The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

March 30, 2014 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • ZhongShan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from one day before surgery to the 7th postoperative day
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
from one day before surgery to the 7th postoperative day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
complicatons incidence after surgery
Time Frame: 28 days after surgery
complications involve anastomotic leakage, incision infection, pneumonia, catherter-related blood stream infection, respiratory failure
28 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 11, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 21, 2012

Study Record Updates

Last Update Posted (Estimate)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 30, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNsupplESO
  • Energy Supply Trial (Other Identifier: Shanghai Zhongshan Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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