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Completed

NCT Number: NCT01669356

The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

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.

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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parenteral supplement with enteral nutrition for patients after esophagectomy

Other

Enteral Nutrition alone for patients after esophagectomy

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2012
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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