Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards

Not Applicable

Not yet recruiting

• Conditions: Hepatocellular Carcinoma; Fibrolamellar Hepatocellular Carcinoma; Cholangiocarcinoma, Perihilar; Metastasis to Liver; Intrahepatic Cholangiocarcinoma; Gallbladder Carcinoma
• Interventions: Other: ADBoard

• Registration Number: NCT05681949
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The goal of this observational study is to compare the recommendations of the artificial intelligence clinical decision support system 'ADBoard', with the recommendations of physicians by tumor conferences in patients with hepatobiliary tumors. The main questions it aims to answer are:

Can ADBoard achieve a high level of similar recommendations as physicians' tumor conferences? Can ADBoard consider a more complete set of patient-related data than in physicians' tumor conferences? Can ADBoard reduce the time between the first time the patient is discussed at the tumor conference and the start of the recommended treatment plan? Participants will have their hepatobiliary tumor treatments determined by either tumor conference with ADBoard, or tumor conference without ADBoard.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24
• Study Start: 2023-11
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Age ≥ 18 years
• Valid informed consent
• Patient information available in the hospital information system or Health Data Platform (HDP)
• Enrollment in the hepatobiliary tumor conference
• Diagnosis of any of the following entities: Colorectal liver metastasis, Gallbladder carcinoma, Hepatocellular carcinoma (HCC), mixed cell carcinoma, or fibrolamellar carcinoma, Perihilar cholangiocarcinoma (Klatskin tumors), Intrahepatic cholangiocarcinoma (iCC)

Exclusion Criteria

• Patient does not consent / incapable of giving consent
• Missing findings in the hospital information system
• Patient is seeking for a second opinion and is not being treated at the study institution

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants' cases discussed in tumor conference with ADBoard	ADBoard	Participants' cases will be evaluated by ADBoard directly before they are discussed in the tumor conference.

Primary Outcome Measures

Name	Time	Method
Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation	Through study completion, average of 30 months	Examples of possible treatment recommendations are liver resection (curative), regimen of chemotherapy, immunotherapy, radiotherapy, transarterial chemoembolisation, diagnostics, best-supportive care, follow-up by re-presentation.; The interrater reliability of the recommendations of ADBoard and the tumor conferences with regard to their agreement will be measured.
The reproducibility of the therapy recommendations made by ADBoard (yes/no)	Through study completion, average of 30 months	The intrarater reliability will be measured by testing all participant cases several times by the ADBoard according to the required sample size with sufficient statistical power (test-retest). Interrater and intrarater reliability will be evaluated descriptively (percentage of agreement, contingency tables), and finally the Cohen-Kappa value will be assessed.

Secondary Outcome Measures

Name	Time	Method
Completeness of the patient information with regard to decision-relevant parameters	Through study completion, average of 30 months	For each type of tumor examined, a series of relevant parameters is defined by the medical staff. The objective is achieved if complete documentation, defined as documentation status 'present' or 'detected as missing', is present in more than or equal to 75% of all ADBoard-assisted decisions.
Quality of the explainability of the tumor conference protocols (ADBoard)	Through study completion, average of 30 months	The System Causability Scale will be reviewed by 3 specialist physicians. The score ranges from 0 to 1. A higher score means greater suitability of the user interface, explanation, or explanation process itself for the intended purpose of tumor conference treatment recommendations.
Time between primary presentation and start of diagnostics/therapy as recommended	Through study completion, average of 30 months	The time between the initial presentation of the case to the tumor conference and the time of recommendation implementation will be recorded.

Trial Locations

Locations (1)

Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany