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The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

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ClinicalTrials.gov Identifier: NCT01669356
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Esophagus Cancer Other: Parenteral supplement with enteral nutrition for patients after esophagectomy Other: Enteral Nutrition alone for patients after esophagectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : July 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

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Arm Intervention/treatment
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



Primary Outcome Measures :
  1. postoperative laboratory parameters changes for nutrition assessment compared to preoperation [ Time Frame: from one day before surgery to the 7th postoperative day ]
    plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts

  2. postoperative body composition change compared to preoperation measurement [ Time Frame: 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


Other Outcome Measures:
  1. complicatons incidence after surgery [ Time Frame: 28 days after surgery ]
    complications involve anastomotic leakage, incision infection, pneumonia, catherter-related blood stream infection, respiratory failure



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669356


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

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01669356     History of Changes
Other Study ID Numbers: PNsupplESO
Energy Supply Trial ( Other Identifier: Shanghai Zhongshan Hospital )
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

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