Esophagectomy
Conditions
Brief summary
This research study is a phase III randomized trial to study the value of the addition of a pyloroplasty procedure versus no pyloroplasty procedure during the performance of esophagectomy. Pyloroplasty is a type of pyloric drainage procedure.
Detailed description
Patients selected for enrollment in this study will be adults (18-85 years of age) that have been scheduled for exploration, and possible esophagectomy. Prior to surgery, patients will be randomized to one of two groups. Group A will have a pyloroplasty performed as part of the esophagectomy procedure. Group B will not have a pyloroplasty performed. Postoperative patient outcomes will be assessed for 24 months.
Interventions
PROCEDUREEsophagectomy
Surgical removal of part of esophagus
PROCEDUREPyloroplasty
pyloric drainage procedure
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must be willing to undergo esophagectomy for benign or malignant condition * Women and men 18-85 years of age * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Stomach is used as conduit
Exclusion criteria
* Previous operations of the pylorus * Previous gastric resection * Previous gastric bypass * Patients who are unable to tolerate surgery * Participants may be enrolled and randomized on the study but may be excluded at the time of the surgery because of findings by the surgeon that preclude performing esophagectomy, or using stomach as a conduit or findings which preclude following the randomized arm. * Age \<18 years of age or \> 85 years of age * BMI \> 50 * Liver cirrhosis or liver failure at physician's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pneumonia | 30 days postoperatively | Defined as meeting 3 of 5 characteristics: fever, leukocytosis, chest x-ray (CXR) with infiltrate, positive culture from sputum, or treatment with antibiotics |
| esophageal anastomosis leak requiring surgery | 30 days postoperatively | Defined as a leak at the esophageal anastomosis site as evidenced by Barium Swallow Study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | Death within 30 days of surgery |
| Time to start oral diet | Up to 24 months | Number of days from surgery to starting oral diet |
| Quality of life assessment by completion of SF36 Quality of Life questionnaire | Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery | SF36 Quality of Life questionnaire |
| Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life (HRQL) measured by completion of GERD HRQL questionnaire | Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery. | Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life (HRQL) questionnaire prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery. |
| Dysphagia as reported by patient using the Dysphagia scale | Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery. | Dysphagia scale measures swallowing difficulty on a scale of 1-5. (1=no difficulty swallowing; 2=difficulty swallowing hard solids; 3=difficulty swallowing soft solids; 4=difficulty swallowing liquids; 5=unable to swallow anything. A lower score represents a better outcome. |
| Nasogastric tube drainage measured in milliliters | From date of surgery until date nasogastric tube is removed or date of discharge from hospital, whichever came first, assessed up to 24 months. | Measured in milliliters |
| Replacement of nasogastric tube reported as number of days from tube removal to reinsertion | Up to 24 months | Number of days from nasogastric tube removal to reinsertion |
| Esophageal dilations reported as the number of esophageal dilations performed | Up to 24 months | Number of esophageal dilations performed |
| Length of hospital stay | From date of surgery until the date of discharge from hospital, assessed up to 24 months. | Number of days in hospital |
| Aspiration as reported on radiographic imaging | Performed when clinically indicated up to 24 months postoperatively | Radiographic imaging reports |
| Gastric outlet obstruction as reported on barium swallow reports | Performed when clinically indicated up to 24 months postoperatively | Barium swallow reports |
| Re-admission to hospital | Up to 24 months postoperatively | Number of days from hospital discharge to re-admission |
| Unexpected return to the Operating Room | Up to 24 months postoperatively | Procedure performed in the Operating Room |
| Esophageal anastomotic leak not requiring surgery | Performed when clinically indicated up to 24 months postoperatively | Barium swallow reports |
| Respiratory complications other than pneumonia | Performed when clinically indicated up to 24 months postoperatively | Radiographic imaging reports |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames Luketich, MD
University of Pittsburgh
Outcome results
None listed