Background and study aims: We have previously developed duodenal balloon-assisted direct cholangioscopy (DBA-DC)
with an ultrathin endoscope (UTE). Here, we further evaluated the feasibility, safety,
and diagnostic and therapeutic usefulness of DBA-DC using UTE.
Patients and methods: 40 consecutive patients with biliary diseases were enrolled in a prospective observational
feasibility study. We assessed the success rate, procedure time, durability of the
UTE, and usefulness in diagnosis and therapy. We also evaluated safety, including
cardiovascular alterations and biliary injury as complications of the procedure.
Results: DBA-DC was performed successfully in 37/40 patients (92.5 %). The mean time to reach
either biliary bifurcation or stricture was 11.8 ± 6.3 minutes. The procedure revealed
26 biliary stones, 5 cholangiocarcinomas, and 3 benign biliary strictures. Therapeutic
procedures were performed in 16 patients (10 biliary lithotomies, 3 holmium-YAG laser
lithotripsies, and 3 intraductal stent placements). No significant clinical complications
related to DBA-DC were observed. Changes in cardiovascular responses and biliary biochemical
parameters were minimal, except for leukocytosis in 8 patients.
Conclusions: DBA-DC appears to be sufficiently feasible and may be useful as an alternative technique
in cases that elude successful diagnosis and/or therapy with conventional endoscopic
retrograde cholangiopancreatography (ERCP).