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Quality of Life After Esophagectomy for Cancer
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00798746
  Purpose

The purpose of the current study is to assess the role of pyloric drainage procedure on altering the reflux effect on the quality of life in patients who underwent esophagectomy. We hypothesize that the patients who underwent minimally invasive esophagectomies without pyloric drainage experience less reflux symptoms and therefore have a better quality of life.


Condition Intervention
Esophageal Cancer
Behavioral: Telephone Questionnaire

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer.

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To determine if patients who underwent minimally invasive esophagectomies without pyloric drainage experience less reflux symptoms and therefore have a better quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 90
Study Start Date: November 2008
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Esophagectomy with pyloric drainage procedure.
Behavioral: Telephone Questionnaire
Ten questions regarding symptoms of reflux
2
Esophagectomy without pyloric drainage procedure.
Behavioral: Telephone Questionnaire
Ten questions regarding symptoms of reflux

Detailed Description:

Surgery is considered curative for patients with esophageal cancer. The minimally invasive approach was developed such that laparoscopy and thoracoscopy replace large abdominal and thoracic incisions. For both open and minimally invasive procedures, patients have many adjustments to overcome in order to regain quality of life that is within the norm. In a recent study on the health-related quality of life (HRQL) after curative surgical resection, symptoms of reflux was the only variable that worsened with statistical significance.

The study plan is to retrospectively compare two groups of patients: those who underwent esophagectomy with pyloric drainage procedure and those who did not. The study will be done using all MD Anderson patients who underwent minimally invasive esophagectomies, in which pyloroplasty and pyloromyotomy are not standard procedures. Clinically relevant data and demographic information will be collected retrospectively for the two groups including age, gender, Body Mass Index, level of anastomosis, and time elapsed since surgery. All patients will be interviewed via telephone. At least two attempts will be made to contact each patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults who received minimally invasive or transthoracic or transhiatal or three-field esophagectomy for primary esophageal cancer at MDACC during or after 2004.

Criteria

Inclusion Criteria:

  1. patients who are 18 years-old or older
  2. Patients who received esophagectomy indicated for primary esophageal cancer, either adenocarcinoma or squamous cell carcinoma
  3. Patients who received minimally invasive or transthoracic or transhiatal or three-field esophagectomy at MDACC during or after 2004
  4. Patients who are English-speaking and of any ethnicity
  5. Patients with prior cancers, any clinical stage of esophageal carcinoma, any performance status (as rated by American Society of Anesthesiologist Risk Scale), received or did not receive preoperative treatment, had level of anastomosis in either neck or chest

Exclusion Criteria:

1) Patients who received esophagectomies indicated for emergency, salvage or redo

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798746

Contacts
Contact: Reza J. Mehran, MD 713-794-1477

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Reza J. Mehran, MD     713-794-1477        
Principal Investigator: Reza J. Mehran, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Reza J. Mehran, MD UT MD Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: UT MD Anderson Cancer Center ( Reza J. Mehran, MD/Professor )
Study ID Numbers: 2008-0465
Study First Received: November 25, 2008
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00798746  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Esophageal cancer
pyloric drainage
pyloric drainage procedure
reflux
reflux symptoms
esophagectomy
Quality of Life
Health-related quality of life
HRQL

Study placed in the following topic categories:
Digestive System Neoplasms
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Neoplasms
Quality of Life
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009