
ES
5.5 ± 4.3
3.7 ± 3.4
< 0.05
EEG (% abnormal)
DSRS
20%
36%
< 0.05
ES
16%
21%
NS
Table 3 Causes of death of patients submitted to DSRS (n = 26) or ES (n = 31)
Causes of death
DSRS
ES
Digestive bleeding
1 (4%)
5 (16%)
Liver failure
6 (23%)
11 (36%)
Hepatocellular carcinoma
13 (50%)
10 (32%)
Other causes
6 (23%)
5 (16%)
Table 4 Results (actuarial survival curves and log-rank test) of the univariate analysis of some variables calculated during different interval of follow-up
Variables
P (at 5 yr)
P (at 10 yr)
P (total follow-up)
Type of treatment (DSRS vs ES)
0.0385
0.1415
0.1168
Sex
0.2186
0.3374
0.1943
Child’s score (A vs B)
0.0358
0.2533
0.1594
Etiology of cirrhosis (non-alcohol vs alcohol)
0.2891
0.0749
0.0438
Portal perfusion
0.2671
0.3579
0.3158
Preop. Ascites
0.3339
0.9022
0.9254
Preop. encephalopathy
0.6544
0.9857
0.8732
Preop. Varices
0.6513
0.4552
0.3858
No. of previous bleeding
0.1724
0.2739
0.1308
Preop. Bilirubin
0.2944
0.3358
0.0604
Preop. GOT
0.4504
0.2659
0.2553
Preop. Prothrombin time
0.2835
0.5629
0.4815
Preop. Albumin
0.7440
0.2133
0.1823
Age (< 53 yr)
0.1419
0.0431
0.0438
Postop. Rebleeding
0.1715
0.1168
0.0819
Table 5 2-yr survival and rebleeding rate in randomized controlled trials comparing DSRS with ES
Citation: Santambrogio R, Opocher E, Costa M, Bruno S, Ceretti AP, Spina GP. Natural history of a randomized trial comparing distal spleno-renal shunt with endoscopic sclerotherapy in the prevention of variceal rebleeding: A lesson from the past. World J Gastroenterol 2006; 12(39): 6331-6338