A clinical trial has been launched to assess the diagnostic accuracy of artificial intelligence to guide tissue acquisition with digital single-operator cholangioscopy for suspected cholangiocarcinoma. The study also aims to compare the quality of the biopsies acquired with those obtained without the guidance of artificial intelligence.

The open-label, interventional, parallel-assignment, randomized-controlled trial is taking place in Ecuador and includes 48 participants, aged 18 to 99 years, who were referred to Instituto Ecuatoriano de Enfermedades Digestivas for digital single-operator cholangioscopy due to suspicion of common bile duct tumor or indeterminate common bile duct stenosis.

During the trial, participants will be divided into 2 groups. The first will be composed of participants with suggestive malignant biliary lesions as assessed by digital single-operator cholangioscopy for biopsy. A complement tool and artificial intelligence model will be used to detect features suggestive of malignancy to perform the biopsy. In the second group, digital single-operator cholangioscopy without the guidance of artificial intelligence will be used.

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The primary outcome measure of the study is the confirmation of a cholangiocarcinoma diagnosis after the biopsy and at the 6-month follow-up. The secondary outcome measure is the rate of insufficient samples in each group.

Read more about the diagnosis of cholangiocarcinoma

The estimated completion date of the trial is December 30, 2022.

Digital single-operator cholangioscopy is a new medical advance that can be used to evaluate indeterminate biliary lesions. It is a safe and successful technique that is more sensitive than standard endoscopic retrograde cholangiopancreatography for guiding tissue acquisition.

Artificial intelligence has emerged as a tool for diagnostic assessment as more precise diagnostic techniques are being developed. Most artificial intelligence models proposed to characterize neoplastic features in biliary lesions have been shown to be highly reliable during digital single-operator cholangioscopy. 


AI guidance for biopsy in suspected cholangiocarcinoma. ClinicalTrials.gov. May 16, 2022. Accessed May 18, 2022.