Effectiveness of a new approach to minimally invasive surgery in palliative treatment of patients with distal malignant biliary obstruction

Table 1 General characteristics of study participants, n (%)

Indicator	Total, n = 134	Study group				Pvalue
		EIBJD, n = 29	ERBS, n = 25	IETBD, n = 19	PTBD, n = 65
Age in yr, mean ± SD	64.1 ± 11.6	65.8 ± 10.1	61.9 ± 12.9	62.2 ± 13.0	66.0 ± 10.4	0.296
Male/female	69/65	19/15	17/15	14/16	19/19	0.894
Duration of jaundice in d, mean ± SD	15.0 ± 2.0	14.7 ± 1.5	15.5 ± 2.0	14.9 ± 2.6	14.3 ± 1.1	0.250
Total serum bilirubin in mg/dL, mean ± SD	11.3 ± 4.6	12.4 ± 4.5	12.3 ± 4.2	10.1 ± 5.3	10.5 ± 4.2	0.092
Cholangitis before the procedure	19 (14.2)	6 (17.6)	4 (12.5)	4 (13.3)	5 (13.2)	0.928
T stage
T2	6 (4.6)	1 (2.9)	1 (3.1)	2 (6.7)	2 (5.3)	0.985
T3	78 (58.2)	19 (55.9)	19 (59.4)	18 (60.0)	22 (57.9)
T4	50 (37.3)	14 (41.2)	12 (37.5)	10 (33.3)	14 (36.8)
N stage
N0	8 (6.7)	3 (8.8)	2 (6.3)	3 (10.0)	1 (2.6)	0.922
N1	97 (72.4)	24 (70.6)	24 (75.0)	19 (63.3)	30 (78.9)
N2	11 (8.2)	3 (8.8)	2 (6.3)	4 (13.3)	2 (5.3)
Nx	17 (12.7)	4 (11.8)	4 (12.5)	4 (13.3)	5 (13.2)
М stage
М0	64 (47.8)	14(41.2)	18 (56.3)	16 (53.3)	16 (42.1)	0.858
М1	53 (39.6)	15 (44.1)	11 (34.4)	10 (33.3)	17 (44.7)
Мх	17 (12.7)	5 (14.7)	3 (9.4)	4 (13.3)	5 (13.2)
Grade
ІІВ	4 (3.0)	1 (2.9)	1 (3.1)	2 (6.7)	0 (0.0)	0.760
ІІІ	47 (35.1)	12 (35.3)	13 (40.6)	10 (33.3)	12 (31.6)
ІV	83 (61.9)	21 (61.8)	18 (56.3)	18 (60.0)	26 (68.4)
Tumour etiology
Pancreatic cancer	92 (68.7)	23 (67.6)	23 (71.9)	19 (63.3)	27 (71.1)	0.757
Cholangiocarcinoma	25 (18.7)	7 (20.6)	5 (15.6)	7 (23.3)	6 (15.8)
Ampullary cancer	14 (10.4)	2 (5.9)	3 (9.4)	4 (13.3)	5 (13.2)
Metastatic nodes	3 (2.2)	2 (5.9)	1 (3.1)	0 (0.0)	0 (0.0)

ERBS: Endoscopic retrograde biliary stenting; IEBJD: Internal-external biliary-jejunal drainage; IETBD: Internal-external transpapillary biliary drainage; PTBD: Percutaneous transhepatic biliary drainage.

Table 2 Frequency of minor postoperative complications in study groups, n (%)

Complication	Study group				Pvalue
	EIBJD, n = 34	ЕRBS, n = 32	IETBD, n = 30	PTBD, n = 38
Pain in the drainage area	6 (17.6)	5 (15.6)	7 (23.3)	7 (18.4)	0.885
Hyperthermia	3 (8.8)	-	2 (6.7)	3 (7,9)	0.423
Bile leakage	1 (2.9)	2 (6.3)	1 (3.3)	2 (5.3)	0.903
Bleeding	3 (8.8)	-	3 (10,0)	4 (10.5)	0.325
Subcapsular biloma	1 (2.9)	3 (9.4)	1 (3.3)	1 (2.6)	0.498
Shingle pain	1 (2.9)	-	1 (3.3)	2 (5.3)	0.642
Total	1 (2.9)	3 (9.4)	1 (3.3)	-	0.223

ERBS: Endoscopic retrograde biliary stenting; IEBJD: Internal-external biliary-jejunal drainage; IETBD: Internal-external transpapillary biliary drainage; PTBD: Percutaneous transhepatic biliary drainage.

Table 3 Frequency and types of significant postoperative complications in study groups, n (%)

Indicator	Study group				Pvalue
	EIBJD, n = 34	ЕRBS, n = 32	IETBD, n = 30	PTBD, n = 38
Patients with complications	5 (14.7)	10 (31.3)	13 (43.3)	8 (21.1)	0.053
Number of complications in one patient
No	29 (85.3)	22 (68.8)	17 (56.7)	30 (78.9)	0.072
One	5 (14.7)	7 (21.9)	10 (33.3)	8 (21.1)
Two	0 (0.0)	3 (9.4)	3 (10.0)	0 (0.0)
Type of complication
Cholangitis	3 (8.8)	8 (25.0)	10 (33.3)	9 (13.2)	0.052
Pancreatitis
No	32 (94.1)	28 (87.5)	27 (90.0)	38 (100)	0.121
Mild	2 (5.9)	2 (6.3)	3 (10.0)	0 (0.0)
Moderately severe	0 (0.0)	2 (6.3)	0 (0.0)	0 (0.0)
Cholecystitis	0 (0.0)	0 (0.0)	1 (3.3)	3 (7.9)	0.157
Liver abscess	0 (0.0)	1 (3.1)	2 (6.7)	0 (0.0)	0.217

ERBS: Endoscopic retrograde biliary stenting; IEBJD: Internal-external biliary-jejunal drainage; IETBD: Internal-external transpapillary biliary drainage; PTBD: Percutaneous transhepatic biliary drainage.

Table 4 Features of cholangitis in study groups

Indicator	Study group
	EIBJD, n = 34	ЕRBS, n = 32	IETBD, n = 30	PTBD, n = 38
The time period from the procedure until the cholangitis onset, d	106.7 ± 38.4a	75.1 ± 14.9b	35.3 ± 9.9b	44.5 ± 9.9b
Cholangitis duration, d	4.7 ± 0.3a	9.9 ± 0.5b	7.7 ± 0.6b	5.3 ± 0.2a

^aDifferent letters indicate significant differences between study groups (Tukey post-hoc test with Bonferroni correction, P < 0.05.

^bDifferent letters indicate significant differences between study groups (Tukey post-hoc test with Bonferroni correction, P < 0.05). ERBS: Endoscopic retrograde biliary stenting; IEBJD: Internal-external biliary-jejunal drainage; IETBD: Internal-external transpapillary biliary drainage; PTBD: Percutaneous transhepatic biliary drainage.

Table 5 Hazard ratios and 95% confidence intervals for the mortality in patients who underwent internal-external biliary-jejunal drainage as compared to other techniques

Observation period in mo	PTBD	IETBD	ERBS
3	0.39; 0.19-0.82, Р = 0.018	0.31; 0.14-0.69, Р = 0.005	0.75; 0.31-1.76, Р = 0.438
6	0.49; 0.28-0.87, Р = 0.011	0.34; 0.18-0.66, Р < 0.001	0.96; 0.56-1.69, Р = 0.982
9	0.36; 0.22-0.60, Р < 0.001	0.26; 0.14-0.49, Р < 0.001	0.78; 0.49-1.22, Р = 0.232
12	0.39; 0.24-0.64, Р < 0.001	0.26; 0.14-0.48, Р < 0.001	0.86; 0.56- 1.32, Р = 0.507
15	0.38; 0.23-0.62, Р < 0.001	0.30; 0.17-0.54, Р < 0.001	0.77; 0.51-1.16, Р = 0.078

ERBS: Endoscopic retrograde biliary stenting; IETBD: Internal-external transpapillary biliary drainage; PTBD: Percutaneous transhepatic biliary drainage.