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

Tracking Information
First Received Date ^ICMJE	February 6, 2011
Last Updated Date	February 8, 2011
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 8, 2011)	postoperative complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] postoperative complications especially infectious complications
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01292330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 8, 2011)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
Official Title ^ICMJE	A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
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: The collection of patients with selected standard Preoperative evaluation included nutritional status,liver function and tumor characteristics The experimental group received Preoperative Nutritional Support for 4 days,the control group got nothing Both groups received conventional therapy after operation The comparation of the clinical outcomes in both groups
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Liver Cancer
Intervention ^ICMJE	Procedure: nutritional support before operation nutritional support before operation for more than 4 days
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	November 2011
Estimated Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: A diagnosis of hepatocellular carcinoma (HCC) was made before operation Nutritional Risk Screening 2002(NRS-2002) was Greater or equal 3 points with in 24 hours after admission
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01292330
Other Study ID Numbers ^ICMJE	PUMCH-Liver surgery -Nutrition
Has Data Monitoring Committee	No
Responsible Party	Dr. Yilei Mao, Peking Union Medical College Hospital
Study Sponsor ^ICMJE	Peking Union Medical College Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Peking Union Medical College Hospital
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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