Laparoscopic Versus Open Major Hepatectomy for HCC Hepatectomy for Hepatocellular Carcinoma

NCT04852211 | Unknown DMC

• 1 other identifier: 002kkcng/surg/cuhk
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To compare the long-term oncological outcome between laparoscopic and open major hepatectomy for patients with hepatocellular carcinoma
2. 2.To achieve the comparison under the study design of multi-center randomized trial involving 5 high-volume centers in Asia-Pacific region
3. 3.Primary outcome is 2-year recurrence-free survival.
4. 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. 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
6. 6.Department of Surgery, The Chinese University of Hong Kong
7. 7.Department of Surgery, Kwong Wah Hospital, Hong Kong
8. 8.Department of Surgery, West China Medical School of Sichuan University
9. 9.Department of Biliary Surgery, Eastern Hepatobiliary Surgery Hospital \& Institute, Second Military Medical University
10. 10.Department of Surgery, The First People's Hospital of Foshan
11. 11.Laparoscopic group: LMH
12. 12.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.

Conditions

Hepatocellular Carcinoma

Keywords

Laparoscopic surgery; Open Surgery; Major hepatectomy; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence-free survival

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

  2 years

Secondary Outcomes (4)

• Hospital mortality

  1 year

• Morbidity

  1 year

• Quality of llife

  1 year

• 5 - year Overall survival

  5 years

Study Arms (2)

Open major hepatectomy

ACTIVE COMPARATOR

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

Procedure: Open or laparoscopic surgery

Laparoscopic major hepatectomy

ACTIVE COMPARATOR

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

Procedure: Open or laparoscopic surgery

Interventions

Open or laparoscopic surgery PROCEDURE

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

Laparoscopic major hepatectomy; Open major hepatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HCC is in accordance to the diagnostic criteria for HCC used by the European Association for the Study of the Liver. HCC was diagnosed when the radiologic imaging techniques (spiral contrasted CT scan or contrasted MRI) showed typical features of HCC (contrast enhancement in the arterial phase and rapid wash-out of contrast in the venous or delayed phase) and/or elevated serum alpha fetoprotein (AFP) level.
• HCC of maximum diameter up to 10 cm; Single or multiple tumor nodules confined to one liver lobe according to the previous reported series
• Major hepatectomy (resection of \> 3 Couinaud's segments) is required as judged by hepatobiliary surgeons
• Absence of extrahepatic metastasis or radiological evidence of venous invasion of major portal vein or hepatic vein branches
• Child's A liver function
• Indocyanine green retention at 15 min (ICG-15) \< 15%
• Adequate future liver remnant (image-guided volumetry \> 35% of estimated standard liver volume)
• General condition fit for general anaesthesia

You may not qualify if:

• Tumors unfavorable for major hepatectomy (e.g. bilobar tumors, main portal vein tumor thrombus and/or inadequate future liver volume)
• Previous treatment for HCC (e.g. transarterial chemoembolization, or chemotherapy)
• Tumors require combined hepatectomy and thermal ablation therapy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Health and Medicine Research Fund: collaborator

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Kelvin.K.C Ng, MS, PhD

CONTACT

+852 9124 2695; kelvinng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 21, 2021
• Study Start: December 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)