Patients’ Demographics:
The study comprised 130 patients with suspected to choledocholithiasis who underwent Liver function test, Trans-abdominal USG and MRCP. Age distribution in the present study was found to be from 25 yrs to 71 yrs, the mean age of patients was 49.27 ± 10.60 years, out of 130 patients, 89 patients were female and 41 patients were male, the ratio of male: female was 1:2.08.
Table 1:Distribution of participants according to gender& present of cbd stone (n=130)
|
SEX
|
CBD STONE FOUND (+)
No. (%)
|
CBD STONE NOT FOUND (-)
No. (%)
|
TOTAL
No. (%)
|
MALE
|
37 (28.46%)
|
04(3.08%)
|
41(31.54%)
|
FEMALE
|
77(59.23%)
|
12(9.23%)
|
89(68.46%)
|
TOTAL
|
114(87.69%)
|
16(12.31%)
|
130 (100%)
|
Distribution of participants according to age (n=130)
|
Age group
|
Male, n(%)
|
Female,n(%)
|
Total ,n(%)
|
21-30
|
03(02.30)
|
09(06.92%)
|
12(09.0%)
|
31-40
|
04(03.08)
|
10(07.69%)
|
14(11.0%)
|
41-50
|
16(12.30)
|
35(26.92%)
|
51(38.9%)
|
51-60
|
10(07.70)
|
21(16.16%)
|
31(24.0%)
|
>60
|
08(06.16)
|
14(10.77%)
|
22(17.1%)
|
TOTAL
|
41(31.54%)
|
89(68.46%)
|
130(100%)
|
Table1, shows common bile duct stones are more common in female than male and male:female ratio is 1:2.08.This table reveals age specific distribution of choledocholithiasis among study participants,female were more than male in each group of age and the disease is common in 41-50 age group. The mean age is 49.27 ± 10.60 years(range 25-71 Yrs)
Clinical profile and Laboratory investigation of patients:
TABLE 2: DISTRIBUTION OF PARTICIPANTS AS PER TOTAL BILIRUBIN LEVEL ANDCBD STONES FINDINGS.
|
Age gr
|
Gender
|
<2.41 mg/dl
No. (%)
|
2.41-4.6 mg/dl
No. (%)
|
>4.6 mg/dl
No. (%)
|
Total
No. (%)
|
CBD stone found, n (%)
|
21-30
|
Male
|
1(0.77%)
|
3(2.31%)
|
1(0.77%)
|
5(3.85%)
|
3(2.63%)
|
Female
|
5(3.84%)
|
-
|
4(3.08%)
|
9(6.92%)
|
7(6.14%)
|
31-40
|
Male
|
2(1.54%)
|
-
|
-
|
2(1.54%)
|
3(2.63%)
|
Female
|
4(3.08%)
|
8(6.15%)
|
2(1.54%)
|
14(10.77%)
|
10(8.77%)
|
41-50
|
Male
|
3(2.31%)
|
8(6.15%)
|
7(5.38%)
|
18(13.84%)
|
16(14.04%)
|
Female
|
8(6.15%)
|
18(13.85%)
|
4(3.08%)
|
30(23.08%)
|
29(25.44%)
|
51-60
|
Male
|
-
|
6(4.62)
|
4(3.08%)
|
10(7.70%)
|
8(7.02%)
|
Female
|
5(3.85%)
|
7(5.38%)
|
8(6.15%)
|
20(15.38%)
|
19(16.67%)
|
>60
|
Male
|
-
|
1(0.77%)
|
5(3.64%)
|
6(4.61%)
|
6(5.26%)
|
Female
|
2(1.54%)
|
3(2.31%)
|
11(8.46%)
|
16(12.31%)
|
13(11.40%)
|
Total
|
|
30(23.08%)
|
54(41.54%)
|
46(35.58%)
|
130(100%)
|
114(100%)
|
DISTRIBUTION OF PARTICIPANTS AS PER SERUM ALKALINE PHOSPHATASE LEVEL WITH CBD STONE FINDINGS.
|
Age gr.
|
Gender
|
<235 IU/L n,(%)
|
>=235 IU/L n,(%)
|
Total, n (%)
|
CBDst0ne found, n (%)
|
21-30
|
Male
|
2(1.54%)
|
1(0.77%)
|
3(2.31%)
|
3(2.63%)
|
Female
|
3(2.31%)
|
6(4.62%)
|
9(6.92%)
|
7(6.14%)
|
31-40
|
Male
|
2(1.54%)
|
5(3.85%)
|
7(5.39%)
|
3(2.63%)
|
Female
|
2(1.54%)
|
9(6.92%)
|
11(8.46%)
|
10(8.77%)
|
41-50
|
Male
|
3(2.31%)
|
8(6.15%)
|
11(8.46%)
|
16(14.04%)
|
Female
|
12(9.23%)
|
24(18.46%)
|
36(27.69%)
|
29(25.44%)
|
51-60
|
Male
|
2(1.54%)
|
8(6.15%)
|
10(7.69%)
|
8(7.02%)
|
Female
|
5(3.84%)
|
16(12.31%)
|
21(16.16%)
|
19(16.67%)
|
>60
|
Male
|
2(1.54%)
|
6(4.62%)
|
8(6.15%)
|
6(5.26%)
|
Female
|
1(0.76%)
|
13(10.00%)
|
14(10.77%)
|
13(11.40%)
|
Total
|
|
34(26.15%)
|
96(73.85%)
|
130(100%)
|
114(100%)
|
Table2 shows mean total bilirubin level is 3.50 ±1.36 mg/dl ( range 1.02-7.04). Serum total bilirubin level was raised above 1.21mg/dl except one case bilirubin is 1.02 mg/dl.Mean Alkaline Phosphatase level is 381.56 ± 219.684 IU/L(range 156.04 -1304.15) in this study. 96 out of 130 serum alkaline phasphatase level were >235IU/L
.
TABLE 3:DISTRIBUTION OF PARTICIPANTS AS PER CBD STONES DETECTED BY USG (TRANSABDOMINAL) , MRCP and CBD STONES DETECTED DURING INTRA-OPERATIVE PERIOD.
SEX
|
USG
|
TOTAL
No. (%)
|
STONE DETECTED IN CBD
No. (%)
|
STONE NOT DETECTED IN CBD
No. (%)
|
MALE
|
18(13.85%)
|
23(17.69%)
|
41(31.54%)
|
FEMALE
|
39(30.00%)
|
50(38.15%)
|
89(68.46%)
|
TOTAL
|
57(43.85%)
|
73(56.15%)
|
130(100%)
|
Gender
|
MRCP
|
CBD stone present n.(%)
|
CBD stone absent n.(%)
|
Total n. (%)
|
Male
|
36(27.69%)
|
5(3.85%)
|
41(31.54%)
|
Female
|
76(58.46%)
|
13(10.00%)
|
89(68.46%)
|
Total
|
112(86.15%)
|
18(13.85%)
|
130(100%)
|
Gender
|
Intra-operative
|
CBD stone present,n(%)
|
CBD stone absent,n(%)
|
Total
|
Male
|
36(27.69%)
|
05(3.85%)
|
41(31.54%)
|
Female
|
78(60.00%)
|
11(8.46%)
|
89(68.46%)
|
Total
|
114(87.69%)
|
16(12.31%)
|
130(100%)
|
Table 3 shows, trans-abdominal USG detected only 43.85% CBS stones..112 out of 130(86.15%) CBD stones detected by MRCP. 114 out of 130 (87.69%) CBD stones detected during Intra-operative period.
TABLE 4 : DISTRIBUTION OF PARTICIPANTS AS PER CBD DAIMETER.[n=130] and AS PER POSITION OF CBD STONES IN DIFFERENT STAGES OF EVALUATION
Different stages of evaluation
|
CBD diameter
|
Total No.(%)
|
<7mm
No. (%)
|
≥7mm
No. (%)
|
CBD Diameter on USG
|
41(31.54%)
|
89(68.46%)
|
130(100%)
|
CBD Diameter on MRCP
|
6(4.61%)
|
124(95.39%)
|
130(100%)
|
CBD Diameter Intra-Operative
|
7(5.39%)
|
123(94.61%)
|
130(100%)
|
FINDINGS at different stages
|
Overall (n=130)
|
Subgroups
|
Number of patient stone +
No. (%)
|
Proximal CBD
No. (%)
|
Distal CBD
No. (%)
|
Ampullary
No. (%)
|
Position of stone at CBD in USG
|
57(43.85%)
|
2(1.54%)
|
55(42.31%)
|
-
|
Position of stone at CBD in MRCP
|
112(86.15%)
|
3(2.31%)
|
98(75.38%)
|
11(8.46%)
|
Position of stone at CBD in Inrta-operative.
|
114(87.69%)
|
2(1.54%)
|
100(76.92%)
|
12(9.23%)
|
Table 4 shows,choledocholithiasis CBD were dilated due to obstruction. Distal CBD stones are most common and Ampullary stones detection by MRCP is significant.
FIGURE 1: USG AND MRCP vs intra-operative finding.
TABLE 5: USG(TRANS-ABDOMINAL) & MRCP vs INTRA-OPERATIVE( STANDARD)
|
IMAGING TESTS OF CHOLEDOCHOLITHIASIS
|
INTRAOPERATIVE FINDINGS OF CHOLEDOCHOLITHIASIS
|
PRESENT
No. (%)
|
ABSENT
No. (%)
|
TOTAL
No. (%)
|
USG
|
PRESENT
|
56(43.08%)
|
1(0.77%)
|
57(43.85%)
|
ABSENT
|
58(44.61%)
|
15(11.54%)
|
73(56.15%)
|
TOTAL
|
114(87.69%)
|
16(12.31%)
|
130(100%)
|
MRCP
|
PRESENT
|
110(84.61%)
|
2(1.54%)
|
112(86.15%)
|
ABSENT
|
4(3.08%)
|
14(10.77%)
|
18(13.85%)
|
TOTAL
|
114(87.69%)
|
16(12.31%)
|
130(100%)
|
Table 5 shows, CBD stonesdetection by MRCP (84.61%) was very high almost near to gold standard (87.69%) but by USG it was low only 43.08%.
TABLE 6:DISTRIBUTION OF STUDY POPULATION ACCORDING TO DIFFERENT OPERATIVE PROCEDURES.
|
OPERATIVE PROCEDURES
|
Number of cases (n=130)
|
LAP GB + CBD EXPLORATION
|
22
|
OPEN GB + CBD EXPLORATION
|
82
|
CBD EXPLORATION
|
6
|
OPEN GB+CBD PALPATION +EXPLORATION
|
4
|
OPEN GB+CBD PALPATION
|
16
|
Distribution of participants as per trans-abdominal USG(test test) vs Intra-operative findings (gold standard= truth). [130].
|
USG FINDINGS
|
INTRA-OPERATIVE
|
TOTAL NO.
(%)
|
X2,
df,
P value
|
CBD STONE PRESENT,NO,
.(%)
|
CBD STONE ABSENT, NO. (%)
|
STONE PRESENT
|
56(43.08%)
|
1(0.77%)
|
57(43.85%)
|
10.47,
1,
P value =0.001
|
STONE ABSENT
|
58(44.61%)
|
15(11.54%)
|
73(56.15%)
|
TOTAL
|
114(87.69%)
|
16(12.31%)
|
130(100%)
|
|
Table 6 shows, that results of the test test ie,USG significantly differ from the truth ie,intra-operative findings. It means that the test USG didn’t seem to be suitable for diagnosing the disease in question.
The sensitivity of USG was: =49.12%,
Specificity was: =93.75%,
Positive predictive value was; =98.25%,
And negative predictive value was: =20.55%.
The sensitivity of the test USG reflected that the test seemed to be weak in detecting the disease in question ie, too many false negative would be produced by the test. For an emergency surgical problem like choledocholithiasis it couldn’t be the ‘investigation of choice’. As there is very effective treatment is available for choledocholithiasis we are not ready to tolerate so much false negativity of the diagnostic which missed so many cases.
TABLE 7: MRCP VS INTRA-OPERATIVE (STANDARD)
MRCP findings
|
Intra-operative findings
|
Total
No. (%)
|
X2,
df,
P value
|
STONE PRESENT
No. (%)
|
STONE ABSENT
No. (%)
|
STONE PRESENT
|
110(84.61%)
|
2(1.54%)
|
112(86.15%)
|
0.6666,
1,
P = 0.0000*
|
STONE ABSENT
|
4(3.08%)
|
14(10.77%)
|
18(13.85%)
|
TOTAL
|
114(87.69%)
|
16(12.31%)
|
130(100%)
|
_
|
Table 7 shows that result of the test test ie, MRCP not significantly differ from the truth ie, intra-operative findings. It mean that the test MRCP seemed to be suitable for diagnosing the disease.
The sensitivity of MRCP was:(110/114)*100=96.491%,
Specificity was:(14/16)*100 =87.500%,
Positive predictive value was:(110/112)*100 =98.214%,
And negative predictive value was;(14/18)*100 =77.777%.
The sensitivity of the test MRCP reflected that the test seemed to be strong in detecting the disease ie, very low false negative would be produced by the test. For an emergency surgical problem like choledocholithiasis it should be the ‘investigation of choice’.
TABLE 8: Distribution of participants as per USG (test test) vs MRCP (test test ). [N=130].
USG report regarding CBD stones
|
MRCP report regarding CBD stones
|
Total No. (%)
|
McNemar x2,
DF,
P value
|
Positive (+), (%)
|
Negative(-), (%)
|
Positive (+)
|
56 (98.25%)
|
01 (1.75 %)
|
57 (100%)
|
53.070,
1,
>0.05
|
Negative (-)
|
56 (76.71 %)
|
17 (23.29 %)
|
73 (100%)
|
Total
|
112 (86.15%)
|
18 (13.85%)
|
130 (100%)
|
_
|
McNemar’s Chi-Square Test (paired) X2 = 53.070
DF = 1 ,P Value >0.05
Table 8 shows for comparison of diagnostic accuracy of the test test McNemar also called paired Chi-Square test was carried out considering the discordant values of cell b (false positive) & c (false negative) .
McNemar x2 = (b-c)2/(b+c). It was revealed that the accuracy of the two test wasn’t comparable rather they showed a statistically significant difference .It mean that the test with lower accuracy, shouldn’t be the ‘investigation of choice’.
Though, the MRCP is costly and complex in terms of applicability, but it should be the ‘investigation of choice’ unless otherwise indicated.