Newly designed stent for endoscopic bilateral stent-in-stent placement of metallic stents in patients with malignant hilar biliary strictures: multicenter prospective feasibility study (with videos).

Abstract

BACKGROUND:

Endoscopic management of malignant hilar biliary strictures is difficult even for an experienced endoscopist. Moreover, endoscopic placement of bilateral metal stents is considered very difficult and complicated.

OBJECTIVE:

We explored the feasibility and efficacy of the placement of a newly designed metal stent for an endoscopic bilateral stent-in-stent procedure for the management of malignant hilar biliary strictures.

DESIGN:

Multicenter prospective feasibility study.

SETTING:

Five academic tertiary referral centers.

PATIENTS:

Thirty-five patients with malignant hilar biliary strictures of Bismuth type II or higher were enrolled.

INTERVENTIONS:

Bilateral stent placement by an endoscopic stent-in-stent procedure.

MAIN OUTCOME MEASUREMENTS:

Technical success, functional success, early and late complications, stent patency.

RESULTS:

The overall technical success rate of the newly designed metal stent was 94.3% (33/35). The success rate of the stent-in-stent procedure in a single session was 82% (27/33) per protocol and 77% (27/35) as intent to treat. In cases in which the initial stent-in-stent procedure failed, patients underwent the endoscopic stent-in-stent procedure for contralateral stent placement at 2 days (6%, 2/33) or 4 days (12%, 4/33) after the initial stent placement. There was no percutaneous insertion of a contralateral stent in these patients. There was no stent-related early or late complication in any enrolled patient. Functional success was 100% (33/33). Reintervention because of stent malfunction was 6% (2/33). These 2 patients showed sludge formation in the stent. During follow-up, there was no stent tumor ingrowth or overgrowth in the placed stent in any enrolled patient. According to the Kaplan-Meier analysis, median survival and stent patency were 180 days and 150 days, respectively.

LIMITATIONS:

An uncontrolled feasibility study with a small patient population and a limited follow-up period.

CONCLUSION:

The newly designed metal stent for the endoscopic bilateral stent-in-stent procedure may be feasible and effective for malignant hilar biliary strictures.

• Authors: Do Hyun Park, Sang Soo Lee, Jong Ho Moon, Hyun Jong Choi, Sang-Woo Cha, Jong Hyeok Kim, Dong-Wan Seo, Sung-Koo Lee, Sang-Heum Park, Moon-Sung Lee, Sun-Joo Kim, Myung-Hwan Kim
• Journal: Gastrointestinal endoscopy (Gastrointest Endosc) Vol. 69 Issue 7 Pg. 1357-60 (Jun 2009) ISSN: 1097-6779 [Electronic] United States
• PMID: 19481654 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Biocompatible Materials
• Metals

Topics

• Adult
• Aged
• Biliary Tract Neoplasms (therapy)
• Biocompatible Materials
• Constriction, Pathologic (therapy)
• Endoscopy, Digestive System
• Feasibility Studies
• Female
• Humans
• Male
• Metals
• Middle Aged
• Prospective Studies
• Stents
• Treatment Outcome