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
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 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

ClinicalTrials.gov processed this record on September 18, 2014