The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

NCT ID: NCT01669356

Last Updated: 2014-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-03-31

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.

Detailed Description

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Conditions

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Esophagus Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PN supplement

Parenteral supplement with enteral nutrition for patients after esophagectomy

Group Type EXPERIMENTAL

Parenteral supplement with enteral nutrition for patients after esophagectomy

Intervention Type OTHER

EN alone

Enteral nutrition alone for patients after esophagectomy

Group Type ACTIVE_COMPARATOR

Enteral Nutrition alone for patients after esophagectomy

Intervention Type OTHER

Interventions

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Parenteral supplement with enteral nutrition for patients after esophagectomy

Intervention Type OTHER

Enteral Nutrition alone for patients after esophagectomy

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital Fudan University

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 27208039 (View on PubMed)

Other Identifiers

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Energy Supply Trial

Identifier Type: OTHER

Identifier Source: secondary_id

PNsupplESO

Identifier Type: -

Identifier Source: org_study_id

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