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PVE with coils proximally plus TAGM distally and subsequent major hepatectomy

PVE with multiple coils and subsequent major hepatectomy

PVE with TAGM distally and coils proximally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on future liver remnant (FLR) side for patients with pCCA when obstructive jaundice is present.

PVE with coils plus TAGM

Procedure: PVE with multiple coils PVE with multiple coils proximally and distally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on FLR side for patients with pCCA when obstructive jaundice is present.

PVE with multiple coils

Feng SHEN, MD, PhD

Bin YI, MD, PhD

Bin YI, MD

The aim of this study is to investigate the differences of safety and liver hypertrophy between portal vein embolization (PVE) using coils plus tris-acryl gelatin microspheres (TAGM) and multiple coils in patients with perihilar cholangiocarcinoma (pCCA) or with hepatocellular carcinoma (HCC).

Perihilar cholangiocarcinoma (pCCA) and hepatocellular carcinoma (HCC) both are common primary hepatobiliary tumors, which often require extensive hepatic resection and challenge perioperative management as surgery remains the only chance of long-term survival for such patients. PVE induces effective hypertrophy on one side of the liver parenchyma ahead of a planned liver resection of the other side which becomes atrophic.

Technically, the percutaneous transhepatic approach becomes the standard of care for PVE. PVEs themselves with different embolization materials could vary in the degree of liver hypertrophy, though some techniques, such as TAE, HVE and stem cell, have been already used in combination with PVE and could promote the hypertrophy. Several aspects on the use of PVE are insufficiently studied and most recommendations are based on low-grade evidence. Large clinical studies that compare the effect of different embolic materials on the hypertrophy response are lacking. PVE using multiple coils to completely occlude all the target segmental and sectional branches is a conventional and fundamental approach in our center, which ensured a reliable hypertrophy response with a low PVE-related morbidity and post-hepatectomy liver failure rate in the past decades. PVE using with tris-acryl gelatin microspheres (TAGM) distally and coils proximally, which needs more interventional experience, has become one of standard approaches in our center. However, the study of high-grade evidence regarding the hypertrophy effect of PVE with TAGM and coils is still lacking.

In this randomized study, the investigators aim to compare PVE using TAGM plus coils to PVE using coils alone, in term of PVE-related complications, hypertrophy degree, hepatectomy completion rate, post-hepatectomy liver failure rate, features of immunohistochemical examination on parenchyma, for patients stratified by either pCCA or HCC.

Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma

Preoperative Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma: a Randomized Controlled Study

The rate of major and minor PVE-related complications

The difference of standardized FLR ratios before and 2 weeks after PVE

The rate of completed major hepatectomy in each Arm group

The rate of liver failure measured by 50-50, TB peak 7mg, and ISGLS criteria

Immunohistochemical stainings of hypertrophic and atrophic parenchyma including anti-albumin, anti-PCNA, TUNEL staining, etc.

Eastern Hepatobiliary Surgery Hospital

Professor and Chief Surgeon, Principal Investigator

Anti-Inflammatory Agents

ABC294640

Mark L Levitt, MD, PhD

Vered Katz Ben-Yair, MSc

This is an expanded access program (EAP) for eligible participants who do not qualify for participation in, or who are otherwise unable to access, the ongoing clinical trial ABC-108. This program is designed to provide access to ABC294640 (Yeliva ®) for treatment of cholangiocarcinoma (CCA) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. An oncologist must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

Expanded Access to ABC-108, A Phase IIA Study of ABC294640 in the Treatment of Patients With Advanced,Unresectable Intra-hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma

RedHill Biopharma Limited

Three dimensional laparoscopic resection for pCCA

Open resection for pCCA

Hang Zhang, M.D.

Min Wang, Dr.

Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.

This is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. The trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is two years including prearrangement, follow-up and analyses.

Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma

Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.

Length of stay was defined as the postoperative time interval in days.

The drain bilirubin was monitored after surgery, any elevation for the bilirubin level or the diagnostic puncture proved bile fluid in abdominal cavity.

According to AJCC guideline, each patients TNM staging were recorded.

Complication Rate Measure Description Any complication mentioned in the protocol should be carefully record and analyzed, including postoperative hemorrhage, postoperative pancreatic fistula, etc.

Tongji Hospital

Clinical professor

Neoplasm Metastasis

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Fibrolamellar Carcinoma

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

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

Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors

ADBoard

Felix Krenzien

Christian Benzing

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.

The ADBoard study is a monocentric, prospective, parallel randomized controlled trial with a non-inferiority framework. Participants will be randomized 1:1 into one of two groups: either a) tumor conference with ADBoard, or b) tumor conference without ADBoard.

Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards

Evaluation of the Trustworthiness of the Application of Artificial Intelligence and Decision Support Systems for the Creation of Tumor Conference Protocols

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 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.

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.

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.

The time between the initial presentation of the case to the tumor conference and the time of recommendation implementation will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma	NCT04386772	Portal Vein Occ... Cholangiocarcin... Hepatocellular ... Liver; Hypertro...	PVE with coils ... PVE with multip...	18 Years - 70 Years	Eastern Hepatobiliary Surgery Hospital
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)	NCT03414489	Cholangiocarcin... Cholangiocarcin... Cholangiocarcin... Cholangiocarcin... Cholangiocarcin...	ABC294640	18 Years -	RedHill Biopharma Limited
Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma	NCT04386772	Portal Vein Occ... Cholangiocarcin... Hepatocellular ... Liver; Hypertro...	PVE with coils ... PVE with multip...	18 Years - 70 Years	Eastern Hepatobiliary Surgery Hospital
Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma	NCT03383796	Cholangiocarcin... Surgery	Three dimension... Open resection ...	18 Years - 75 Years	Tongji Hospital
Portal Vein Embolization Using Coils Plus TAGM vs Multiple Coils for Patients With Perihilar Cholangiocarcinoma or Hepatocellular Carcinoma	NCT04386772	Portal Vein Occ... Cholangiocarcin... Hepatocellular ... Liver; Hypertro...	PVE with coils ... PVE with multip...	18 Years - 70 Years	Eastern Hepatobiliary Surgery Hospital
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)	NCT03414489	Cholangiocarcin... Cholangiocarcin... Cholangiocarcin... Cholangiocarcin... Cholangiocarcin...	ABC294640	18 Years -	RedHill Biopharma Limited
Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards	NCT05681949	Hepatocellular ... Fibrolamellar H... Cholangiocarcin... Intrahepatic Ch... Metastasis to L... Gallbladder Car...	ADBoard	18 Years -	Charite University, Berlin, Germany
Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma	NCT03383796	Cholangiocarcin... Surgery	Three dimension... Open resection ...	18 Years - 75 Years	Tongji Hospital
Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards	NCT05681949	Hepatocellular ... Fibrolamellar H... Cholangiocarcin... Intrahepatic Ch... Metastasis to L... Gallbladder Car...	ADBoard	18 Years -	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for cholangiocarcinoma, perihilar