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

• Sponsor: Peking University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01361750
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 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 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change of nutritional status and quality of life before and after operation [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 [before operation (baseline), 1 month, 6 month and 12 month after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Peking University School of Oncology	Beijing	Beijing	China	100142

Sponsors and Collaborators

• Peking University

Investigators

• Principal Investigator: Yue Yang, M.D., Peking University Health Science Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yang Yue, Thoracic Surgery II, Peking University
• ClinicalTrials.gov Identifier: NCT01361750
• Other Study ID Numbers: PKU-OES-001
• First Posted: May 27, 2011
• Last Update Posted: Mar 31, 2020
• Last Verified: Mar 1, 2020

Study Results

No Results Posted as of Mar 31, 2020