The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

Not Applicable

Completed

• Conditions: Esophagus Cancer
• Interventions: Other: Parenteral supplement with enteral nutrition for patients after esophagectomy; Other: Enteral Nutrition alone for patients after esophagectomy

• Registration Number: NCT01669356
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-11
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Primary Completion: 2014-01
• Status Verified: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-30
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PN supplement	Parenteral supplement with enteral nutrition for patients after esophagectomy	Parenteral supplement with enteral nutrition for patients after esophagectomy
EN alone	Enteral Nutrition alone for patients after esophagectomy	Enteral nutrition alone for patients after esophagectomy

Primary Outcome Measures

Name	Time	Method
postoperative laboratory parameters changes for nutrition assessment compared to preoperation	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	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

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China