Twelve-month Results From the Percutaneous Endoscopic Benign Biliary Laser Stricturotomy Study: A Prospective...

Benign biliary strictures (BBSs) are associated with poor long-term patency, substantial morbidity, and high health-care costs. Despite a multitude of available treatment options-peroral endoscopic, percutaneous transhepatic, and surgical reconstruction-recurrence rates remain high. This study assesses the safety and efficacy of percutaneous transhepatic cholangioscopy (PTCS)-assisted holmium laser stricturotomy for BBS management.

The Percutaneous Endoscopic Benign Biliary Laser study is a prospective, single-arm, open-label pilot trial conducted at a single academic institution. Between October 2022 and August 2023, 5 patients with BBSs underwent PTCS-assisted laser stricturotomy, with or without lithotripsy, using a holmium:yttrium-aluminum-garnet laser fiber. Patients were followed for 12 months. Primary endpoints included technical success and 30-day adverse events, while secondary endpoints assessed 12-month primary patency (freedom from stricture recurrence) and cumulative device-free survival. Data were gathered through imaging (magnetic resonance cholangiopancreatography or CT), clinical visits, and laboratory tests at 3, 6, and 12 months.

Technical success was achieved in 100% of cases, with all patients experiencing stricture resolution and biliary drain removal. Primary biliary patency was 80% (4 of 5), with 1 patient experiencing asymptomatic stricture recurrence and undergoing metallic stenting, remaining drain-free thereafter. Cumulative device-free survival averaged 9.4 ± 4.8 months. Three 30-day adverse events were noted in 2 patients: self-limited hemobilia, a bile leak, and a tract site infection.

PTCS-assisted holmium laser stricturotomy is a promising new treatment for benign biliary strictures, offering durable tube-free 12-month patency with an acceptable safety profile. The Percutaneous Endoscopic Benign Biliary Laser study provides a foundation for future clinical research to build upon and suggests that this emerging approach could augment traditional, less effective stenting protocols.