NCT01292330

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 9, 2011

Status Verified

February 1, 2011

Enrollment Period

1.7 years

First QC Date

February 6, 2011

Last Update Submit

February 8, 2011

Conditions

Liver Cancer

Keywords

liver Tumor

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    postoperative complications especially infectious complications

    2 years

Secondary Outcomes (1)

  • hospitalization expenses and length of stay

    2 years

Interventions

nutritional support before operationPROCEDURE

nutritional support before operation for more than 4 days

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yilei Mao

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24570910DERIVED

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2011

First Posted

February 9, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

February 9, 2011

Record last verified: 2011-02

Locations

CN(1)