Outcomes of endoscopic sphincterotomy vs open choledochotomy for common bile duct stones

doi:10.3748/wjg.v25.i4.485

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Retrospective Study

World J Gastroenterol. Jan 28, 2019; 25(4): 485-497
Published online Jan 28, 2019. doi: 10.3748/wjg.v25.i4.485

Table 1 Baseline clinical characteristics of patients with common bile duct stones

Characteristic		Before matching			After matching
Characteristic		EST (n = 168)	OCT (n = 134)	P-value	EST (n = 88)	OCT (n = 88)	P-value
Age at enrollment, mean ± SD, yr		57.1 ± 14.8	57.5 ± 13.5	0.799	58.6 ± 14.7	58.4 ± 13.8	0.920
Sex, male/female, n		73/95	65/69	0.381	38/50	40/48	0.762
Bile duct diameter, mean ± SD, mm		10.9 ± 4.4	14.4 ± 5.8	< 0.001^b	12.4 ± 5.1	12.7 ± 4.2	0.663
Stone number, multiple/single, n		63/105	57/77	0.374	33/55	33/55	1.000
Maximum stone size, n (%)		1.0 ± 0.5	1.4 ± 0.7	< 0.001^b	1.2 ± 0.5	1.2 ± 0.6	0.484
Cholangitis on admission, n (%)		42 (25.0)	34 (25.4)	0.941	23 (26.1)	22 (25.0)	0.863
	Mild	28 (16.6)	28 (20.9)	0.133	13 (14.7)	18 (20.5)	0.139
	Moderate	7 (4.2)	5 (3.7)		5 (5.7)	3 (3.4)
	Severe	7 (4.2)	1 (0.8)		5 (5.7)	1 (1.1)
Previous gastrectomy, n (%)
	Billroth-I	0	7 (5.2)	0.006^b	-	-	-
	Billroth-II	0	9 (6.7)	0.005^b	-	-	-
Hypertension, n (%)		19 (11.3)	15 (11.2)	0.951	12 (13.6)	11 (12.5)	0.823
Diabetes mellitus, n (%)		11 (6.5)	7 (5.2)	0.629	7 (7.9)	6 (6.8)	0.773
Charlson comorbidity index, mean ± SD		0.7 ± 0.9	0.8 ± 1.0	0.334	0.8 ± 1.0	0.8 ± 0.9	0.807
Prior cholecystectomy, n (%)		18 (10.7)	17 (12.7)	0.595	12 (13.6)	9 (10.2)	0.485
Gallbladder with stones in situ, n (%)		150 (89.3)	117 (87.3)	0.595	76 (86.4)	79 (89.8)	0.485
Preoperative biochemical parameters, median (IQR)
	T-Bil, μmol/L	18.9 (10.8-47.2)	16.6 (9.5-39.1)	0.164	16.9 (10.3-43.5)	15.4 (9.1-40.3)	0.432
	ALT, U/L	81.5 (28.8-162.0)	40.5 (18.0-96.3)	< 0.001^b	56.0 (22.3-101.8)	36.5 (17.5-98.3)	0.264
	AST, U/L	47.0 (22.8-91.0)	32.0 (20.0-62.2)	0.053	37.0 (21.8-79.3)	29.0 (19.0-60.0)	0.259
	γ-GTP, U/L	162.5 (82.0-266.3)	147.0 (67.5-264.8)	0.446	131.5 (74.8-296.0)	133.0 (64.8-226.8)	0.380
	ALP, U/L	234.0 (76.0-475.5)	126.5 (65.5-313.5)	0.049^a	160.5 (66.3-351.5)	121.0 (65.8-303.3)	0.642
Follow up period, median (IQR), yr		6.3 (5.4-7.3)	6.2 (5.1-7.8)	0.732	6.3 (5.2-7.3)	6.9 (5.4-8.2)	0.168

^aP < 0.05.

^bP < 0.01.

EST: Endoscopic sphincterotomy; OCT: Open choledochotomy; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; T-Bil: Total bilirubin; ALP: Alkaline phosphatase; γ-GTP: γ-glutamyl transferase; SD: Standard deviation; IQR: Interquartile range.

Table 2 Safety profile and procedure-related short-term outcomes of endoscopic sphincterotomy and open choledochotomy

Short-term outcome measure		Before matching			After matching
Short-term outcome measure		EST (n = 168)	OCT (n = 134)	P-value	EST (n = 88)	OCT (n = 88)	P-value
Time to biliary obstruction relief, mean ± SD, d		2.8 ± 1.6	7.6 ± 4.3	< 0.001^b	2.8 ± 1.6	7.1 ± 3.7	< 0.001^b
Anesthetic duration, median (IQR), min		174 (150-215)	222 (181.8-269.8)	< 0.001^b	175 (149-217.8)	207 (170-252.5)	< 0.001^b
¹Procedure time, median (IQR), min		105 (84-141.2)	150 (115.8-180)	< 0.001^b	110 (85-151.3)	145 (112-180)	< 0.001^b
No. of complete stone clearance sessions, n (%)				< 0.032^a			0.009^b
	1	149 (88.7)	128 (95.5)		77 (87.5)	86 (97.7)
	≥ 2	19 (11.3)	²6 (4.5)		11 (12.5)	²2 (2.3)
Methods of cholecystectomy, n (%)				< 0.001^b			< 0.001^b
	OC	7 (4.2)	117 (87.3)		1 (1.1)	79 (89.8)
	LC	143 (85.1)	0		75 (85.2)	0
³Hospital stay, median (IQR), d		6 (5-9)	9 (8-12)	< 0.001^b	6.5 (5-9.3)	9 (8-12)	< 0.001^b
Hospitalization cost, median (IQR), ×10³ yuan		17.9 (15.4-21.8)	17.6 (13.7-21.2)	0.083	18.0 (15.9-21.4)	17.8 (14.3-21.5)	0.115
Complications, n (%)		19 (11.3)	19 (14.2)	0.455	9 (10.2)	9 (10.2)	1.000
	Bleeding	3 (1.8)	7 (5.2)	0.097	1 (1.1)	4 (4.5)	0.173
	PEP	6 (3.6)	0	0.027^a	3 (3.4)	0	0.081
	Hyperamylasemia	8 (4.8)	0	0.010^a	4 (4.5)	0	0.043^a
	Cholangitis	2 (1.2)	1 (0.7)	0.699	1 (1.1)	1 (1.1)	1.000
	Bile leakage	0	5 (3.7)	0.012^a	0	2 (2.3)	0.155
	Port site infection	0	6 (4.8)	0.006^b	0	2 (2.3)	0.155

¹Procedure time in the open choledochotomy group was exclusively for common bile duct exploration.

²Retained stones were evacuated by endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation at a later date.

³Hospital stay for the EST group was defined as the duration of post-EST stay plus post-cholecystectomy stay.

^aP < 0.05.

^bP < 0.01.

EST: Endoscopic sphincterotomy; OCT: Open choledochotomy; OC: Open cholecystectomy; LC: Laparoscopic cholecystectomy; PEP: Post-endoscopic retrograde cholangio pancreatography pancreatitis; SD: standard deviation; IQR: Interquartile range.

Table 3 Procedure-related long-term outcomes of endoscopic sphincterotomy and open choledochotomy

Long-term outcome measure		Before matching			After matching
Long-term outcome measure		EST (n = 168)	OCT (n = 134)	P-value	EST (n = 88)	OCT (n = 88)	P-value
Recurrent bile duct stones, n (%)		29 (17.3)	32 (23.9)	0.155	18 (20.5)	15 (17.0)	0.562
	With AC	4 (2.4)	12 (8.9)	0.036^a	2 (2.4)	6 (8.9)	0.054
	Without AC	25 (14.9)	20 (14.9)	0.036^a	16 (14.9)	9 (14.9)	0.054
Time to initial recurrence, mean ± SD, yr		2.8 ± 2.0	3.5 ± 2.2	0.183	3.0 ± 2.2	3.9 ± 2.7	0.321
Times of recurrence ≥ 2, n (%)		6 (3.6)	11 (8.2)	0.082	3 (3.4)	4 (4.5)	0.700
Reintervention rate, n (%)		24 (14.3)	29 (21.6)	0.095	15 (17.0)	14 (15.9)	0.839
Reintervention method, n (%)				0.002^b			0.032^a
	EST	23 (13.7)	¹15 (11.2)		14 (15.9)	¹7 (7.9)
	OCT	1 (0.6)	13 (9.7)		1 (1.1)	6 (6.8)
	LCBDE	0	1 (0.7)		0	1 (1.1)
Mortality, n (%)		14 (8.3)	11 (8.2)	0.969	10 (11.4)	9 (10.2)	0.808
	Procedure-related	0	0	-	0	0	-
	Cholangiocarcinoma	0	2 (1.5)	0.112	0	1 (1.1)	0.316
	Cardiopulmonary complication	8 (4.8)	4 (3.0)	0.432	7 (7.9)	4 (4.5)	0.350
	Unknown etiology	6 (3.6)	5 (3.7)	0.941	3 (3.4)	4 (4.5)	0.700

¹In the open choledochotomy group, 15 reinterventions for endoscopic sphincterotomy were required due to purely recurrent common bile duct stones (CBDS) (n = 8), recurrent CBDS with acute cholangitis (n = 6), or recurrent CBDS with cholangiocarcinoma (n = 1).

^aP < 0.05.

^bP < 0.01.

EST: Endoscopic sphincterotomy; OCT: Open choledochotomy; AC: Acute cholangitis; LCBDE: Laparoscopic common bile duct exploration; SD: Standard deviation; IQR: Interquartile range.

Table 4 Risk factors for common bile duct stone recurrence

Variable		Recurrence, n (%)		P-value	Multivariate analysis
Variable		No (n = 241)	Yes (n = 61)	P-value	OR (95%CI)	P-value
Age, mean ± SD, yr		57.2 ± 14.3	57.3 ± 14.1	0.974	-	-
Sex (female)		131 (54.4)	33 (54.1)	0.971	-	-
Intervention method				0.156		0.841
	OCT	102 (42.3)	32 (52.5)		Reference
	EST	139 (57.7)	29 (47.5)		0.93 (0.47-1.86)
Bile duct diameter, cm				< 0.001^b		0.011^b
	< 15	180 (74.7)	25 (41.0)		Reference
	≥ 15	61 (25.3)	36 (59.0)		2.72 (1.26-5.87)
Distal CBD angle ≤ 145°		78 (32.4)	37 (60.6)	< 0.001^b	2.92 (1.54-5.55)	0.001^b
Stone number				< 0.001^b		< 0.001^b
	Single	167 (69.3)	15 (24.6)		Reference
	Multiple	74 (30.7)	46 (75.4)		5.09 (2.58-10.07)
Maximum stone size, mm				0.002^b		0.904
	< 20	216 (89.6)	45 (73.8)		Reference
	≥ 20	25 (10.4)	16 (26.2)		1.06 (0.43-2.63)
Mechanical lithotripsy		9 (3.7)	3 (4.9)	0.673	-	-
Bacterial cholangitis		63 (26.1)	13 (21.3)	0.438	-	-
Previous gastrectomy
	Billroth-I	6 (2.5)	1 (1.6)	0.696	-	-
	Billroth-II	6 (2.5)	3 (4.9)	0.328	-	-
Hypertension		26 (10.8)	8 (13.1)	0.608	-	-
Diabetes mellitus		17 (7.1)	1 (1.6)	0.145	0.29 (0.03-2.51)	0.261
Charlson comorbidity index, mean ± SD		0.7 ± 0.9	0.6 ± 0.9	0.499	-	-

^aP < 0.05.

^bP < 0.01.

EST: Endoscopic sphincterotomy; OCT: Open choledochotomy; CBD: Common bile duct; OR: Odds ratio; CI: Confidence interval; SD: Standard deviation; IQR: Interquartile range.

Citation: Zhou XD, Chen QF, Zhang YY, Yu MJ, Zhong C, Liu ZJ, Li GH, Zhou XJ, Hong JB, Chen YX. Outcomes of endoscopic sphincterotomy vs open choledochotomy for common bile duct stones. World J Gastroenterol 2019; 25(4): 485-497
URL: https://www.wjgnet.com/1007-9327/full/v25/i4/485.htm
DOI: https://dx.doi.org/10.3748/wjg.v25.i4.485