Evaluation of a newly modified nonflared fully covered metal stent, 12 mm in diameter, for intraductal placement in patients with malignant biliary strictures: a feasibility study.
OBJECTIVE
The nonflared ends of fully covered, self-expandable, metal stents (FCSEMSs) may minimize stent-induced ductal injury. Suprapapillary intraductal placement of nonflared FCSEMSs for malignant biliary stricture might reduce duodenobiliary reflux and pancreatitis. The aim of this study was to evaluate the efficacy of a newly modified, nonflared FCSEMS for intraductal placement in patients with malignant biliary stricture.


METHODS
A total of 51 patients with nonhilar, extrahepatic, malignant biliary stricture were enrolled prospectively. The nonflared FCSEMS is 12 mm in diameter, and has a central saddle and a distal lasso of 7 cm in length. An FCSEMS was placed above the papilla in all patients, with the central saddle positioned at the stricture to prevent stent migration.


RESULTS
The technical and clinical success rates were 100 % and 98 %, respectively. Early adverse events occurred in one patient (2.0 %; mild pancreatitis). A total of 12 patients underwent surgery with curative intent, one of whom (8.3 %) experienced a postoperative adverse event. No stent migration occurred in any of the patients. Cholecystitis developed in one patient (2.0 %) as a late adverse event. Stent occlusion occurred in 44.7 % (17/38), and endoscopic removal of the stent was successful in 87.5 % of patients. The mean stent patency was 297 days (95 % confidence interval, 211 - 383).


CONCLUSIONS
Intraductal placement of the nonflared FCSEMS, 12 mm in diameter, was feasible for the palliative and preoperative management of patients with malignant biliary stricture. Long-term follow-up and prospective comparative studies are needed to evaluate the usefulness of intraductal placement of this stent.
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Hyun Jong
HJ
Choi
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Jong Ho
JH
Moon
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Yun Nah
YN
Lee
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Hyun Su
HS
Kim
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Moon Han
MH
Choi
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Tae Hoon
TH
Lee
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Sang-Woo
SW
Cha
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Young Deok
YD
Cho
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Sang-Heum
SH
Park
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
Sun-Joo
SJ
Kim
D000368:Aged; D017734:Bile Ducts, Extrahepatic; D002764:Cholecystitis / Q000209:etiology; D002779:Cholestasis / Q000209:etiology / Q000628:therapy*; D004067:Digestive System Neoplasms / Q000150:complications*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology; D011446:Prospective Studies; D019919:Prosthesis Implantation; D000069322:Self Expandable Metallic Stents / Q000009:adverse effects