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

H

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)

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)

Trial contacts and locations

1

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Central trial contact

Xiaoping Chen, M.D.; Binhao Zhang, M.D.

Data sourced from clinicaltrials.gov

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