DIGITAL SINGLE-OPERATOR CHOLANGIOSCOPY IN DIAGNOSTIC AND THERAPEUTIC BILIO-PANCREATIC DISEASES: A PROSPECTIVE, MULTICENTER STUDY

Aims Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases.

We aimed to investigate the efficacy and safety of D-SOC for both diagnostic and therapeutic indications.

Methods This is a multicenter, prospective study (January 2016-June 2019). The primary outcome was to evaluate the procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events for all indications.

Results Eighteen Italian tertiary referral centers participated in the study. D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients.

The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively.

For biliary stones management, complete duct clearance was obtained in 92,1% patients of whom 82,1% in a single session.

Overall, adverse events(AEs) occurred in 37(10%) cases, for which cholangitis was the most common(14, 3,8%). The grade of AEs was mild or moderate for all the cases, except one which was fatal.

Conclusions D-SOC is effective for both diagnostic and therapeutic indications. Most of the AEs were minor and managed conservatively, even though a fatal event has happened in our series that is not negligible and should be considered before using D-SOC for the management of patients with complex bilio-pancreatic diseases.

Publication History

Article published online:
14 April 2022