AI Guidance for Biopsy in Suspected Cholangiocarcinoma

March 3, 2023 updated by: Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas

Efficacy of Artificial Intelligence Aid-digital Single-operator Cholangioscopy (DSOC) Guided-biopsy Sampling in Suspected Cholangiocarcinoma: A Prospective, Randomized Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505
        • Carlos Robles-Medranda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DSOC + AI-biopsy guidance

This group is comprised by patients with suggestive malignant biliary lesions assessed by DSOC for biopsy. In this group, the investigators aim to use as a complement tool an AI model for the detection of features suggestive of malignancy to perform the biopsy on the detecting bounding box signal.

A further follow-up of 6 months is necessary for a confirming diagnosis of neoplastic lesions.
Diagnostic test: DSOC with AI biopsy guidance
Patients with a presumptive diagnosis of biliary malignancy will undergo DSOC + Artificial intelligence model (AIWorks) guidance for detection of neoplastic lesion during real-time procedure, tissue sampling acquisition, and histopathological analysis.
Active Comparator: DSOC biopsy without AI guidance
This group is comprised by patients with suggestive malignant biliary lesions assessed by DSOC for biopsy without AI guidance. A further follow-up of 6 months is necessary for a confirming diagnosis of neoplastic lesions.
Diagnostic test: DSOC biopsy without AI guidance

Patients with lesions suggestive of malignancy will undergo DSOC without AI guidance for sampling.

Based on the observer´s criteria regarding areas suggestive of malignancy, the collected tissue sample will be sent for histopathological studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholangiocarcinoma diagnosis confirmation after biopsy and six-month follow-up
Time Frame: Six months

To confirm the diagnosis based on pathology results from specimens obtained through DSOC (with or without AI-guided biopsy) or findings from further indicated procedures, including brush cytology fluoroscopy-guided biopsy, endoscopic ultrasound-guided tissue sampling, and surgical samples.

Finally, the gold standard is a six-month follow-up compared against the AI model (group 1) or the DSOC endoscopist experts' classification. The data will be verified through a 2 x 2 contingency table.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insufficient biopsy sample rate
Time Frame: Six months
Four biopsies will be performed per each case. Rate of insufficient samples by each study group will be recorded and compared.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECED-05052022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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