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

NCT00825474 | Completed DMC

• 1 other identifier: EHBH-RCT-2008-003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

small hepatocellular carcinoma; partial hepatectomy; TACE plus PEI

Outcome Measures

Primary Outcomes (1)

• overall survival

  2010

Study Arms (1)

survival rate

EXPERIMENTAL

therapeutic effect of partial hepatectomy or TACE plus PEI for small hepatocellular carcinoma

Other: operation;TACE plus PEI

Interventions

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.

Also known as: surgical resection

survival rate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• shen feng, MD

  Eastern Hepatobiliary Surgery Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 21, 2009
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2010
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)