New 14-mm diameter Niti-S biliary uncovered metal stent for unresectable distal biliary malignant obstruction

Table 1 Patient characteristics

	n = 38
Men/women	21/17
Age (yr)	70 (52-90)
PS (0/1/2)	8/21/9
Diagnosis
Pancreatic cancer	36
Bile duct cancer	1
Metastatic nodes	1
Clinical stage III/IV	1/37
Tumor size (mm)	33 (13-70)
Length of the biliary stricture (mm)	27 (10-60)
Maximum diameter of the proximal bile duct (mm)	13.5 (7-20)

PS: Performance status.

Table 2 Results of stent placement

	n (%)
Technical success	38 (100)
Functional success	38 (100)
Selected stent length (60/80 mm)	14/24 (36.8/63.2)
Endoscopic sphincterotomy	20 (52.6)
Previous drainage (RBD/NBD)	9/2 (23.7/5.3)
Replacement for CSEMS	5 (13.2)

RBD: Retrograde biliary drainage; NBD: Naso-biliary drainage; CSEMS: Covered self-expandable metal stent.

Table 3 Retrograde biliary drainage, time to retrograde biliary drainage, and survival time

	n (%)
RBO	2 (5.3)
Tumor ingrowth	1 (2.6)
Tumor overgrowth	1 (2.6)
Median TRBO (d)	190 (164-215)
Non-obstruction rates of 3, 6, 12 mo (%)	100, 91, 78
Median survival time (d)	120 (18-502)

RBO: Recurrent biliary obstruction; TRBO: Time to recurrent biliary obstruction.

Table 4 Complications other than recurrent biliary obstruction

Complications	11/38 (28.9%)	Time to event (d)
Acute cholecystitis	4 (10.3)	3, 32, 217, 487
PEP	3 (7.9)	1 (each)
Hemorrhage	2 (5.3)	92, 119
Fever without exacerbation of liver injury	1 (2.6)	1
Liver abscess	1 (2.6)	17

PEP: Post-ERCP pancreatitis; ERCP: Endoscopic retrograde cholangiopancreatography.