Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma

NCT02613156 | Completed

• 1 other identifier: B20140001
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Recurrent Hepatocellular Carcinoma

Keywords

laparoscopic; hepatocellular carcinoma; recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• relapse-free survival

  1 year after surgery

Study Arms (2)

laparoscopic group

patients in the laparoscopic group underwent laparoscopic resection of recurrent HCC

Procedure: laparoscopic resection

control group

patients in the control group underwent conventional open surgery

Interventions

laparoscopic resection PROCEDURE

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.

laparoscopic group

Eligibility Criteria

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

You may qualify if:

• recurrent HCC after open surgery
• 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
• no significant surgical contraindications
• no major vessel or bile duct tumor invasion and metastasis
• grade A or B liver function or grade C liver function that recovered to grade A after liver-protective treatment;
• the patient and his/her family was willing to undergo laparoscopic resection.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Xu

  Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01