The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01361750
First received: May 24, 2011
Last updated: May 26, 2011
Last verified: March 2011

May 24, 2011
May 26, 2011
May 2011
May 2012   (final data collection date for primary outcome measure)
change of nutritional status and quality of life before and after operation [ Time Frame: before operation (baseline), 1 month, 6 month and 12 month after operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01361750 on ClinicalTrials.gov Archive Site
change of serum markers and tissue inflammatory status before and after operation [ Time Frame: before operation (baseline), 1 month, 6 month and 12 month after operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy
The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy: A Randomized Control Trial and Physiological Study

This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Oesophageal Cancer
Procedure: gastric tube
the stomach will be cut into a narrowed tube-shape conduit
  • Experimental: gastirc tube group
    conduit will be perfomed by narrowed gastric tube
    Intervention: Procedure: gastric tube
  • No Intervention: control group
    conduit will be traditional subtotal stomach without any surgical modification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
May 2013
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • esophageal cancer (squamous and adenocarcinoma subtypes)
  • eligble for Ivor-Lowis esophagectomy
  • expected survival time longer than 12 months

Exclusion Criteria:

  • palliative resection(non-R0)
  • anastomosis leak
  • jejunum or colon transversum interponate
Both
30 Years to 75 Years
No
China
 
NCT01361750
PKU-OES-001
Yes
Feng Yuan, Attending Doctor, Thoracic Ward II, School of Oncoloy & Beijing Cancer Hospital, Peking University
Peking University
Not Provided
Principal Investigator: Yue Yang, M.D. Peking University Health Science Center
Peking University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP