Prospective evaluation of a newly designed T-configured stent graft system for palliative treatment of advanced hilar malignant biliary obstructions.
OBJECTIVE
To investigate the technical and clinical safety and efficacy of using a newly designed T-configured stent graft for palliative treatment of advanced hilar malignant biliary obstructions.


METHODS
This is a prospective study that enrolled 30 patients who had malignant hilar obstructions from May 2007 to November 2008. All patients were treated with percutaneous transhepatic placement of two specially designed stent grafts in a T configuration. Technical success, evaluation of blocked branching ducts, complications, clinical success, stent patency time, and patient survival rates were analyzed.


RESULTS
Stent graft deployment was technically successful in all patients. The bilirubin level and the bile duct diameter decreases were statistically significant after stent placement (P < .001), and all patients showed clinical improvement. Minor complications, including procedure-related complications (self-limiting hemobilia [n = 3], perihepatic biloma [n = 1], and acute pancreatitis [n = 1]) and rapidly resolving cholangitis (n = 5), occurred in ten patients (33.3%). Major complications, including acute cholecystitis, occurred in three patients (10%). Stent occlusion occurred in 12 patients (40%) after a mean period of 160 days (range, 82-307 days). The median survival and stent patency times were 334 days (range, 195.6-472.4 days) and 279 days (range, 194.7-363.3 days), respectively. There were no statistical differences in age, sex, Bismuth type, or number of blocked branching ducts.


CONCLUSIONS
The initial results of percutaneous palliative treatment of advanced hilar malignancies with T-configured stent grafts suggest that they are safe and potentially clinically effective.
Gwon
Dong Il
DI
Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, 86, Asanbyeongwon-gil, Songpa-gu, Seoul, 138-736, Korea.
Ko
Gi-Young
GY
Yoon
Hyun-Ki
HK
Kim
Jin Hyoung
JH
Lee
Jae Myeong
JM
Ohm
Joon-Young
JY
Sung
Kyu-Bo
KB
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000150:complications* / Q000000981:diagnostic imaging / Q000401:mortality; D002758:Cholangiography; D002779:Cholestasis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D004322:Drainage / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D056910:Republic of Korea; D015607:Stents; D015996:Survival Rate; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome