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

Not Applicable

• Conditions: Cancer Progression
• Interventions: Procedure: hepatectomy (rapid ligating); Procedure: hepatectomy (conventional method)

• Registration Number: NCT02319863
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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

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 Timeline

• Study Start: 1994-02
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-15
• Last Update Submitted: 2014-12-15
• Study First Posted: 2014-12-18
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
new method	hepatectomy (rapid ligating)	The new technique of rapid ligating the corresponding inflow and outflow vessels without hills dissection before parenchyma transection during hepatectomy.
conventional resection	hepatectomy (conventional method)	Perform hepatectomy with conventional method for HCC patients.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Prognosis	5 years	to check the 5 years overall survival (OS) and disease free survival (DFS)

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China