Clinical trial NCT00798746: Quality of Life After Esophagectomy for Cancer
Official title: Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
pyloric drainage
pyloric drainage procedure
reflux
reflux symptoms
esophagectomy
Quality of Life
Health-related quality of life
HRQL
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Reflux Symptoms: Open Esophagectomy versus Minimally Invasive
timeFrame: Survey response collected at single point in time.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Reza J. Mehran, MD
role: PRINCIPAL_INVESTIGATOR
References: