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

History of Changes

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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

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 Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013

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