Back to resultsThe Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
Primary Purpose
Esophagus Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Parenteral supplement with enteral nutrition for patients after esophagectomy
Enteral Nutrition alone for patients after esophagectomy
Sponsored by
About this trial
This is an interventional treatment trial for Esophagus Cancer focused on measuring malnutrition, parenteral supplement, rest metabolic rate, postoperative complications
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
Sites / Locations
- Zhongshan Hospital Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PN supplement
EN alone
Arm Description
Parenteral supplement with enteral nutrition for patients after esophagectomy
Enteral nutrition alone for patients after esophagectomy
Outcomes
Primary Outcome Measures
postoperative laboratory parameters changes for nutrition assessment compared to preoperation
plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts
postoperative body composition change compared to preoperation measurement
postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition
Secondary Outcome Measures
Full Information
NCT ID
NCT01669356
First Posted
August 11, 2012
Last Updated
March 30, 2014
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01669356
Brief Title
The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
Official Title
The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer
Keywords
malnutrition, parenteral supplement, rest metabolic rate, postoperative complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PN supplement
Arm Type
Experimental
Arm Description
Parenteral supplement with enteral nutrition for patients after esophagectomy
Arm Title
EN alone
Arm Type
Active Comparator
Arm Description
Enteral nutrition alone for patients after esophagectomy
Intervention Type
Other
Intervention Name(s)
Parenteral supplement with enteral nutrition for patients after esophagectomy
Intervention Type
Other
Intervention Name(s)
Enteral Nutrition alone for patients after esophagectomy
Primary Outcome Measure Information:
Title
postoperative laboratory parameters changes for nutrition assessment compared to preoperation
Description
plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts
Time Frame
from one day before surgery to the 7th postoperative day
Title
postoperative body composition change compared to preoperation measurement
Description
postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition
Time Frame
from one day before surgery to the 7th postoperative day
Other Pre-specified Outcome Measures:
Title
complicatons incidence after surgery
Description
complications involve anastomotic leakage, incision infection, pneumonia, catherter-related blood stream infection, respiratory failure
Time Frame
28 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
27208039
Citation
Wu W, Zhong M, Zhu DM, Song JQ, Huang JF, Wang Q, Tan LJ. Effect of Early Full-Calorie Nutrition Support Following Esophagectomy: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2017 Sep;41(7):1146-1154. doi: 10.1177/0148607116651509. Epub 2016 May 20.
Results Reference
derived
Learn more about this trial
The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
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