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

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

NS: Not significant.

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

Preop: Preoperative; Postop: Postoperative.

Table 5 2-yr survival and rebleeding rate in randomized controlled trials comparing DSRS with ES

	Warren[5]	Terés[7]	Rikkers[6]	Our data
2-yr survival rate
after DSRS	59%a	71%	65%	95%
2-yr survival rate
after ES	84%a	68%	61%	85%
Child's C patients	43%	0	33%	0
Interval between bleeding
and treatment (d)	> 3-5	10-15	NR	901
Rebleeding rate after
DSRS	3%a	14%a	19%a	2.5%a
Rebleeding rate after
ES	53%a	37%a	57%a	35%a
Variceal eradication
rate	NR	46%	63%	90%
Failure to salvage
rebleeders	17%	33%	47%	14%
Shunt for ES failure	31%	6%	7%	5%
Global mortality rate
due to rebleeding	3%	14%	27%	16%
Global mortality rate
due to other causes	13%	16%	13%	17%

NR = Not reported; ¹mean value;

^aP < 0.05 vs ES.