Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma

NCT ID: NCT02613156

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

laparoscopic group

patients in the laparoscopic group underwent laparoscopic resection of recurrent HCC

laparoscopic resection

Intervention Type 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.

control group

patients in the control group underwent conventional open surgery

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhongguo Zhou

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Li Xu

Role: STUDY_DIRECTOR

Sun Yat-sen University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B20140001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.