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NCT01292330 Clinical Trial

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

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01292330
Other study ID # PUMCH-Liver surgery -Nutrition
Secondary ID
Status Recruiting
Phase N/A
First received February 6, 2011
Last updated February 8, 2011
Start date January 2010
Est. completion date November 2011

Study information
Verified date February 2011
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date November 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• nutritional support before operation
nutritional support before operation for more than 4 days

Locations
Country Name City State
China Yilei Mao Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative complications postoperative complications especially infectious complications 2 years Yes
Secondary hospitalization expenses and length of stay hospitalization expenses:nutrition-related expenses length of stay:from the date of the operation to the date of Discharge 2 years Yes
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