Endoscopic retrograde cholangiopancreatography (ERCP) can fail in some challenging situations, such as surgically altered anatomy, complex/intrahepatic biliary strictures, or difficult lithiasis. Percutaneous approach using digital single-use cholangioscopy (DSOC), eventually in combination with an endoscopic procedure (“rendezvous”) may provide a prompt and effective rescue option. The aim of this pilot study was to evaluate feasibility, safety, and effectiveness of percutaneous cholangioscope in the management of complex biliary diseases.

This single-center retrospective analysis included all consecutive patients who underwent percutaneous biliary access with the simultaneous collaboration between interventional radiologist and endoscopist (2021–24). Data were extracted from a prospectively maintained database. All procedures were performed under general anesthesia. DSOC with SpyGlass™ Discover (Boston Scientific) system was employed (always handled by the endoscopist) for direct visualization of biliary mucosa, selective biopsies (SpyBite™ forceps) or stone treatment through electrohydraulic lithotripsy (EHL with Autolith™). All patients received antibiotic prophylaxis, rectal indomethacin in case of a rendezvous procedure. Descriptive analysis was performed regarding baseline characteristics, clinical indication, therapeutic details, and adverse events.

Twelve patients were included (mean age 71.5 years; 7 females, 5 males). For 3 patients a rendez-vous procedure was performed (with contemporary endoscopic access from the papilla and a percutaneous one); the remaining 9 procedures were carried out through percutaneous access with the endoscopist managing the cholangioscope. Indications were predominantly choledocholithiasis and complex stone disease (n=8), followed by biliary strictures (n=4), including 2 cases of hilar cholangiocarcinoma. ERCP failure was previously reported in 50% of cases (6 pts), mainly due to duodenal diverticula (n=2), luminal strictures (n=2), altered anatomy such as Roux-en-Y or bilio-digestive anastomosis (n=1), or impossibility of oral intubation (n=1); 3 more patients had surgically altered anatomy directly approached in a percutaneous fashion. The largest biliary stone diameter ranged from 5 mm to 50 mm. EHL was required in 10 patients: 6 needed one session, 3 required two sessions, and 1 required three sessions to achieve complete clearance. Technical success of the combined procedure was obtained in all patients, allowing biliary drainage, stone removal, or targeted biopsies when indicated. Among the 4 cases of biliary strictures, 3 were subjected to biopsy sampling obtaining diagnostic confirmation of malignancy (n=2) or inflammation (n=1). Safety evaluation showed a low complication rate: 8 patients experienced no adverse events. Four complications occurred overall: 2 cases of post-procedural fever managed conservatively (antibiotc therapy), 1 mild bleeding/anemia not requiring blood transfusion, 1 severe hemoperitoneum resulting in death. No perforations or sepsis were reported. Overall, minor complications represented 75% of all adverse events. No patient required urgent re-intervention due to treatment failure, and in selected cases repeat procedures were performed solely to complete EHL-guided lithotripsy or planned re-evaluation of biliary bening stenosis.

This pilot study demonstrates that percutaneous cholangioscopy, with or without a “rendezvous” approach, with the simultaneous presence of high professional figures like interventional radiologist and endoscopist, is feasible, effective, and generally safe for managing complex biliary conditions. DSOC enables a precise diagnosis in hard-to-reach areas both for diagnositc purposes or for targeted therapy, achieving successful stone clearance or stricture evaluation in challenging anatomies. The safety profile was acceptable considering the high-risk population (fragile/oncological patients), but the occurrence of 1 fatal adverse event should enfasize the need of performing this procedure in expert centers, where all facilities are available in a multidisciplinary setting, and by skilled operators able to interpret in real-time the intraductal findings to optimize the treatment strategy.