Short-type single balloon enteroscope for endoscopic retrograde cholangiopancreatography with altered gastrointestinal anatomy

Table 1 Baseline characteristics of the patients n (%)

	Billroth-II gastrectomy	Roux-en-Y gastrectomy	Roux-en-Y hepatico-jejunostomy	Total No. of SIF-Y0004-assisted ERCP
	(n = 8)	(n = 21)	(n = 2)	(n = 31)
Age1, mean (range), yr	75.4 (62-82)	71.3 (50-85)	65 (65)	72.0 (50-85)
Sex2:
Male	5 (83)	13 (93)	2 (100)	20 (91)
Female	1 (17)	1 (7)	0 (0)	2 (9)
Reasons for surgery1
Gastric ulcer	2 (25)	0 (0)	0 (0)	2 (6.5)
Duodenum ulcer	2 (25)	2 (9.5)	0 (0)	4 (13)
Carcinoma of the stomach	4 (50)	19 (90.5)	0 (0)	23 (74)
Carcinoma of the pancreas	0 (0)	0 (0)	2 (100)	2 (6.5)
Reasons for ERCP1
AOSC (due to CBD stone)	1 (12.5)	1 (5)	0 (0)	2 (6.5)
Carcinoma of the pancreas	2 (25)	0 (0)	0 (0)	2 (6.5)
Carcinoma of the gallbladder	1 (12.5)	0 (0)	0 (0)	1 (3.3)
CBD stone	3 (37.5)	14 (66)	2 (100)	19 (61)
IPMN	0 (0)	1 (5)	0 (0)	1 (3.3)
IPNB suspected	0 (0)	1 (5)	0 (0)	1 (3.3)
Metastasis of L/N in porta hepatis	1 (12.5)	4 (19)	0 (0)	5 (16)

¹No. of procedures;

²No. of patients. AOSC: Acute obstructive suppurative cholangitis; CBD: Common bile duct; IPMN: Intraductal papillary mucinous neoplasm; IPNB: Intraductal papillary neoplasm of the bile duct; ERCP: Endoscopic retrograde cholangiopancreatography.

Table 2 Specifications of two types of single-balloon endoscopes

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

Table 3 Summary of results n (%)

	Billroth-II gastrectomy(n = 8)	Roux-en-Y gastrectomy(n = 21)	Roux-en-Y Hepatico-jejunostomy (n = 2)	Total No. of SIF-Y0004-assisted ERCP (n = 31)
Reaching the blind end	7 (88)	19 (91)	2 (100)	28 (90)
Mean time (min) to reach the blind end (range)	18.3 (5-37)	21.1 (10-37)	32.5 (32-33)	21.2 (5-37)
Diagnostic success
Total	6 (86)	17 (90)	2 (100)	25 (89)
Intact papilla	6 (86)	13 (87)	-	19 (86)
Therapeutic intervention required
Total	5 (83)	16 (94)	2 (100)	23 (92)
Intact papilla	5 (83)	12 (92)	-	17 (89)
Therapeutic success
Total	5 (100)	15 (94)	2 (100)	22 (96)
Intact papilla	5 (100)	11 (92)	-	16 (94)
Mean procedure time (min) (range)	35.4 (7-65)	43.3 (12-125)	46.5 (26-41)	40.2 (7-125)

ERCP: Endoscopic retrograde cholangiopancreatography.

Table 4 Treatment procedures

	Billroth-II gastrectomy	Roux-en-Y gastrectomy	Roux-en-Y Hepatico-jejunostomy	Total No. of SIF-Y0004-assisted ERCP
EST	0	3	0	3
EPBD	2	5	0	7
EPLBD	1	4	1	6
EBD
Plastic stent	1	3	0	4
Metallic stent	2	2	0	4
Stone extraction
Wire-guided basket	1	9	2	12
Balloon catheter	0	1	0	1
Wire-guided IDUS	1	7	0	8

EBD: Endoscopic biliary drainage; EPBD: Endoscopic papillary balloon dilation; EPLBD: Endoscopic papillary large balloon dilation; EST: Endoscopic sphincterotomy; IDUS: Intraductal ultrasonography; ERCP: Endoscopic retrograde cholangiopancreatography.

Table 5 Complications n (%)

Complications	Billroth-II gastrectomy (n = 8)	Roux-en-Y gastrectomy (n = 21)	Roux-en-Y Hepatico-jejunostomy (n = 2)	Total No. of SIF-Y0004-assisted ERCP (n = 31)
Hyperamylasemia1
Total	1 (14.3)	4 (21.1)	-	5 (19.2)
Intact papilla	1 (14.3)	3 (20)	-	4 (18.2)
Pancreatitis2
Total	0 (0)	2 (10.5)	-	2 (7.7)
Intact papilla	0 (0)	2 (13.3)	-	2 (9.1)
Perforation of digestive tract	0 (0)	1 (4.8)	0 (0)	1 (3.2)
Bleeding of papilla2	0 (0)	1 (5.3)	0 (0)	1 (3.4)

¹Hyperamylasemia: More than 3 times the upper limit of normal;

²According to Cotton’s criteria. ERCP: Endoscopic retrograde cholangiopancreatography.