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

The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy: A Randomized Control Trial and Physiological Study

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.

Study Overview

• Status: Terminated
• Conditions: Oesophageal Cancer
• Intervention / Treatment: Procedure: gastric tube

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Peking University School of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
change of serum markers and tissue inflammatory status before and after operation	before operation (baseline), 1 month, 6 month and 12 month after operation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 29, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PKU-OES-001