The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01669356
First received: August 11, 2012
Last updated: March 30, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Esophagus Cancer
Other: Parenteral supplement with enteral nutrition for patients after esophagectomy
Other: Enteral Nutrition alone for patients after esophagectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • postoperative laboratory parameters changes for nutrition assessment compared to preoperation [ Time Frame: from one day before surgery to the 7th postoperative day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition


Other Outcome Measures:
  • complicatons incidence after surgery [ Time Frame: 28 days after surgery ] [ Designated as safety issue: Yes ]
    complications involve anastomotic leakage, incision infection, pneumonia, catherter-related blood stream infection, respiratory failure


Enrollment: 95
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PN supplement
Parenteral supplement with enteral nutrition for patients after esophagectomy
Other: Parenteral supplement with enteral nutrition for patients after esophagectomy
Active Comparator: EN alone
Enteral nutrition alone for patients after esophagectomy
Other: Enteral Nutrition alone for patients after esophagectomy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01669356

Locations
China
Zhongshan Hospital Fudan University
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
  More Information

No publications provided

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01669356     History of Changes
Other Study ID Numbers: PNsupplESO, Energy Supply Trial
Study First Received: August 11, 2012
Last Updated: March 30, 2014
Health Authority: China: Ministry of Health

Keywords provided by Shanghai Zhongshan Hospital:
malnutrition
parenteral supplement
rest metabolic rate
postoperative complications

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 23, 2014