Passive-bending, short-type single-balloon enteroscope for endoscopic retrograde cholangiopancreatography in Roux-en-Y anastomosis patients

Table 1 Baseline characteristics of the patients n (% of procedures)

Characteristic	SIF-Y0004-V01 (n = 50)	SIF-Y0004 (n = 34)	P value	All SBE-assisted ERCP (n = 84)
Reconstruction method
Roux-en-Y gastrectomy	34 (68)	29 (85)	0.124	63 (75)
Roux-en-Y hepaticojejunostomy	16 (32)	5 (17)		21 (25)
Age, (yr) (mean ± SD)	71.4 ± 9.2	70.0 ± 11.0	0.529	70.8 ± 9.9
Sex
Male	40 (80)	31 (91)	0.168	71 (85)
Female	10 (20)	3 (9)		13 (15)
Reasons for surgery
Gastric ulcer	0 (0)	1 (3)	0.218	1 (1)
Duodenum ulcer	0 (0)	2 (6)	0.080	2 (2)
Carcinoma of the stomach	32 (64)	25 (73)	0.387	57 (68)
Malignant lymphoma of the stomach	2 (4)	0 (0)	0.238	2 (2)
Carcinoma of the duodenum	1 (2)	0 (0)	0.407	1 (1)
Tumors of the pancreas
Carcinoma of the pancreas	3 (6)	0 (0)	0.146	3 (4)
SCN	1 (2)	0 (0)	0.407	1 (1)
NET	1 (2)	0 (0)	0.407	1 (1)
Tumors of the biliary tract
Carcinoma of the bile duct	4 (8)	0 (0)	0.091	4 (5)
IPNB	2 (4)	3 (9)	0.345	5 (6)
Pancreaticobiliary maljunction	2 (4)	1 (3)	0.809	3 (4)
Congenital choledochal cyst	0 (0)	1 (3)	0.218	1 (1)
Other	2 (4)	1 (3)	0.809	3 (4)
Reasons for ERCP
AOSC (due to CBD stone)	0 (0)	2 (6)	0.080	2 (2)
Pancreatitis (due to CBD stone)	1 (2)	0 (0)	0.407	1 (1)
CBD stone	26 (52)	21 (62)	0.365	47 (56)
Intrahepatic stone	10 (20)	3 (9)	0.172	13 (16)
Carcinoma of the pancreas	2 (4)	1 (3)	0.809	3 (4)
Carcinoma of the gallbladder	1 (2)	0 (0)	0.407	1 (1)
Cholangiocellular carcinoma	3 (6)	0 (0)	0.146	3 (4)
IPMN	0 (0)	2 (6)	0.080	2 (2)
IPNB	2 (4)	4 (12)	0.165	6 (7)
Pancreaticobiliary maljunction	1 (2)	0 (0)	0.407	1 (1)
Metastasis of L/n in porta hepatis	0 (0)	5 (15)	0.005	5 (6)
Stricture of the anastomotic site	4 (8)	0 (0)	0.091	4 (5)
Other	1 (2)	1 (3)	0.769	2 (2)
Other abdominal or pelvic surgery	9 (18)	10 (29)	0.236	19 (23)
Peritoneal metastasis	0 (0)	2 (6)	0.080	2 (3)

AOSC: Acute obstructive suppurative cholangitis; ERCP: Endoscopic retrograde cholangiopancreatography; CBD: Common bile duct; IPMN: Intraductal papillary mucinous neoplasm; IPNB: Intraductal papillary neoplasm of the bile duct; NET: Neuroendocrine tumors; SCN: Serous cystic neoplasm.

Table 2 Specifications of three-types of single-balloon endoscopes

Variable	SIF-Y0004-V01	SIF-Y0004	SIF-Q260
Direction of view	Forward viewing	Forward viewing	Forward viewing
Angle of view	120°	120°	140°
Outer diameter (mm)
Distal end	9.2	9.2	9.2
Insertion end	9.2	9.2	9.2
Bending section
Up/down	180°/180°	180°/180°	180°/180°
Right/left	160°/160°	160°/160°	160°/160°
Working length (mm)	1520	1520	2000
Total length (mm)	1840	1840	2345
Working channel diameter (mm)	3.2	3.2	2.8
Water jet	Yes	Yes	No
Passive bending and high force transmission	Yes	No	No

Table 3 Endoscopic retrograde cholangiopancreatography sessions according to endoscopist, n (rate of reaching blind end)

Endoscopist	SIF-Y0004-V01 (n = 50)	SIF-Y0004 (n = 34)	P value	Experience with SBE-assisted ERCP, n
A	6 (83)	17 (88)	0.001	56
B	11 (91)	8 (88)	0.872	29
C	13 (85)	4 (100)	0.111	29
D	16 (94)	5 (100)	0.072	26
E	4 (100)	-	0.090	5

ERCP: Endoscopic retrograde cholangiopancreatography; SBE: Single-balloon enteroscopy.