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OpenTrials
Completed

NCT Number: NCT02031952

Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma

The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph node for those patients. Recently, more and more studies had found the incidence of lymph node metastasis was higher in autopsy specimen than those in operable patients.

This project is a prospective randomized controlled trial, planning to compare hepatectomy with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC patients, to reach a further understanding of the role of lymphadenectomy.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 to 65 years;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
  • good liver function with Pugh-Child Class A or B;
  • indocyanine green retention at 15 minutes (ICG-R15) <15%;
  • without severe cirrhosis;
  • the diameter of tumor is equal to or more than 3 cm;
  • the liver resection could be assessed R0 (the define of R0 resection will be explained in the section of Surgical procedures);
  • absence of extrahepatic metastasis.

Exclusion criteria

  • the diameter of tumor is less than 3 cm;
  • palliative resection of tumor;
  • with the history of hepatic encephalopathy, ascites, and variceal bleeding;
  • with severe hepatic cirrhosis;
  • tumor rupture;
  • with the history of upper abdominal surgery, it is tough to remove the regional lymph nodes; or it is unable to be resected when multiple lymph nodes mixed and fixed.

Treatment and study plan

hepatectomy combined with lymphadenectomy

Procedure

hepatectomy alone

Procedure

Primary outcomes

  1. Recurrence-free survival

    Time frame: 5 year

    The recurrence-free survival time was defined as the time from the date of resection or ablation to the time of recurrence, metastasis or last follow-up.

Secondary outcomes

  1. Post-operation complication

    Time frame: 90-d after surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma ----A Prospective Randomized Controlled Clinical Trail

Important dates

Study start
2005
Primary completion
2010
Study completion
2013
First posted
Jan 9, 2014
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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