A Short Fully Covered Self-Expandable Metal Stent for Management of Benign Biliary Stricture Not Caused by Living-Donor Liver Transplantation

Abstract

Background: This study evaluated the effectiveness of short fully covered self-expanding metal stents (FCSEMS) with an anti-migration design in treating benign biliary strictures (BBS) not related to living donor liver transplantation (LDLT). Methods: A retrospective analysis was conducted on 75 patients who underwent FCSEMS insertion for BBS management. Stents were initially kept for 3 months and exchanged every 3 months until stricture resolution. Adverse events and stricture recurrence after FCSEMS removal were assessed during follow-up. Results: The study outcomes were technical success, stenosis resolution, and treatment failure. Technical success was 100%, with stricture resolution in 99% of patients. The mean onset time of BBS post-surgery was 4.4 years, with an average stent indwelling period of 5.5 months. Stricture recurrence occurred in 20% of patients, mostly approximately 18.8 months after stent removal. Early cholangitis and stent migration were noted in 3% and 4% of patients, respectively. Conclusions: This study concludes that short FCSEMS demonstrate high efficacy in the treatment of non-LDLT-related BBS, with a low incidence of interventions and complications. Although this is a single-center, retrospective study with a limited sample size, the findings provide preliminary evidence supporting the use of short FCSEMS as a primary treatment modality for BBS. To substantiate these findings, further research involving multicenter studies is recommended to provide additional validation and a broader perspective.

Keywords: benign biliary stricture; endoscopic retrograde cholangiopancreatography; fully covered self-expanding metal stent.

Figure 1

An example of a short FCSEMS (Niti-S KAFFES Biliary Stent). This biliary stent is engineered for complete insertion within the biliary tract and features a retrieval string that extends to the duodenum, facilitating its extraction from the common bile duct. Its distinctive design incorporates a ‘waist’ that gradually tapers at the midpoint, effectively preventing migration. Additionally, the stent is equipped with radiopaque markers: three are positioned at each end and two in the middle, enabling precise placement of the metal stent at the center of the stricture.

Figure 2

FCSEMS treatment of biliary anastomotic stricture after cholecystectomy. A case of biliary anastomotic stricture diagnosed after cholecystectomy and treated with FCSEMSs is presented. (A) A biliary anastomotic stricture that had developed after surgery was observed in the common bile duct on cholangiography. (B) The stent was positioned before deployment such that the central radiopaque marker was aligned with the stenosis. (C) An FCSEMS (6 mm in diameter, 4 cm in length; KAFFES) was deployed at the site of biliary anastomotic stricture. (D) After 9 months of FCSEMS use, including two replacements, the stent was removed, and the procedure was terminated after confirming that the biliary anastomotic stricture had resolved.

Figure 3

FCSEMS treatment of biliary anastomotic stricture after DDLT. A case of biliary anastomotic stricture that developed after DDLT for alcoholic cirrhosis and treated with FCSEMSs is presented. (A) A magnetic resonance cholangiopancreatograph was performed to visualize the shape and length of the stricture. A common bile duct stricture is shown. (B) A common bile duct stricture was observed on cholangiogram. (C) An FCSEMS (8 mm in diameter, 4 cm in length; KAFFES) stent was deployed so that the central radiopaque marker was centered in the stenosis. (D) The FCSEMS is shown at the stricture site, and the retrieval string is located at the duodenum (color figure). (E) After stent indwelling for 3 months, the FCSEMS was found to be completely self-inflating, and the FCSEMS is removed by grasping the retrieval string using grasping forceps (color panel). (F) After three months of FCSEMS, including one replacement, the stent was removed and the biliary anastomotic stricture resolved.

Figure 4

FCSEMS treatment of biliary anastomotic stricture after liver resection. A case diagnosed with biliary anastomotic stricture after left hemihepatectomy for liver donation and treated with FCSEMSs is presented. (A) Magnetic resonance cholangiopancreatography shows segmental narrowing at the hilar and common hepatic duct with mild central intrahepatic bile duct dilatation, and a 2 cm-sized biloma was observed at the resection margin. (B) A hilar stricture was observed on cholangiogram. (C) An FCSEMS (6 mm in diameter, 5 cm in length; KAFFES) was deployed at the site of biliary anastomotic stenosis, with a plastic stent placed prophylactically, as expansion of the FCSEMS could narrow the adjacent branches. (D) After the FCSEMS was in use for 6 months, including one replacement, the stent was removed, and the procedure was terminated after confirming that the biliary anastomotic stricture was resolved.

Figure 5

FCSEMS treatment of BBS. A case of BBS diagnosed by histological findings and treated with FCSEMSs is presented. (A) Cholangiography with PTBD confirmed left biliary stricture. (B) Percutaneous transhepatic cholangioscopy was used for histological examination. (C) Histological examination was performed on the area of biliary stricture. (D) An FCSEMS (10 mm in diameter, 4 cm in length; KAFFES) was inserted into the BBS. (E) The FCSEMS was successfully deployed. (F) After 12 months of FCSEMS use, including three replacements, the stent was removed, and the procedure was terminated after confirming that the BBS had resolved.

Figure 6

Kaplan–Meier curves on stricture resolution and recurrence. (A) The cumulative recurrence-free rates for a short FCSEMS use were 98.5% (95% CI: 0.96–1.00) at one year and 80.7% (95% CI: 0.70–0.93) at five years. (B) The stricture resolution rates for a short FCSEMS were 66.7% (95% CI: 0.53–0.79) at six months and 95.8% (95% CI: 0.93–0.99) at one year.