Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Peking University.
Recruitment status was:  Recruiting
Information provided by:
Peking University Identifier:
First received: May 24, 2011
Last updated: May 26, 2011
Last verified: March 2011
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

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 ]

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


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01361750

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

Responsible Party: Feng Yuan, Attending Doctor, Thoracic Ward II, School of Oncoloy & Beijing Cancer Hospital, Peking University Identifier: NCT01361750     History of Changes
Other Study ID Numbers: PKU-OES-001
Study First Received: May 24, 2011
Last Updated: May 26, 2011 processed this record on May 23, 2017