Optimizing Outcomes of Single-Operator Cholangioscopy-Guided Biopsies Based on a Randomized Trial

Area of Science:

• Gastroenterology
• Hepatology
• Endoscopic Diagnostics

Background:

• Single-operator cholangioscopy is the most sensitive method for tissue acquisition in indeterminate bile duct strictures (IBDS).
• Optimizing specimen collection and processing is essential for accurate diagnosis.
• Current methods require refinement for improved diagnostic yield.

Purpose of the Study:

• To determine the optimal method for specimen processing in IBDS.
• To identify the number of biopsies required for a definitive diagnosis.

Main Methods:

• A prospective comparative study randomly assigned patients with IBDS to onsite (n=32) or offsite (n=30) specimen processing.
• Primary outcome: compare operating characteristics of onsite vs. offsite processing.
• Secondary outcome: determine the number of biopsies needed for definitive diagnosis.

Main Results:

• No significant differences in diagnostic accuracy (90% vs 87.5%), sensitivity (76.9% vs 75%), specificity (100%), PPV (100%), or NPV (85% vs 80%) between onsite and offsite groups.
• Diagnostic accuracy was 90% for both groups, irrespective of 3 or 4 biopsies collected in the offsite cohort.
• A median of 1 biopsy was sufficient for diagnosis in the onsite cohort.

Conclusions:

• Offsite processing of 3 single-operator cholangioscopy-guided biopsies achieves 90% diagnostic accuracy for biliary strictures.
• This accuracy is comparable to onsite processing, even without onsite cytopathology support.
• The study provides evidence for optimizing specimen processing in centers without immediate cytopathology services.