Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma

Recurrent Hepatocellular Carcinoma Clinical Trial

Official title:

Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613156
• Other study ID #: B20140001
• Status: Completed
• Phase: N/A
• First received: November 20, 2015
• Last updated: January 2, 2016
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Recurrent Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No