Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

NCT01768741 | Unknown

• 1 other identifier: SRRSH20121225-2
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the clinical value of laparoscopic liver resection in the treatment of hepatocellular carcinoma by assessing its Surgical and oncologic outcomes comparing with open liver resection.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Total survival time and disease free survival time

  up to 5 years

Secondary Outcomes (8)

• Surgical margins

  7 days

• Time to functional recovery

  participants will be followed for the duration of hospital stay, an expected average of 6 days

• Postoperative hospital stay

  participants will be followed for the duration of hospital stay, an expected average of 7 days

• Morbidity and mortality

  up to 3 months

• Quality of life

  up to 1 year

Other Outcomes (1)

• Hospital costs

  participants will be followed for the duration of hospital stay, an expected average of 9 days

Study Arms (2)

Laparoscopic liver resection group

ACTIVE COMPARATOR

Procedure: Laparoscopic liver resection

Open liver resection

ACTIVE COMPARATOR

Procedure: Open liver resection

Interventions

Laparoscopic liver resection PROCEDURE

participants will be performed with laparoscopic hepatectomy using laparoscopic instruments

Also known as: Laparoscopic hepatectomy

Laparoscopic liver resection group

Open liver resection PROCEDURE

participants will be performed with open hepatectomy using laparotomic instruments

Also known as: Open hepatectomy

Open liver resection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver solid tumor, with clinical diagnosis of hepatocellular carcinoma
• Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
• The tumor location and size do not affect the dissection of hepatic hilar region
• Tumor size less than 10cm
• Without portal vein tumor thrombus
• Without intrahepatic or distant metastasis
• Willingness to participate in the study
• Able to understand the nature of the study and what will be required of them
• Body mass index of between 18 and 35
• Child-Pugh classification of A to B
• American Society of Anesthesiologists (ASA) grading of I to III

You may not qualify if:

• Pregnant or lactating women
• Unwillingness to participate
• Inability to give written informed consent
• Child-Pugh classification of C
• ASA grading of IV to V
• Tumor invasion of the inferior vena cava or confluence part of hepatic vein
• Decompensated liver cirrhosis

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Xiujun Cai, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiujun Cai, MD

CONTACT

0086-0571-86006605; caixiujunzju@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice-President

Study Record Dates

• First Submitted: January 13, 2013
• First Posted: January 15, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2021
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CN (1)