Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
- Conditions
- Esophagectomy
- Interventions
- Procedure: EsophagectomyProcedure: Pyloroplasty
- Registration Number
- NCT03740542
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 143
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Esophagectomy without Pyloroplasty Esophagectomy Esophagectomy without Pyloroplasty Esophagectomy with Pyloroplasty Esophagectomy Esophagectomy with Pyloroplasty Esophagectomy with Pyloroplasty Pyloroplasty Esophagectomy with Pyloroplasty
- Primary Outcome Measures
Name Time Method esophageal anastomosis leak requiring surgery 30 days postoperatively Defined as a leak at the esophageal anastomosis site as evidenced by Barium Swallow Study.
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
- Secondary Outcome Measures
Name Time Method Mortality 30 days Death within 30 days of surgery
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
Aspiration as reported on radiographic imaging Performed when clinically indicated up to 24 months postoperatively Radiographic imaging reports
Esophageal anastomotic leak not requiring surgery Performed when clinically indicated up to 24 months postoperatively Barium swallow reports
Time to start oral diet Up to 24 months Number of days from surgery to starting oral diet
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
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.
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
Unexpected return to the Operating Room Up to 24 months postoperatively Procedure performed in the Operating Room
Respiratory complications other than pneumonia Performed when clinically indicated up to 24 months postoperatively Radiographic imaging reports
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
Esophageal dilations reported as the number of esophageal dilations performed Up to 24 months Number of esophageal dilations performed
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
Trial Locations
- Locations (2)
University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital
šŗšøPittsburgh, Pennsylvania, United States
Department of Cardiothoracic Surgery
šŗšøPittsburgh, Pennsylvania, United States