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A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support

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ClinicalTrials.gov Identifier: NCT01292330
Recruitment Status : Unknown
Verified February 2011 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : February 9, 2011
Last Update Posted : February 9, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After Preoperative Nutritional Support.

Study design:

1.Prospective,randomized, controlled clinical study;2.Patients: The subjects were from Peking Union Medical College Hospital (PUMCH).

Study arrangement:

  1. The collection of patients with selected standard
  2. Preoperative evaluation included nutritional status,liver function and tumor characteristics
  3. The experimental group received Preoperative Nutritional Support for 4 days,the control group got nothing
  4. Both groups received conventional therapy after operation
  5. The comparation of the clinical outcomes in both groups

Condition or disease Intervention/treatment
Liver Cancer Procedure: nutritional support before operation

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
Study Start Date : January 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: nutritional support before operation
    nutritional support before operation for more than 4 days

Outcome Measures

Primary Outcome Measures :
  1. postoperative complications [ Time Frame: 2 years ]
    postoperative complications especially infectious complications


Secondary Outcome Measures :
  1. hospitalization expenses and length of stay [ Time Frame: 2 years ]
    hospitalization expenses:nutrition-related expenses length of stay:from the date of the operation to the date of Discharge


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of hepatocellular carcinoma (HCC) was made before operation
  2. Nutritional Risk Screening 2002(NRS-2002) was Greater or equal 3 points with in 24 hours after admission
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292330


Locations
China, Beijing
Yilei Mao Recruiting
Beijing, Beijing, China, 100730
Contact: Yilei Mao, associate professor    86-10-65296042    liying1272@126.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Yilei Mao, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01292330     History of Changes
Other Study ID Numbers: PUMCH-Liver surgery -Nutrition
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 9, 2011
Last Verified: February 2011

Keywords provided by Peking Union Medical College Hospital:
liver Tumor

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases