The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophagus Cancer

Intervention / Treatment
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* Other: Parenteral supplement with enteral nutrition for patients after esophagectomy
* Other: Enteral Nutrition alone for patients after esophagectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PN supplement<br>Parenteral supplement with enteral nutrition for patients after esophagectomy | Other: Parenteral supplement with enteral nutrition for patients after esophagectomy<br> <br> |
| Active Comparator: EN alone<br>Enteral nutrition alone for patients after esophagectomy | Other: Enteral Nutrition alone for patients after esophagectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, parenteral supplement, rest metabolic rate, postoperative complications