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Clinical Trials/NCT01669356
NCT01669356
Completed
Not Applicable

The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial

Shanghai Zhongshan Hospital1 site in 1 country95 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophagus Cancer
Sponsor
Shanghai Zhongshan Hospital
Enrollment
95
Locations
1
Primary Endpoint
postoperative laboratory parameters changes for nutrition assessment compared to preoperation
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Malnutrition is common in esophagus cancer patients, especially after surgery therapy. Whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. In this study, the investigators are to examine the effect of enteral nutrition supplemented with parenteral nutrtion on nutrition status after esophagectomy.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
March 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of esophagus cancer
  • Undergo esophagectomy
  • Nasoenteral tube is placed or surgical jejunostomy is performed

Exclusion Criteria

  • Contraindication for enteral nutrition or parenteral nutrition
  • Malnutrition before surgery ( BMI \> 30 or \< 18.5)
  • Hepatic dysfunction preoperatively
  • Renal dysfunction preoperatively
  • Infection before surgery
  • Usage of corticosteroid before surgery

Outcomes

Primary Outcomes

postoperative laboratory parameters changes for nutrition assessment compared to preoperation

Time Frame: from one day before surgery to the 7th postoperative day

plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts

postoperative body composition change compared to preoperation measurement

Time Frame: from one day before surgery to the 7th postoperative day

postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition

Study Sites (1)

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