BACKGROUND: Fully covered self-expandable metal stents (FCSEMS) are increasingly used for treatment of benign common bile duct (CBD) stricture or leakage, but dislodgement of FCSEMS is frequent. AIMS: To compare dislocation rate and clinical outcome of a standard fixed cell structure FCSEMS (S-FCSEMS) to a novel FCSEMS with an unfixed cell structure (N-FCSEMS). METHODS: We performed a retrospective analysis of all patients with FCSEMS insertion for benign biliary disease at our Hospital from 03/2008 to 03/2014. Both stent types N-FCSEMS and S-FCSEMS were applied as available unrelated to the indication. RESULTS: Twenty-nine patients (S-FCSEMS: 18, N-FCSEMS: 11) were included. Stent placement was technically successful in 28/29 (96.6 %) patients; stent removal was successful in 26/27 (96.2 %). Two patients with N-FCSEMS were excluded due to unsuccessful placement and withdrawal of consent for stent removal, respectively. Stent migration into the duodenum (distal migration) was observed in 9/18 (50 %) in the S-FCSEMS group compared to 0/9 in the N-FCSEMS (p < 0.005). FCSEMS migration into the CBD (proximal migration) was found in 2/18 (11 %, S-FCSEMS) versus 2/9 (22 %, N-FCSEMS, p = 0.514). A foreshortening of the N-FCSEMS occurred in 3/9 patients (33 %) compared to 0/18 S-FCSEMS (p = 0.08). Clinical resolution of the treated CBD-disease was observed in 5/9 (56 %, N-FCSEMS) versus 12/18 (67 %, S-FCSEMS) at the time of stent removal (p = 0.604) and in 0/9 and 10/18 (56 %) cases during follow-up, respectively (p < 0.005). CONCLUSION: An unfixed cell structure of FCSEMS seems to prevent distal migration, but proximal migration still occurs and foreshortening of the N-FCSEMS constrains clinical outcome.
BACKGROUND: Fully covered self-expandable metal stents (FCSEMS) are increasingly used for treatment of benign common bile duct (CBD) stricture or leakage, but dislodgement of FCSEMS is frequent. AIMS: To compare dislocation rate and clinical outcome of a standard fixed cell structure FCSEMS (S-FCSEMS) to a novel FCSEMS with an unfixed cell structure (N-FCSEMS). METHODS: We performed a retrospective analysis of all patients with FCSEMS insertion for benign biliary disease at our Hospital from 03/2008 to 03/2014. Both stent types N-FCSEMS and S-FCSEMS were applied as available unrelated to the indication. RESULTS: Twenty-nine patients (S-FCSEMS: 18, N-FCSEMS: 11) were included. Stent placement was technically successful in 28/29 (96.6 %) patients; stent removal was successful in 26/27 (96.2 %). Two patients with N-FCSEMS were excluded due to unsuccessful placement and withdrawal of consent for stent removal, respectively. Stent migration into the duodenum (distal migration) was observed in 9/18 (50 %) in the S-FCSEMS group compared to 0/9 in the N-FCSEMS (p < 0.005). FCSEMS migration into the CBD (proximal migration) was found in 2/18 (11 %, S-FCSEMS) versus 2/9 (22 %, N-FCSEMS, p = 0.514). A foreshortening of the N-FCSEMS occurred in 3/9 patients (33 %) compared to 0/18 S-FCSEMS (p = 0.08). Clinical resolution of the treated CBD-disease was observed in 5/9 (56 %, N-FCSEMS) versus 12/18 (67 %, S-FCSEMS) at the time of stent removal (p = 0.604) and in 0/9 and 10/18 (56 %) cases during follow-up, respectively (p < 0.005). CONCLUSION: An unfixed cell structure of FCSEMS seems to prevent distal migration, but proximal migration still occurs and foreshortening of the N-FCSEMS constrains clinical outcome.
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