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

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ClinicalTrials.gov Identifier: NCT01361750
Recruitment Status : Unknown
Verified March 2011 by Peking University.
Recruitment status was:  Recruiting
First Posted : May 27, 2011
Last Update Posted : May 27, 2011
Sponsor:
Information provided by:
Peking University

Brief Summary:
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 or disease Intervention/treatment Phase
Oesophageal Cancer Procedure: gastric tube Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : May 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: March 2011