What does this research mean for the field?

Both 10 mm fully covered self-expandable metal stents placed for 12 months and 12 mm stents placed for 6 months are similarly effective treatments for benign biliary strictures secondary to chronic pancreatitis. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This study aims to assess the safety and feasibility of two durations of fully covered self-expandable metal stents for treating benign biliary strictures caused by chronic pancreatitis.

May 20, 2026Surgical Endoscopy0 citationsOpen Access

Covered self-expandable metal stents in benign biliary strictures caused by chronic pancreatitis: a randomized controlled trial of 6 versus 12 months of stenting

OLOuti LindströmUniversity of Helsinki MUMarianne UddUniversity of Helsinki JGJuha GrönroosTurku University Hospital

Key Points

This study aims to assess the safety and feasibility of two durations of fully covered self-expandable metal stents for treating benign biliary strictures caused by chronic pancreatitis.
Multicenter prospective randomized trial with 62 patients enrolled for ERCP treatment of biliary strictures.
Patients were assigned to receive either 10 mm stents for 12 months or 12 mm stents for 6 months.
Follow-up included liver function tests and abdominal ultrasound at 6 and 24 months after stent removal.
In the 10 mm group, recurrent strictures occurred in 3 of 24 patients (13%), while in the 12 mm group, it was 4 of 22 patients (18%) (p=0.694).
One stent in the 12 mm group migrated, requiring re-stenting; one patient in the 10 mm group had an impacted stent necessitating hepaticojejunostomy.
Overall, both types of stents appeared effective for treating biliary strictures.

Abstract

Abstract Background In chronic pancreatitis (CP), a symptomatic benign biliary stricture (BBS) evolves as an adverse event in 3–30%. Treatment by ERCP with a single plastic biliary stent has been disappointing. Multiple plastic stents are more successful but make the procedure more time consuming than treatment with a fully covered self-expandable metal stent (fcSEMS). The most efficient stenting duration of BBS caused by CP is not known. The aim of this multicenter prospective randomized study was to compare the safety and feasibility of 10 mm diameter fcSEMSs placed for 12 months versus 12 mm diameter fcSEMSs placed for 6 months in the treatment of BBS caused by CP. Methods The patients were randomized into two groups: either 10 mm diameter fcSEMS for 12 months or 12 mm diameter fcSEMS for 6 months. After stent removal, the patients were followed up at 6 and 24 months with liver function tests and abdominal ultrasound. Results A total of 62 consecutive patients undergoing ERCP for the treatment of BBS at six centers were enrolled. Four patients in the 10 mm group and five in the 12 mm group were excluded due to a diagnosis of pancreatic cancer, and two in the 10 mm and four in the 12 mm group were excluded because of death from other causes during the 2-year follow-up. In the 10 mm group, one stent became impacted in the bile duct necessitating hepaticojejunostomy; this patient was also excluded from the final analysis. The final sample size was 24 patients in the 10 mm group and 22 in the 12 mm group. In the 12 mm group, one stent migrated requiring re-stenting. Recurrent strictures occurred in 3 of 24 patients (13%) in the 10 mm group and in 4 of 22 patients (18%) in the 12 mm group ( p = 0.694). Conclusions Both types of fcSEMS are effective in the treatment of BBS secondary to CP. However, the increased risk of pancreatic cancer in these patients should be taken into consideration. Graphical abstract

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