Comparison of clinical outcomes for single- and double-balloon enteroscope-assisted endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy

Table 1 Baseline characteristics of the included patients, n (%)/median (interquartile range)/mean ± SD

Variable	DBE (n = 247)	SBE (n = 247)	P value
Age, years	66.0 ± 15.4	68.4 ± 11.6	0.051
Sex			0.406
Male	146 (59.1)	156 (63.2)
Female	101 (40.9)	91 (36.8)
BMI, kg/m2	21.6 ± 2.8	21.6 ± 3.3	0.919
Smoking	40 (16.2)	34 (13.8)	0.528
Alcohol intake	27 (10.9)	33 (13.4)	0.491
Amounts of alcohol (bottle/week)	4.3 ± 5.0	2.3 ± 2.1	0.064
Presence of acute cholangitis on admission	104 (42.1)	92 (37.2)	0.312
PTBD prior ERCP	2 (0.8)	31 (12.6)	< 0.001
PTGBD prior ERCP	12 (4.9)	14 (5.7)	0.840
Initial laboratory findings
WBC, /μL	6900.0 (5300.0-9500.0)	5950.0 (4630.0-8345.0)	0.003
Hb, g/dL	11.8 (10.3-13.1)	11.4 (10.1-12.6)	0.140
Platelet, /μL	209.0 (164.0-272.0)	198.0 (157.0-248.5)	0.072
AST, IU/L	33.0 (24.0-81.0)	42.0 (25.0-92.0)	0.157
ALT, IU/L	30.0 (17.0-59.0)	36.0 (18.0-81.0)	0.151
Total bilirubin, mg/dL	0.8 (0.6-1.8)	0.8 (0.4-2.2)	0.411
Amylase, IU/L	61.0 (41.0-84.0)	65.0 (45.0-91.0)	0.325
Lipase, U/L	30.0 (16.0-60)	27.0 (18.0-50.0)	0.970
CRP, mg/L	2.0 (0.1-9.1)	1.2 (0.1-5.8)	0.011
Final diagnosis			< 0.001
Malignant biliary obstruction	53 (21.5)	33 (13.4)
Benign biliary obstruction	73 (29.6)	42 (17.0)
Bile duct stones	94 (38.1)	156 (63.2)
Pancreatic duct stones	3 (1.2)	0 (0.0)
Pancreatic duct stricture	8 (3.2)	5 (2.0)
Others	16 (6.5)	11 (4.5)
Reason of primary surgery			< 0.001
AOV cancer	21 (8.5)	7 (2.8)
Cholangiocarcinoma (or suspected)	36 (14.6)	33 (13.4)
Duodenal cancer	2 (0.8)	3 (1.2)
Gastric cancer	107 (43.3)	164 (66.4)
GB cancer	5 (2.0)	10 (4.0)
Pancreatic cancer (or suspected)	42 (17.0)	3 (1.2)
Other tumors	0 (0.0)	2 (0.8)
Bile duct or IHD stones	5 (2.0)	3 (1.2)
Biliary atresia	6 (2.4)	0 (0.0)
Choledochal cyst	5 (2.0)	5 (2.0)
PUD complication	12 (4.9)	9 (3.6)
Trauma or surgical injury	6 (2.4)	8 (3.2)
Type of primary surgery			< 0.001
PD with B-II	10 (4.0)	28 (11.3)
PD with B-II and Braun anastomosis	2 (0.8)	5 (2.0)
PD with R-Y	77 (31.2)	1 (0.4)
STG with B-II	49 (19.8)	42 (17.0)
STG with B-II and Braun anastomosis	7 (2.8)	37 (15.0)
STG with R-Y	40 (16.2)	30 (12.1)
TG with R-Y	23 (9.3)	69 (27.9)
BDR with R-Y	39 (15.8)	35 (14.2)

BMI: Body mass index; PTBD: Percutaneous transhepatic biliary drainage; ERCP: Endoscopic retrograde cholangiopancreatography; PTGBD: Percutaneous transhepatic gallbladder drainage; WBC: White blood cell; Hb: Hemoglobin; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; CRP: C-reactive protein; AOV: Ampulla of Vater; GB: Gallbladder; IHD: Intrahepatic duct; PUD: Peptic ulcer disease; PD: Pancreaticoduodenectomy; B-II: Billroth II reconstruction; R-Y: Roux-en-Y reconstruction; STG: Subtotal gastrectomy; TG: Total gastrectomy; BDR: Bile duct resection; DBE: Double-balloon enteroscopy; SBE: Single-balloon enteroscopy.

Table 2 Endoscopic findings between double-balloon enteroscopy and single-balloon enteroscopy group, n (%)/mean ± SD

Variable	DBE (n = 247)	SBE (n = 247)	P value
Type of JJstomy			0.002
None	59 (23.9)	70 (28.3)
End to side	48 (19.4)	75 (30.4)
Side to side	140 (56.7)	102 (41.3)
Preserved gastric anatomy	124 (50.2)	69 (27.9)	< 0.001
Used scope			< 0.001
Long DBE	15 (6.1)	0 (0.0)
Short DBE	222 (89.9)	0 (0.0)
Short DBE ≥ long DBE	2 (0.8)	0 (0.0)
Long DBE ≥ short DBE	8 (3.2)	0 (0.0)
Short SBE	0 (0.0)	230 (93.1)
Short SBE ≥ long SBE	0 (0.0)	3 (1.2)
Long SBE ≥ short SBE	0 (0.0)	14 (5.7)
Periampullary diverticulum	16 (6.5)	21 (8.5)	0.494
Time for intubation to JJ, minutes	6.4 ± 7.7	11.2 ± 10.8	< 0.001
Successful intubation time, minutes	14.1 ± 13.5	23.5 ± 22.3	< 0.001
Total procedure time, minutes	31.0 ± 18.5	65.2 ± 37.9	< 0.001
Selective cannulation time, minutes	3.9 ± 8.1	3.7 ± 6.8	0.780
Naive papilla	111 (44.9)	123 (49.8)	0.247
Intubation failure	14 (5.7)	9 (3.6)	0.393
Selective cannulation failure	26 (10.5)	16 (6.5)	0.147
Difficult cannulation	48 (19.4)	50 (20.2)	0.910
Double guidewire method	9 (3.6)	20 (8.1)	0.056
Pancreatic duct injection	14 (5.7)	3 (1.2)	0.014
Pancreatic sphincterotomy	0 (0.0)	2 (0.8)	0.479
EPBD	59 (23.9)	152 (61.5)	< 0.001
EST	5 (2.0)	70 (28.3)	< 0.001
Endobiliary biopsy	10 (4.0)	32 (13.0)	0.001
Intraductal balloon dilation	35 (14.2)	29 (11.7)	0.503
Biliary stent placement	90 (36.4)	69 (27.9)	0.054
Pancreatic stent placement	36 (14.6)	21 (8.5)	0.049

DBE: Double-balloon enteroscopy; SBE: Single-balloon enteroscopy; JJstomy: Jejunojejunostomy; EPBD: Endoscopic papillary balloon dilation; EST: Endoscopic sphincterotomy.

Table 3 Comparison of clinical outcomes between double-balloon enteroscopy and single-balloon enteroscopy group, n (%)/mean ± SD

Variable	DBE (n = 247)	SBE (n = 247)	P value
Overall technical success	218 (88.3)	229 (92.7)	0.125
Technical success in 1st session	217 (87.9)	226 (91.5)	0.237
Total adverse events	26 (10.5)	36 (14.6)	0.222
Sedation related AE	2 (0.8)	3 (1.2)	1.000
Post-procedure pancreatitis	12 (4.9)	21 (8.5)	0.149
Mild	12 (4.9)	16 (6.5)	0.125
Moderately severe	0 (0.0)	4 (1.6)
Severe	0 (0.0)	1 (0.4)
Pneumoperitoneum	5 (2.0)	1 (0.4)	0.218
Perforation	2 (0.8)	0 (0.0)	0.479
Significant bleeding	4 (1.6)	1 (0.4)	0.369
Post-ERCP cholecystitis	0 (0.0)	6 (2.4)	0.040
Post-ERCP cholangitis	1 (0.4)	9 (3.6)	0.025
Length of hospital stay, days, median (interquartile range)	5.0 (1.0-9.0)	5.0 (3.0-7.0)	0.054
Repeated ERCP within 30 days	33 (13.4)	26 (10.5)	0.405

DBE: Double-balloon enteroscopy; SBE: Single-balloon enteroscopy; ERCP: Endoscopic retrograde cholangiopancreatography; AE: Adverse event.

Table 4 Risk factors for the development of post-procedure adverse events

Variable	Univariable analysis		Multivariable analysis
	OR (95%CI)	P value	OR (95%CI)	P value
SBE (vs DBE)	1.74 (1.00-3.10)	0.052	1.62 (0.82-3.23)	0.164
Age > 65 years	1.01 (0.58-1.77)	0.984
Male sex	1.05 (0.60-1.68)	0.876
History of acute pancreatitis	0.42 (0.07-1.44)	0.245
Acute cholangitis on admission	1.38 (0.79-2.39)	0.256
PTBD prior ERCP	2.16 (0.83-5.00)	0.087	1.79 (0.66-4.38)	0.221
PTGBD prior ERCP	1.86 (0.60-4.80)	0.230
Resection
PD (vs BDR)	0.68 (0.22-2.20)	0.510	0.36 (0.07-1.68)	0.198
STG (vs BDR)	2.17 (0.93-5.97)	0.096	0.04 (0.00-0.54)	0.012
TG (vs BDR)	1.70 (0.62-5.11)	0.314	0.04 (0.00-0.53)	0.012
Reconstruction
B-II Braun (vs B-II)	0.48 (0.21-1.02)	0.063	0.60 (0.24-1.40)	0.245
R-Y (vs B-II)	0.64 (0.34-1.19)	0.154	0.49 (0.19-1.18)	0.126
Preserved gastric anatomy	0.33 (0.16-0.62)	0.001	0.03 (0.00-0.34)	0.003
Difficult cannulation	2.42 (1.31-4.34)	0.004	2.21 (1.12-4.32)	0.021
EPBD	1.19 (0.68-2.07)	0.530
EST	1.74 (0.86-3.34)	0.106	0.89 (0.38-1.97)	0.775
Biliary stent placement	1.03 (0.56-1.83)	0.921
Pancreatic stent placement	0.87 (0.32-1.99)	0.762

OR: Odds ratio; CI: Confidence interval; SBE: Single-balloon enteroscopy; DBE: Double-balloon enteroscopy; PTBD: Percutaneous transhepatic biliary drainage; ERCP: Endoscopic retrograde cholangiopancreatography; PTGBD: Percutaneous transhepatic gallbladder drainage; PD: Pancreaticoduodenectomy; BDR: Bile duct resection; STG: Subtotal gastrectomy; TG: Total gastrectomy; B-II: Billroth II reconstruction; R-Y: Roux-en-Y reconstruction; EPBD: Endoscopic papillary balloon dilation; EST: Endoscopic sphincterotomy.

Table 5 Risk factors for the intubation failure

Variable	Univariable analysis		Multivariable analysis
	OR (95%CI)	P value	OR (95%CI)	P value
SBE (vs DBE)	0.63 (0.26-1.46)	0.289
Age > 65 years	1.11 (0.48-2.71)	0.813
Male sex	0.99 (0.42-2.42)	0.979
Acute cholangitis on admission	1.18 (0.49-2.73)	0.703
PTBD prior ERCP	2.21 (0.50-6.90)	0.222
Resection
PD (vs BDR)	0.50 (0.17-1.45)	0.197
STG (vs BDR)	0.16 (0.04-0.54)	0.004
TG (vs BDR)	0.38 (0.10-1.24)	0.122
Reconstruction
B-II Braun (vs B-II)	7.34 (1.28-138.32)	0.064	5.13 (0.87-97.60)	0.132
R-Y (vs B-II)	8.69 (1.73-158.02)	0.037	8.65 (1.71-157.60)	0.038
Preserved gastric anatomy	3.09 (1.31-7.80)	0.012	3.18 (1.30-8.31)	0.013

OR: Odds ratio; CI: Confidence interval; SBE: Single-balloon enteroscopy; DBE: Double-balloon enteroscopy; PTBD: Percutaneous transhepatic biliary drainage; ERCP: Endoscopic retrograde cholangiopancreatography; PD: Pancreaticoduodenectomy; BDR: Bile duct resection; STG: Subtotal gastrectomy; TG: Total gastrectomy; B-II: Billroth II reconstruction; R-Y: Roux-en-Y reconstruction.