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Completed

NCT Number: NCT00825474

A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma

Presently,the diagnostic method of small hepatocellular carcinoma has been greatly elevated in China.The treatment is being from simplification to diversification,from entirety to individualization.Confronting small hepatocellular carcinoma,we not select simple operation treatment but select a treatment that have more predominance and more fitting with patients in various kinds of treatment methods;including operation ,TACE,PEI,et al.which is better ? There are many arguments.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

About this study

randomly put in group standard:

  • via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
  • age: 18-70 years.
  • early hepatocyte cancer,which is single focus of infection diameter ≤ 3 cm.
  • estimate tumor can gain treatment of curing operation or TACE plus PEI.
  • better liver function (Child-Pugh,class A or B).

Case loads: 160 residents with small hepatocellular carcinoma in China

Therapeutic regimen: under normal rules, the operation group open abdomen to perform operation through subtotal incision while the patient has been general anesthesia with trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection treatment.

Research end-point:

  • ensemble life span.To compare 1、2 and 3 year overall survival rate in hepatectomy and TACE plus PEI for small hepatocellular carcinoma
  • intraliver recurrence rate; distant metastasis rate; non-tumor life span; band tumor life span

Telephone call at any time

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
  • age:18-70years
  • early hepatocyte cancer,which is single focus of infection diameter ≤3cm.
  • estimate tumor can gain treatment of curing operation or micro-create treatment combineation
  • better liver function (Child-Pugh,class A or B)

Exclusion criteria

  • reject to attend;
  • impossible to come to our hospital for physical examination regularly.
  • cancer epitome、seed focus、lymph node or distant metastasis
  • Blood clotting function hindrance;
  • serious heart、lung、kidney disease.

Treatment and study plan

operation;TACE plus PEI

Other

Under normal rules, the operation group open abdomen to perform operation through subtotal incision while the patient has been general anesthesia with trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection treatment.

Other names: surgical resection

Primary outcomes

  1. overall survival

    Time frame: 2010

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 21, 2009
Registry last updated
Apr 1, 2016

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

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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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