Quality of Life After Esophagectomy for Cancer

July 27, 2012 updated by: M.D. Anderson Cancer Center

Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer

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. Researchers hypothesize that the patients who underwent minimally invasive esophagectomies without pyloric drainage experience less reflux symptoms and therefore have a better quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pyloric Drainage Procedure
Esophagectomy with pyloric drainage procedure
Behavioral: Telephone Questionnaire
Ten questions regarding symptoms of reflux
Other Names:
  • Reflux Survey
  • Gastrointestinal Symptoms Rating Scale
  • GSRS
  • Quality of life questionnaires
  • Health-related quality of life
  • HRQL
No Pyloric Drainage Procedure
Esophagectomy without pyloric drainage procedure
Behavioral: Telephone Questionnaire
Ten questions regarding symptoms of reflux
Other Names:
  • Reflux Survey
  • Gastrointestinal Symptoms Rating Scale
  • GSRS
  • Quality of life questionnaires
  • Health-related quality of life
  • HRQL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reflux Symptoms: Open Esophagectomy versus Minimally Invasive
Time Frame: Survey response collected at single point in time.
Comparison of reflux symptoms in patients who underwent open esophagectomies with pyloric drainage and those who received minimally invasive esophagectomies without pyloric drainage. The survey consisted of ten questions regarding symptoms associated with reflux using Gastrointestinal Symptoms Rating Scale (GSRS). Responses to degree of reflux distress rated on a six-point scale for questions with "0" indicating no heartburn symptoms and "5" indicating most symptoms experienced.
Survey response collected at single point in time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Reza J. Mehran, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0465

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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