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Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Reflux Symptoms: Open Esophagectomy versus Minimally Invasive

Outcome Description:

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.

Outcome Time Frame:

Survey response collected at single point in time.

Safety Issue:

No

Principal Investigator

Reza J. Mehran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0465

NCT ID:

NCT00798746

Start Date:

November 2008

Completion Date:

May 2010

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • pyloric drainage
  • pyloric drainage procedure
  • reflux
  • reflux symptoms
  • esophagectomy
  • Quality of Life
  • Health-related quality of life
  • HRQL
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030