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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

Recurrence

Disease Attributes

Major hepatectomy was defined as the removal of four or more Couinaud's liver segments.

Minor hepatectomy was defined as the removal of three or fewer Couinaud's segments.

Major hepatectomy

Dalong Yin, Ph.D

Hepatectomy is the first option for the treatment of hepatocellular carcinoma(HCC) at CNLC Ib stage. HCC patients who undergo curative hepatectomy may experience varying remnant liver volumes and thus leads to different oncological outcomes.

Patients with hepatocellular carcinoma (HCC) who undergo curative hepatectomy may experience varying remnant liver volumes. The investigators aimed to evaluate whether the extent of liver resection has an effect on postoperative recurrence in HCC patients. A retrospective analysis was conducted on 197 patients who underwent hepatectomy for a solitary HCC lesion measuring ≥5 cm between January 2019 and June 2022. Patients were divided into major hepatectomy (MAH) group (n=70) and minor hepatectomy (MIH) group (n=127) based on the extent of liver resection. Recurrence-free survival (RFS) was compared between the two groups. Propensity score matching was employed to mitigate potential biases in this research.

Impact of Hepatectomy on HCC Recurrence

Impact of Major Hepatectomy on Recurrence After Resection of Hepatocellular Carcinoma at China Liver Cancer Staging (CNLC) Stage : a Propensity Score Matching Study

the time from the time of radical surgery to the time of HCC recurrence

National Natural Science Foundation of China

Anhui Medical University

Clinical Professor

Neoplasm Metastasis

Liver Failure

Hepatic Insufficiency

Micronutrients

Iron

Participants will be recruited after they have been diagnosed and their treatment has been planned by a multidisciplinary tumor board. Patients indicated to undergo major liver resection (\> 3 segments based on Brisbane classification \[23\]) will be eligible for participation.

MRI scans will be performed at the Champalimaud Foundation using a 1.5T scanner after patients have fasted for 4 hours. Transverse abdominal T1 maps will be acquired to estimate extracellular fluid (which increases in cases of fibrosis and inflammation) and T2\* maps will be acquired to estimate liver iron levels. These quantitative MRI maps will be laid onto the volumetric images of Couinaud segments. Multi-slice quantitative maps will be generated using Liver MultiScan software (Perspectum, UK) with operators blinded to patient status. T1 measurements will be adjusted for the iron level to give iron-corrected T1 maps (cT1). Reference ranges for cT1 have been defined in the general population. PDFF maps of the liver will be calculated using MRI multi-echo and spoiled-gradient-echo acquisition. No intravenous contrast agents will be used in Liver MultiScan maps and the total scan duration will be approximately 30 minutes.

Multiparametric MRI scan of the liver

Arianeb Mehrabi, Professor

The present observational study aims to assess the benefit of this quantitative multiparametric magnetic resonance imaging (MRI) in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy, among patients undergoing major liver resection.

The main questions to be answered are:

* Can multiparametric MRI predict the postoperative liver function?
* Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality? With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power.

In patients being considered for major liver resection, volumetric and functional evaluation of the future liver remnant should ideally be combined to reduce the risk of posthepatectomy liver failure (PHLF) and other adverse outcomes. Quantitative multiparametric magnetic resonance imaging (MRI) can measure liver health by assessing parenchyma fibrosis and inflammation. This has shown promising results in predicting postoperative liver performance. The current study aims to assess the benefit of this MRI-based technology in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy.

Prospective observational clinical study in a single hepatobiliary surgery center. With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. Postoperative liver function and complications will be reported for 90 days after surgery. Preoperative MRI assessment scores and postoperative outcomes will be correlated to determine whether multiparametric MRI scans can accurately predict the risk of postoperative liver-specific complications (primary endpoint) as well as postoperative liver function, surgery-specific complications, the overall complication rate, quality of hospital care, and length of stay. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power. This study will include 33 patients and results are expected in 2024. If successful, this investigation will support the use of quantitative multiparametric MRI to guide surgical decision-making. This will represent a non-invasive, diagnostic, volumetric, and segmental functional test for the preoperative workup of patients being considered for major hepatectomy.

Quantitative MRI and Outcomes of Liver Resection

Predicting the Outcomes of LIVEr Resection Using Quantitative Magnetic Resonance Imaging: the POLIVER Study

Upon reasonable request, the data generated by the current research that supports our future article, would be made available as soon as possible, wherever legally and ethically possible.

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy liver failure after major liver resection

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy biliary leakage after major liver resection

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy hemorrhage after major liver resection

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and major complications according to Clavien-Dindo classification (\>IIIA) after major liver resection

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and mortality according to Clavien-Dindo classification (\>IIIA) after major liver resection

Fundacao Champalimaud

University Hospital Heidelberg

Professor Dr. med.

Resection of the tumor together with 3 or more liver segments using open standard techniques of hepatectomy

Resection of the tumor together with 3 or more liver segments using minimally invasive techniques of hepatectomy

Patients, with their consent, will be recruited to participate by investigators after considering the inclusion and exclusion criteria. Treatment allocation to the eligible patients will follow a randomization schedule. A total of 212 subjects will be randomized 1:1 to one of the two treatment arms:

1. Laparoscopic group: LMH
2. Open group: OMH

Open or laparoscopic surgery

Kelvin.K.C Ng, MS, PhD

Kelvin K.C. Ng, MS, PhD

Background: Hepatocellular carcinoma (HCC) is the sixth most common malignancy in the world. Major hepatectomy (resection of \> 3 liver segments) is needed if tumor is close to major blood vessels within liver. Despite low mortality, open major hepatectomy (OMH) is associated with high tumor recurrence rate, and short survival. Immunosuppression due to surgical stress and blood transfusion, and dissemination of tumor cells because of tumor manipulation all contribute to tumor recurrence.

Laparoscopic major hepatectomy (LMH) is a newly developed minimally invasive technique for HCC. Apart from less wound problems and shorter recovery time than open surgery, LMH may have potential oncological benefits of prolonging survival. These could be related to the reduced intraoperative blood loss, less immunosuppression due to surgical stress, and less tumor manipulation. Hence, LMH could be a better treatment option than OMH for HCC.

Objectives:

1. To compare the long-term oncological outcome between laparoscopic and open major hepatectomy for patients with hepatocellular carcinoma
2. To achieve the comparison under the study design of multi-center randomized trial involving 5 high-volume centers in Asia-Pacific region
3. Primary outcome is 2-year recurrence-free survival.
4. Secondary outcome as intraoperative blood loss, blood transfusion, 30-day and hospital mortality, postoperative morbidities according Clavien-Dindo classification, hospital stay, quality of life, overall and recurrence-free survival rates up to 5 years after surgery
5. To compare the perioperative changes in stress-related cytokines, which help to clarify the stress response and immunosuppression and their correlations with overall and recurrence-free survival rates

Hypothesis: Laparoscopic major hepatectomy is associated with less surgical stress, less immunosuppression and thus less tumor recurrence and better survival than open major hepatectomy.

Study design: This is an open-labelled prospective randomized trial involving 106 patients in each treatment arm (Total number of patients recruited: 212). The study will involve 5 surgery centers in Asia-Pacific region (2 centers in Hong Kong, 3 centers in Mainland China Foshan, Shanghai and Sichuan).

Subjects: Patients with HCC undergone major hepatectomy. Recruitment centres involved:

1. Department of Surgery, The Chinese University of Hong Kong
2. Department of Surgery, Kwong Wah Hospital, Hong Kong
3. Department of Surgery, West China Medical School of Sichuan University
4. Department of Biliary Surgery, Eastern Hepatobiliary Surgery Hospital \& Institute, Second Military Medical University
5. Department of Surgery, The First People's Hospital of Foshan

Intervention: Consented patient will be randomized 1:1 to one of the two treatment arms:

1. Laparoscopic group: LMH
2. Open group: OMH The randomization schedule will be generated by the Clinical Trials Centre (CTC) of principle investigator's center, prior to the start of the study.

Main outcome measure: The primary objective is to test the hypothesis that LMH is associated with less surgical stress, less immunosuppression and thus less tumor recurrence and better survival than OMH. The primary outcome measure is 2-year recurrence-free survival.

Data analysis: Statistical plan and data monitoring Statistical analysis will be performed using SPSS version 11.0 (SPSS Inc., Chicago, Ill). The 2-year recurrence-free survival (primary outcome) will be evaluated by Kaplan-Meier method and compared by the log-rank test between studied groups.

Expected results: The result of this study provides level 1 evidence on the best treatment option for HCC, which needs major hepatectomy. Such information will influence the evidence-based policy in professional practice in the management algorithm for HCC. Since postoperative complications and tumor recurrence are substantial after OMH, potential benefits of LMH tested in this study will help to alleviate these problems.

Background: Hepatocellular carcinoma (HCC) is the sixth most common malignancy in the world.The practice of screening by ultrasonography and serum alpha-fetoprotein concentration in cirrhotic patients and hepatitis B carriers has led to an increasing incidence of HCC.

Hepatectomy, local ablation and liver transplantation are regarded as the mainstay of curative treatment for HCC according to international guidelines by EASL, AASLD and ESMO.The shortage of liver grafts has limited the application of liver transplantation. Hepatectomy is thus widely accepted as the treatment option of choice for patients with HCC and non cirrhotic liver.

Major hepatectomy (resection of \> 3 Couinaud's segments) is always needed when HCC is large or is close to major blood vessels within liver. With the advancements in techniques of hepatectomy and perioperative patient care, the operative mortality of open major hepatectomy (OMH) has reduced to \< 5% in recent years. Nonetheless, OMH for HCC is still associated with major problems as follows:

1. It is associated with significant morbidities. The morbidity rate after OMH remains high (30% - 40%) even in high-volume centres. Wound infection and bronchopneumonia are among the most common complications after hepatic resection. Long incision and vigorous retraction of the rib cage are required to achieve adequate exposure of the liver tumor during hepatic resection. As a result, sepsis due to chest complications and wound problems are frequently encountered. Furthermore, division of the porto-systemic collaterals in the anterior abdominal wall contributes to postoperative ascites, which is another common complication.
2. It is associated with a high tumor recurrence rate, even when performed with a curative intent. The 3-year recurrence rate has been reported to be more than 50%. Most recurrences occur in the liver remnant, in the forms of intrahepatic metastasis or multicentric tumor recurrence. Risk factors related to recurrence include unfavorable tumor factors such as microscopic venous or capsular invasion. Hence, tumor cell dissemination could be the main mechanism of recurrence. In this context, manipulation of the tumor during OMH leading to tumor cell dissemination can potentially contribute to high tumor recurrence rate. Furthermore, it has been suggested that postoperative immunosuppression induced by surgical stress may induce tumor growth in the liver remnant.

Laparoscopy has a well-defined role in the staging and diagnosis of hepatobiliary malignancies. However, laparoscopic hepatectomy has not yet been widely practiced, because of the technical difficulties in liver resection, difficulty in the control of hemorrhage during liver transection and retraction of the liver for optimum exposure. With the advanced laparoscopic techniques, much enthusiasm has been developed in laparoscopic major hepatectomy (LMH). Recent series have proven the feasibility and safety of LMH for HCC. The selection criteria of the reported series included tumor size up to 10cm and single or multiple tumors confined to one liver lobe. The overall conversion rates was around 10%. There was no hospital mortality and the morbidity rate was about 10%. Apart from the documented advantages of laparoscopic surgery (less wound and chest complications, and shorter hospital stay), theoretically, LMH carries oncological advantages over OMH. LMH may result in less surgical stress and immunosuppression due to less intraoperative blood loss than OMH. Moreover, using laparoscopic instruments, it involves minimal manipulation of the tumor and less cancer cells dissemination during surgery. Potentially, postoperative tumor recurrence could be reduced and hence patient survival could be prolonged.

To date, only retrospective studies using propensity score matching to compare LMH with OMH were reported. In these study, the studied patient number was small (\< 40) in each matched treatment arm and the reported 2-year overall (86% - 88% vs. 85% - 100%) and recurrence-free survival (72% - 83% vs. 81% - 85%) rates were comparable between OMH and LMH. Nevertheless, there is a trend that LMH is associated with better overall and recurrence-free survival than OMH. It is likely that these studies were underpowered (Type II error) to show the potential oncological benefits of LMH over OMH. Because of these limited data on LMH, according to EASL, AASLD and ESMO guidelines, its role for HCC is still not yet defined. In the sphere of laparoscopic hepatectomy, according to the European Guideline Meeting for Laparoscopic Liver Surgery (Southampton consensus), there was only limited data on short-term outcome but no data on long-term outcome of LMH. With these reasons, there is an urge for a prospective study aiming to define the role of LMH for HCC with respect to its potential oncological benefits.

In the principle investigator's institution (the Department of Surgery, The Chinese University of Hong Kong), preliminary data using propensity score matching analysis on patients with HCC (median size = 4cm) undergone either laparoscopic (n = 112) or open hepatectomy (n = 224) (major hepatectomy accounts for 40.5%), the intraoperative blood loss (median: 159 mL vs. 419 mL), blood transfusion rate (0% vs. 4.5%) and morbidity rate (5.4% vs. 28.1%) were significantly lower in laparoscopic group than open group. The hospital mortality (0% vs. 0.4%), long-term overall (5-year: 56% vs. 42%) and recurrence free (5-year: 36% vs. 33%) survival rates were comparable between groups. (Supplementary information attached) With this experience, the principle investigator proposes an open labelled prospective multi-center randomized trial (AP-LAPO Trial) comparing LMH with OMH for HCC. This study involves 5 high-volume centres specialized in liver surgery and with facilities supporting LMH and OMH in Asia-Pacific region (Hong Kong, Sichuan, Guangzhou and Foshan). These centres perform at least 30 LMH or OMH per year (The Chinese University of Hong Kong, median no. = 51; Kwong Wah Hospital, median no. = 30; West China Medical School of Sichuan University, median no. 120; Eastern Hepatobiliary Surgery Hospital \& Institute, median no. = 115; The First People's Hospital of Foshan, median no. = 102), and have achieved excellent perioperative and oncological outcome after LMH or OMH (operative mortality 1% - 2%; complication rate 14% - 23%; 2-year overall survival rate 85% - 88%; 2-year disease-free survival rate 81% - 84%).

Objectives and hypothesis: The primary objective is to test the hypothesis that LMH is associated with less surgical stress, less immunosuppression and thus less tumor recurrence and better survival than OMH. The primary outcome measure is 2-year recurrence-free survival. The secondary outcome measures include hospital mortality, morbidity, quality of life and overall survival between groups. Besides, stress-related cytokines (interleukin-6 \[IL-6\] and immunosuppressive acidic protein\[IAP\]) will also be measured during the perioperative

Sample size estimation: Based on a reported 2-year recurrence-free survival rate of 72% after OMH and an expected 88% after LMH (about 20% improvement) according to a previously reported series, 106 patients need to be recruited to each arm in order to demonstrate a statistically significant difference with a 80% power at the 0.05 level of 2-sided significant difference between laparoscopic and open hepatic resection, allowing a drop-out rate of 10%. This sample size will also allow detection of reduction of 2-year tumor recurrence from 50% in OMH group to 30% in LMH with a similar power and level of significance. The principle investigator's unit is a major referral center for management of HCC in Hong Kong, with more than 150 new cases seen per year. There are one other centers in Hong Kong and 3 centers in Mainland China, which are specialized in both laparoscopic and open surgery for patients with HCC, with referral patient number ranging from 50 to 200 per year. The planned number of patients recruited in each participating centres is as follows (The Chinese University of Hong Kong, N = 32; Kwong Wah Hospital, N = 20; West China Medical School of Sichuan University, N = 50; Eastern Hepatobiliary Surgery Hospital \& Institute, N = 50; The First People's Hospital of Foshan, median no. = 60) It is therefore expected that recruitment can be completed in about 12 months. All patients will be observed for at least 24 months after treatment. Hence, the total period of study including follow-up is estimated to be about 3 years for the funding period. After the funding period, recruited patients will be followed up periodically up to 5 years after surgery to evaluate the long-term outcome.

Statistical analysis: Statistical analysis will be performed using SPSS version 11.0 (SPSS Inc., Chicago, Ill). The 2-year recurrence-free survival (primary outcome) will be evaluated by Kaplan-Meier method and compared by the log-rank test between studied groups.

Other secondary outcome measures will be compared using Chi-squared test or Fisher's exact test for categorical variables, and Mann-Whitney U test for continuous variables between groups. Overall survival is again computed by the Kaplan-Meier method and compared by the log-rank test between groups. P \< 0.05 is considered statistically significant.

Ethical consideration: All aspects of the study will be discussed with each subject during a phone interview or screening visit. An information sheet will be provided, and each subject will be given the opportunity to seek medical advice or to discuss the study with friends or family prior to involvement. Each volunteer will give written, informed consent, in accordance with the attached form, and the subjects will be free to withdraw from the study at any time. This study will be performed in accordance with the ethical standards of the Declaration of Helsinki of 1975 and its later versions. Ethics approval from the institutional review broad of individual center will be sought.

Relevance to clinical applications: The proposed study is an open-labelled prospective multi-center randomized trial investigating the potential benefits of laparoscopic major hepatectomy for hepatocellular carcinoma (HCC), as compared to conventional open surgery. It involves 5 high-volume surgery centers in the Asia-Pacific region, where the incidence of hepatocellular carcinoma is high. The result of this study provides level 1 evidence on the best treatment option for HCC, which needs major hepatectomy. Such information will influence the evidence-based policy in professional practice in the management algorithm for HCC. Since postoperative complications and tumor recurrence are substantial after OMH, potential benefits of LMH tested in this study will help to alleviate these problems. Ultimately, the long-term survival of patients with HCC could be improved.

Patients with hepatocellular carcinoma which undergone major hepatectomy will be randomized to either laparoscopic or open surgery group

Laparoscopic Versus Open Major Hepatectomy for HCC Hepatectomy for Hepatocellular Carcinoma

Asia-Pacific Multi-Centre Randomized Trial of Laparoscopic Versus Open Major Hepatectomy for Hepatocellular Carcinoma (AP-LAPO Trial)

The proportion of patients surviving without tumor recurrence as measured by postoperative images (CT or MRI) at 2 years

Death of patient after index surgery within same hospital admission

Complications of surgery as defined by Clavien-Dindo classification

Quality of life assessment by Functional Assessment of Cancer Therapy - General questionnaire (Score 0 - 108); high score means good performance status and vice versa

Overall survival of patients after surgery at 5 years after surgery

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
Impact of Hepatectomy on HCC Recurrence	NCT06390228	Hepatocellular ... Recurrence	Major hepatecto...	18 Years - 85 Years	Anhui Medical University
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
Quantitative MRI and Outcomes of Liver Resection	NCT06181318	Liver Cancer Liver Failure Bile Leak Liver Metastase...	Multiparametric...	18 Years -	University Hospital Heidelberg
Laparoscopic Versus Open Major Hepatectomy for HCC Hepatectomy for Hepatocellular Carcinoma	NCT04852211	Hepatocellular ...	Open or laparos...	18 Years -	Chinese University of Hong Kong
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

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