| |
RCT No. 1 |
RCT No. 2 |
|
Characteristic |
EST
(n=106) |
EPCS
(n=105) |
P
Value |
TIPS
(n=78) |
EPCS
(n=76) |
P
Value |
History
Age (yr):
Mean/median
Range
n≥70 yr |
47.8/45
23-75
7 |
49.8/47
28-82
9 |
0.21
0.61
0.61 |
49.0/47
30-84
1 |
49.1/48
31-73
2 |
0.89
0.62
0.35 |
| Male gender, n (%) |
81 (76) |
81 (78) |
0.87 |
56 (72) |
60 (79) |
0.65 |
Race, n (%):
Caucasian
Hispanic
Other |
53 (50)
50 (47)
3 (3) |
58 (55)
39 (37)
8 (8) |
0.09 |
33 (42)
39 (50)
6 (8) |
37 (49)
34 (45)
5 (7) |
|
Cause of cirrhosis, n (%):
Alcoholism alone
Hepatitis B or C alone
Alcoholism and hepatitis
Other |
58 (55)
10 (9)
30 (28)
8 (8) |
54 (51)
8 (8)
33 (31)
10 (9) |
0.73 |
29 (37)
4 (5)
44 (56)
1 (1) |
24 (32)
11 (14)
37 (49)
4 (5) |
0.083 |
Chronic alcoholism, n (%):
Years of alcoholism, mean (range)
Recent alcohol ingestion
≤7d, n (%) |
88 (83)
22 (4-59)
55 (62) |
87 (83)
25 (7-54)
57 (66) |
1.00
0.56
0.99 |
72 (97)
21.6 (5-45)
42 (58) |
61 (95)
21.6 (8-41)
34 (58) |
0.66
0.97
0.44 |
Past history, n (%):
Jaundice
Ascites
Portal-systemic encephalopathy
Delirium tremens in alcoholics |
61 (58)
70 (66)
20 (19)
23 (26) |
58 (55)
48 (46)
30 (29)
28 (31) |
0.78
0.004*
0.11
0.43 |
32 (41)
40 (51)
17 (22)
20 (28) |
42 (55)
53 (70)
18 (24)
21 (34) |
0.11
0.022*
0.85
0.45 |
Physical examination, n (%):
Jaundice
Ascites
Portal-systemic encephalopathy
Severe muscle wasting
(2+ or 3+ on 0-3+ scale)
Delirium tremens in alcoholics |
45 (42)
65 (61)
19 (18)
50 (47)
2 (2) |
38 (36)
54 (51)
19 (18)
67 (64)
2 (2) |
0.40
0.17
1.0
0.02*
1.00 |
34 (44)
37 (47)
19 (24)
40 (51)
1 (1) |
37 (49)
46 (61)
17 (22)
49 (64)
3 (5) |
0.63
0.11
0.8
0.11
0.33 |
| PSE Index – median
(interquartile range) |
0
(0-0.15) |
0
(0-0.15) |
0.46 |
0
(0-0.15) |
0
(0-0.16) |
0.44 |
Child risk class, n (%):
A (5 to 8 points)
B (9 to 11 points)
C (12 to 15 points) |
32 (30)
46 (43)
28 (26) |
26 (25)
49 (47)
30 (29) |
0.71 |
16 (21)
39 (50)
23 (29) |
15 (20)
37 (49)
24 (32) |
0.98 |
| Child risk class points, mean/median |
10.1/10 |
10.0/10 |
0.76 |
10.2/10 |
10.6/11 |
0.26 |
| |
EST |
EPCS |
TOTAL |
TIPS |
EPCS |
TOTAL |
| Referred for LT Evaluation, n (%) |
7 (6.6) |
6 (5.7) |
13 (6.2) |
8 (10.5) |
2 (2.6) |
10 (6.5) |
Diagnosis of LT Candidates, n (%):
Alcoholism
Hepatitis
Alcoholism and hepatitis
Cryptogenic
Autoimmune |
3 (2.8)
2 (1.9)
0
1 (0.9)
1 (0.9) |
1 (1.0)
0
3 (2.9)
2 (1.9)
0 |
4 (1.9)
2 (0.9)
3 (1.4)
3 (1.4)
1 (0.5) |
2 (2.6)
0
6 (7.7)
0
0 |
0
0
2 (2.6)
0
0 |
2 (1.3)
0
8 (5.2)
0
0 |
Results of LT Evaluation:
LT performed
LT approved but not done
LT denied |
4
2
1 |
0
1
5 |
4
3
6 |
4
0
4 |
0
0
2 |
4
0
6 |
Reason for denial:
Continued alcoholism
Continued drug abuse
Non-U.S. residence
Continued drug abuse and
non-U.S. residence |
0
0
1
0 |
3
1
0
1 |
3
1
1
1 |
2
0
0
2 |
2
0
0
0 |
4
0
0
2 |
Years after entry in RCT to final LT
Evaluation – mean (range) |
1.0
(0.04-2.35) |
2.7
(0.02-6.74) |
1.47
(0.02-6.74) |
1.5
(0.75-1.5) |
3.0
(2.0-3.5) |
2.25
(0.75-3.5) |
| Approved for LT, n (%) |
6 (5.6) |
1 (1.0) |
7 (3.3) |
4 (5.1) |
0 |
4 (2.6) |
| Years on waiting list – mean (range) |
0.162
(0-0.59) |
8.96
(n=1) |
|
0.38
(0.5-0.7) |
0 |
|
| Died on waiting list (time) |
0 |
0 |
0 |
0 |
0 |
0 |
Survival after LT (n=)
mean (range), yrs |
0.204
(0.001-0.805) |
N/A |
0.204
(0.001-0.805) |
0.4
(0.2-0.6) |
N/A |
0.4
(0.2-0.6) |
Survival after evaluation, no LT
mean (range), yrs (n=) |
0.237
(0.047-0.586) |
6.027
(0.017-12.73) |
4.097
(0.017-12.73) |
0.6
(0.2-0.8) |
-- |
0.6
(0.2-0.8) |
Survival since entry
mean (range), yrs (n=) |
1.266
(0.088-2.357) |
8.720
(0.033-13.140) |
4.706
(0.033-13.140) |
1.9
(0.75-1.75) |
-- |
1.9
(0.75-1.15) |
| MELD at LT evaluation – mean (range) |
21.3 (7-39) |
20.2 (7-36) |
20.8 (7-39) |
24 (20-30) |
26 (22-32) |
25 (20-32) |
| MELD at evaluation of LT patients
mean (range) |
20.8 (17-27) |
-- |
20.8 (17-27) |
24 (20-28) |
-- |
24 (20-28) |
Child class at LT evaluation:
A
B
C |
0
1
6 |
0
4
2 |
TOTAL
0
5
8 |
0
0
8 |
0
0
2 |
TOTAL
0
0
10 |
*Statistically significant difference