Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

This study examines the role of this simple technique on postoperative metastasis and long term survival.

Study Overview

• Status: Unknown
• Conditions: Cancer Progression
• Intervention / Treatment: Procedure: hepatectomy (conventional method); Procedure: hepatectomy (rapid ligating)

Detailed Description

The only hope of long-term survival for patients with primary hepatocellular carcinoma (HCC) is surgical resection or liver transplantation, the former of which is more feasible at present. However, postoperative recurrence or metastasis is an ominous feature for this disease. Innovation of the surgical procedure for improving prognosis is under emergency request. This study examines the role of this simple technique on postoperative metastasis and long term survival.

During the past 20 years, more 600 patients with primary HCC were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (RCT) was applied. We further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Xiaoping Chen, M.D.; Phone Number: +86 27 83662851; Email: chenxp@medmail.com.cn
      • Contact: Binhao Zhang, M.D.; Phone Number: +86 15802726021; Email: bhzhang8@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HCC patients who will perform left- or right- hemihepatectomy.

Exclusion Criteria:

1. contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)>30%,serum hepatitis B virus (HBV)-DNA>106 copies/ml and serum alanine aminotransferase (ALT)>2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause;
2. pregnancy;
3. age of<18y or>65y

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional resection; Perform hepatectomy with conventional method for HCC patients.	Procedure: hepatectomy (conventional method); A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy; Other Names: liver resection
Experimental: new method; The new technique of rapid ligating the corresponding inflow and outflow vessels without hills dissection before parenchyma transection during hepatectomy.	Procedure: hepatectomy (rapid ligating)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence	to examine if there is intrahepatic recurrence	12 months
metastasis	to examine if there is intrahepatic metastasis and metastasis in distant organs	12 months
mortality	intraoperative death， and death in one month after surgery	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognosis	to check the 5 years overall survival (OS) and disease free survival (DFS)	5 years

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Xiaoping Chen, M.D., Tongji Hospital

Publications and helpful links

General Publications

• Chen XP, Qiu FZ. A simple technique ligating the corresponding inflow and outflow vessels during anatomical left hepatectomy. Langenbecks Arch Surg. 2008 Mar;393(2):227-30; discussion 231-4. doi: 10.1007/s00423-007-0224-z. Epub 2007 Nov 3.

Study record dates

Study Major Dates

• Study Start: February 1, 1994
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: prognosis; hepatocellular carcinoma
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: Chenxp5; 2012ZX10002016-004 (Other Grant/Funding Number: The State Key Project on Inflection Disease of China)