Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma

This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of recurrent hepatocellular carcinoma (HCC).

Study Overview

• Status: Completed
• Conditions: Recurrent Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: laparoscopic resection

Detailed Description

The investigators conducted a prospective study of 64 patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center from June 2014 to November 2014; 31 patients were enrolled in the laparoscopic group and underwent complete laparoscopic resection of HCC, and 33 patients were enrolled in the control group and underwent open surgical resection. The operation time, intraoperative blood loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain scores, postoperative time until the patient could walk, postoperative time until the patient could pass gas, hospital stay, and inpatient costs were compared between the two groups. The patients were followed up for one year after surgery, and the relapse-free survival was compared between the two groups.

• Study Type: Observational
• Enrollment (Actual): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center from June 2014 to November 2014

Description

Inclusion Criteria:

1. recurrent HCC after open surgery
2. recurrent HCC located in any part of the left lateral lobe or the diaphragm side of the right lobe and near the surface of the liver, which resulted in an easier operation
3. no significant surgical contraindications
4. no major vessel or bile duct tumor invasion and metastasis
5. grade A or B liver function or grade C liver function that recovered to grade A after liver-protective treatment;
6. the patient and his/her family was willing to undergo laparoscopic resection.

Exclusion Criteria:

1. major vessel or bile duct tumor invasion
2. recurrent HCC located in the right liver parenchyma and near secondary vessels and bile ducts, resulting in a difficult operation
3. grade C liver function
4. significant surgical contraindications
5. the patient and his/her family declined laparoscopic hepatectomy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laparoscopic group; patients in the laparoscopic group underwent laparoscopic resection of recurrent HCC	Procedure: laparoscopic resection; The surgical instruments used for the laparoscopic group included conventional laparoscopic instruments (three 5 mm trocars, two 10 mm trocars, and two damage-free laparoscopic clamps), the STORZ high-resolution laparoscopic operating system (Germany), the GEN300 ultrasonic scalpel system (Johnson & Johnson, USA), a laparoscopic linear cutter stapler (Johnson & Johnson, USA), a laparoscopic ultrasound device, LigaSure, bipolar coagulation, titanium laparoscopic clips, and absorbable hemostatic gauze.
control group; patients in the control group underwent conventional open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complications	The operation time, intraoperative blood loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain scores, postoperative time until the patient could walk, postoperative time until the patient could pass gas, hospital stay, and inpatient costs were compared between the two groups.	within the first 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relapse-free survival	The patients were followed up for one year after surgery, and the relapse-free survival was compared between the two groups.	1 year after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Li Xu, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 2, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; recurrence; laparoscopic
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Recurrence
• Other Study ID Numbers: B20140001