Korean J Radiol.  2007 Oct;8(5):410-417. 10.3348/kjr.2007.8.5.410.

Treatment of Malignant Biliary Obstruction with a PTFE-Covered Self-Expandable Nitinol Stent

• Han YM
• Kwak HS
• Jin GY
• Lee SO
• Chung GH

• KMID: 1734290
• DOI: http://doi.org/10.3348/kjr.2007.8.5.410

Abstract

OBJECTIVE
We wanted to determine the technical and clinical efficacy of using a PTFE-covered self-expandable nitinol stent for the palliative treatment of malignant biliary obstruction. MATERIALS AND METHODS: Thirty-seven patients with common bile duct strictures caused by malignant disease were treated by placing a total of 37 nitinol PTFE stents. These stents were covered with PTFE with the exception of the last 5 mm at each end; the stent had an unconstrained diameter of 10 mm and a total length of 50-80 mm. The patient survival rate and stent patency rate were calculated by performing Kaplan-Meier survival analysis. The bilirubin, serum amylase and lipase levels before and after stent placement were measured and then compared using a Wilcoxon signed-rank test. The average follow-up duration was 27.9 weeks (range: 2-81 weeks). RESULTS: Placement was successful in all cases. Seventy-six percent of the patients (28/37) experienced adequate palliative drainage for the remainder of their lives. There were no immediate complications. Three patients demonstrated stent sludge occlusion that required PTBD (percutaneous transhepatic biliary drainage) irrigation. Two patients experienced delayed stent migration with stone formation at 7 and 27 weeks of follow-up, respectively. Stent insertion resulted in acute elevations of the amylase and lipase levels one day after stent insertion in 11 patients in spite of performing endoscopic sphincterotomy (4/6). The bilirubin levels were significantly reduced one week after stent insertion (p < 0.01). The 30-day mortality rate was 8% (3/37), and the survival rates were 49% and 27% at 20 and 50 weeks, respectively. The primary stent patency rates were 85%, and 78% at 20 and 50 weeks, respectively. CONCLUSION: The PTFE-covered self-expandable nitinol stent is safe to use with acceptable complication rates. This study is similar to the previous studies with regard to comparing the patency rates and survival rates.

Keyword

Biliary tract, malignant obstruction; Biliary tract, interventional procedures; Prosthesis, stent

MeSH Terms

Adenocarcinoma/*complications
Aged
Aged, 80 and over
Alloys/adverse effects/*therapeutic use
Cholestasis, Extrahepatic/etiology/*surgery
Coated Materials, Biocompatible/*therapeutic use
Common Bile Duct/radiography/surgery
Digestive System Neoplasms/*complications
Equipment Design
Female
Follow-Up Studies
Humans
Male
Middle Aged
Palliative Care/methods
Pilot Projects
Polytetrafluoroethylene/adverse effects/*therapeutic use
Postoperative Complications/diagnosis/epidemiology
Prospective Studies
*Stents/adverse effects
Survival Analysis
Treatment Outcome

Figure

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  Fig. 1 The PTFE-covered self-expanding Niti-S stent endoprosthesis. The stent is a woven, monofilament structure composed of nitinol, and it is covered on its interior surface by PTFE.

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  Fig. 2 A 68-year-old female with common bile duct carcinoma. A. The tubogram taken immediately after stent insertion shows good stent patency and correct positioning. B. This one-week follow-up tubogram shows good stent function. The distance between the end of the stent and the bifurcation of the common hepatic duct shows no change.

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  Fig. 3 The graph shows the changes of the amylase and lipase level before and after stent placement and during the last follow-up.

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  Fig. 4 A 78-year-old female with common bile duct carcinoma. A. The one-week follow-up tubogram shows a well functioning stent. B. This 33-week follow-up tubogram after percutaneous transhepatic biliary drainage shows no contrast medium, due to food reflux, in the stent (arrows). C. The tubogram after stent irrigation shows good passage of contrast medium into the duodenum. Small remnants of food material (arrows) were observed in the left intrahepatic duct and in the distal portion of the stent.

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  Fig. 5 A 76-year-old female with Ampulla of Vater carcinoma. A. The five-day follow-up plain film after stent insertion shows good stent positioning on the air-biliary gram (arrows). B. The 27-week follow-up tubogram after percutaneous transhepatic biliary drainage shows no evidence for the presence of a stent, and there is a small filling defect in the distal common bile duct, which may be a common bile duct stone (arrows).

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