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
  Purpose

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.


Condition Intervention Phase
Oesophageal Cancer
Procedure: gastric tube
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy: A Randomized Control Trial and Physiological Study

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 144
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gastirc tube group
conduit will be perfomed by narrowed gastric tube
Procedure: gastric tube
the stomach will be cut into a narrowed tube-shape conduit
No Intervention: control group
conduit will be traditional subtotal stomach without any surgical modification

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361750

Locations
China, Beijing
Peking University School of Oncology Recruiting
Beijing, Beijing, China, 100142
Contact: Yuan Feng, M.D.    86-13522791515    fengyuan0115@hotmail.com   
Sub-Investigator: Nan Wu, M.D.         
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Yue Yang, M.D. Peking University Health Science Center
  More Information

No publications provided

Responsible Party: Feng Yuan, Attending Doctor, Thoracic Ward II, School of Oncoloy & Beijing Cancer Hospital, Peking University
ClinicalTrials.gov Identifier: NCT01361750     History of Changes
Other Study ID Numbers: PKU-OES-001
Study First Received: May 24, 2011
Last Updated: May 26, 2011
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014