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

Primary Purpose

Liver Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nutritional support before operation
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Cancer focused on measuring liver Tumor

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yilei MaoRecruiting

Outcomes

Primary Outcome Measures

postoperative complications
postoperative complications especially infectious complications

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2011
Last Updated
February 8, 2011
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01292330
Brief Title
A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
Official Title
A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. 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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
liver Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
nutritional support before operation
Intervention Description
nutritional support before operation for more than 4 days
Primary Outcome Measure Information:
Title
postoperative complications
Description
postoperative complications especially infectious complications
Time Frame
2 years
Secondary Outcome Measure Information:
Title
hospitalization expenses and length of stay
Description
hospitalization expenses:nutrition-related expenses length of stay:from the date of the operation to the date of Discharge
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yilei Mao
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yilei Mao, associate professor
Phone
86-10-65296042
Email
liying1272@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24570910
Citation
Lu X, Li Y, Yang H, Sang X, Zhao H, Xu H, Du S, Xu Y, Chi T, Zhong S, Yu K, Mao Y. Improvement of nutritional support strategies after surgery for benign liver tumor through nutritional risk screening: a prospective, randomized, controlled, single-blind clinical study. Hepatobiliary Surg Nutr. 2013 Feb;2(1):14-21. doi: 10.3978/j.issn.2304-3881.2012.11.04.
Results Reference
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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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