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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Peking Union Medical College Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01292330
First received: February 6, 2011
Last updated: February 8, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention
Liver Cancer
 Procedure: nutritional support before operation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    postoperative complications especially infectious complications


Secondary Outcome Measures:
  • hospitalization expenses and length of stay [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    hospitalization expenses:nutrition-related expenses length of stay:from the date of the operation to the date of Discharge


Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: nutritional support before operation
    nutritional support before operation for more than 4 days
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 6, 2011
Last Updated: February 8, 2011
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013