Clinical trial NCT05374122: AI Guidance for Biopsy in Suspected Cholangiocarcinoma
Official title: Efficacy of Artificial Intelligence Aid-digital Single-operator Cholangioscopy (DSOC) Guided-biopsy Sampling in Suspected Cholangiocarcinoma: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Non-Neoplastic
Bile Duct Neoplasms
Bile Duct Lesions
Keywords: Artificial Intelligence
Cholangioscopy
cholangiocarcinoma
biopsy
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: DIAGNOSTIC

Brief summary: Digital single-operator cholangioscopy (DSOC) has emerged as a medical advance with an important role in the evaluation of indeterminate biliary lesions. This technique has demonstrated higher sensitivity in the guidance for tissue acquisition when compared with standard endoscopic retrograde cholangiopancreatography (ERCP). DSOC-guided biopsy is considered technically safe and successful for tissue collection.

Hand in hand with the development of more precise diagnostic techniques, comes the implementation of artificial intelligence (AI) for diagnostic assessment. For the past decade, the role of artificial intelligence (AI) has been increasing at a rapid pace. In the biliary tract, different models have been proposed for the characterization of malignant features. Nevertheless, to date, the discrepancy between the visual impression of the operator and the histological results obtained by cholangioscopy still present, affecting the accuracy the diagnosis.

Based on the above, the investigators aim to assess the diagnostic accuracy of AI for the guidance of tissue acquisition with DSOC compared to DSOC without AI for suspected cholangiocarcinoma. As a secondary aim, the investigators pursue to compare quality of AI-guided biopsies samples vs. DSOC biopsies without AI.

Detailed description: The diagnosis and management of biliary malignancy currently represents a medical challenge. To date, DSOC has demonstrated high sensitivity in the detection of malignant biliary lesions, nevertheless there is not a universal expert consensus for the characterization of this lesions. Also, DSOC has shown to be safe and successful for specimen collection with higher sensitivity when compared with standard ERCP.

Moreover, most of the AI models proposed for characterization of neoplastic features in biliary lesions have demonstrated high reliability during DSOC performance. A model was the proposed by investigators in Ecuador, focused on the identification of features of malignancy. The detection is performed by surrounding the suspected lesion in a bounding box. The detected area is displayed in the right side of the screen. Also, the box/image of the presumptive lesion can also be recorded and reviewed afterwards. After the AI model detects the "malignant area", a tissue sample is collected and taken for histopathological studies.

In addition, due to a variation of the endoscopists´ intra and interobserver agreement and the discrepancy between the visual impression and histopathological findings, the investigators intend to take advantage of our AI model as a diagnostic tool for a more precise acquisition of tissue in lesions suggestive of malignancy during real-time DSOC.

Eligibility criteria: Inclusion Criteria:

* Patients referred to our center with an indication of DSOC due to suspicion of CBD tumor or indeterminate CBD stenosis.
* Patients who authorized for DSOC-guided biopsy.

Exclusion Criteria:

* Any clinical condition which makes DSOC inviable.
* Patients with more than one DSOC.
* Lost on a six-month follow-up after DSOC.

Primary outcomes:
measure: Cholangiocarcinoma diagnosis confirmation after biopsy and six-month follow-up
timeFrame: Six months
Secondary outcomes:
measure: Insufficient biopsy sample rate
timeFrame: Six months
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Carlos Robles-Medranda
state: Guayas
Study officials:
affiliation: Ecuadorian Institute of Digestive Diseases
name: Carlos Robles-Medranda, MD FASGE
role: PRINCIPAL_INVESTIGATOR
References:
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