The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
2 other identifiers
interventional
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 11, 2012
CompletedFirst Posted
Study publicly available on registry
August 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 1, 2014
March 1, 2014
1.5 years
August 11, 2012
March 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
postoperative laboratory parameters changes for nutrition assessment compared to preoperation
plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts
from one day before surgery to the 7th postoperative day
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
from one day before surgery to the 7th postoperative day
Other Outcomes (1)
complicatons incidence after surgery
28 days after surgery
Study Arms (2)
PN supplement
EXPERIMENTALParenteral supplement with enteral nutrition for patients after esophagectomy
EN alone
ACTIVE COMPARATOREnteral nutrition alone for patients after esophagectomy
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of esophagus cancer
- Undergo esophagectomy
- Nasoenteral tube is placed or surgical jejunostomy is performed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Related Publications (1)
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.
PMID: 27208039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2012
First Posted
August 21, 2012
Study Start
July 1, 2012
Primary Completion
January 1, 2014
Study Completion
March 1, 2014
Last Updated
April 1, 2014
Record last verified: 2014-03