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Completed

NCT Number: NCT02613156

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Perioperative complications

    Time frame: within the first 30 days

    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.

Secondary outcomes

  1. relapse-free survival

    Time frame: 1 year after surgery

    The patients were followed up for one year after surgery, and the relapse-free survival was compared between the two groups.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2015
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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