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

Huazhong University of Science and Technology

Status: Unknown

Conditions: Cancer Progression

Treatments: Procedure: hepatectomy (conventional method); Procedure: hepatectomy (rapid ligating)

Study type: Interventional

Funder types: Other

Identifiers

NCT02319863

Chenxp5

2012ZX10002016-004 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

conventional resection

Active Comparator group

Description:

Perform hepatectomy with conventional method for HCC patients.

Treatment:

Procedure: hepatectomy (conventional method)

new method

Experimental group

Description:

The new technique of rapid ligating the corresponding inflow and outflow vessels without hills dissection before parenchyma transection during hepatectomy.

Treatment:

Procedure: hepatectomy (rapid ligating)