Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards (ADBoard)

Charité University Medicine Berlin

Status: Not yet enrolling

Conditions: Fibrolamellar Hepatocellular Carcinoma; Intrahepatic Cholangiocarcinoma; Hepatocellular Carcinoma; Gallbladder Carcinoma; Metastasis to Liver; Cholangiocarcinoma, Perihilar

Treatments: Other: ADBoard

Study type: Interventional

Funder types: Other

Identifiers

NCT05681949

EA4/169/22

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Participants' cases discussed in tumor conference without ADBoard

No Intervention group

Description:

Participants' cases are discussed in tumor conference without the use of ADBoard, according to conventional practice.

Participants' cases discussed in tumor conference with ADBoard

Experimental group

Description:

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

Treatment:

Other: ADBoard