Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC

NCT02014025 | Completed DMC

• 2 other identifiers: SWHZSG004Zhengshuguo
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare short-term and long-term efficacy of laparoscope hepatectomy and open hepatectomy, evaluate the safety and efficacy of laparoscope hepatectomy the PHC with a tumor size of 5～10㎝,and provide class B evidence based medicine for laparoscope hepatectomy for PHC with a tumor size of 5～10㎝.

Conditions

Primary Liver Carcinoma

Keywords

Laparoscope hepatectomy; Open hepatectomy; large PHC; safety and sensibility

Outcome Measures

Primary Outcomes (1)

• survival rate

  follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates，disease-free survival rates , recurrence and metastasis rate.

  3-year

Secondary Outcomes (1)

• intraoperative parameters

  during the operation

Other Outcomes (1)

• postoperative complications

  Duration hospitalization(an expected average of 7 days)

Study Arms (2)

laparoscope hepatectomy

EXPERIMENTAL

We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery E district is Group B ,they will accept laparoscopic hepatectomy: tumors are totally resected through laparoscopic.

Procedure: Laparoscope hepatectomy

open hepatectomy

EXPERIMENTAL

We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery A and D district is Group A ,they will accept Open Hepatectomy: tumors are totally resected by conventional laparotomy.

Procedure: Open hepatectomy

Interventions

Open hepatectomy PROCEDURE

We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery A and D district is Group A ,they will accept Open Hepatectomy: tumors are totally resected by conventional laparotomy.

open hepatectomy

Laparoscope hepatectomy PROCEDURE

We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery E district is Group B ,they will accept Laparoscopic Hepatectomy: tumors are totally resected through laparoscopic.

laparoscope hepatectomy

Eligibility Criteria

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

You may qualify if:

• both male and female, aged 18 to 70;
• PHC diagnosis is clear preoperative;
• No active hepatitis and decompensated cirrhosis
• tumor size of 5-10 cm,no intrahepatic or distant metastasis,no tumor thrombus in the portal vein, hepatic vein, vena cava, or bile duct; and no invasion of the diaphragm or surrounding tissues;
• no rupture or bleeding of the tumor;
• Child-Pugh class A or B liver function;
• indocyanine green retention rate at 15 min of \<15%, and a remnant liver volume/standard liver volume ratio of \>50% in patients with liver cirrhosis and \>35% in patients without liver cirrhosis;
• upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy And Embolization treatment, radiotherapy and chemotherapy have not been implemented and no previous surgery that absolutely contraindicated Laparoscope hepatectomy.
• General condition of patients and cardiopulmonary function enough to tolerate surgery
• voluntary participation in the study, and informed consent.
• meet the criteria for Laparoscope hepatectomy group;

You may not qualify if:

• (1) age \<18 years or\> 70 years , pregnant or lactating women; (2) tumor size ≥10 cm, or tumor location that would interfere with intraoperative exposure and isolation of the hepatic hilum; (3) tumor encroaching on the hepatic hilum , the portal vein, primary bile duct or tumor adjacent to the major vascular structures ; (4) unable to tolerate a pneumoperitoneum or can't tolerate surgery duo to cardiopulmonary dysfunction; (5) severe upper abdominal adhesions; (6)Pathologically confirmed positive margins

Sponsors & Collaborators

• Shuguo Zheng, MD: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Shuguo Zheng

  Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 17, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

CN (1)