The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients

Esophagus Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669356
• Other study ID #: PNsupplESO
• Secondary ID: Energy Supply Tr
• Status: Completed
• Phase: N/A
• First received: August 11, 2012
• Last updated: March 30, 2014
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagus Cancer

Intervention

Other:
• Parenteral supplement with enteral nutrition for patients after esophagectomy

• Enteral Nutrition alone for patients after esophagectomy

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complicatons incidence after surgery	complications involve anastomotic leakage, incision infection, pneumonia, catherter-related blood stream infection, respiratory failure	28 days after surgery	Yes
Primary	postoperative laboratory parameters changes for nutrition assessment compared to preoperation	plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts	from one day before surgery to the 7th postoperative day	Yes
Primary	postoperative body composition change compared to preoperation measurement	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	Yes