Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

Conditions
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Esophagectomy

Intervention / Treatment
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* Procedure: Esophagectomy
* Procedure: Pyloroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Esophagectomy with Pyloroplasty<br>Esophagectomy with Pyloroplasty | Procedure: Esophagectomy<br>* Surgical removal of part of esophagus<br>Procedure: Pyloroplasty<br>* pyloric drainage procedure<br>|
| Experimental: Esophagectomy without Pyloroplasty<br>Esophagectomy without Pyloroplasty | Procedure: Esophagectomy<br>* Surgical removal of part of esophagus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pneumonia | Defined as meeting 3 of 5 characteristics: fever, leukocytosis, chest x-ray (CXR) with infiltrate, positive culture from sputum, or treatment with antibiotics | 30 days postoperatively | 
| esophageal anastomosis leak requiring surgery | Defined as a leak at the esophageal anastomosis site as evidenced by Barium Swallow Study. | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death within 30 days of surgery | 30 days | 
| Time to start oral diet | Number of days from surgery to starting oral diet | Up to 24 months | 
| Quality of life assessment by completion of SF36 Quality of Life questionnaire | SF36 Quality of Life 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) measured by completion of GERD HRQL questionnaire | 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. | 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 | 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. | Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery. | 
| Nasogastric tube drainage measured in milliliters | 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. | 
| Replacement of nasogastric tube reported as number of days from tube removal to reinsertion | Number of days from nasogastric tube removal to reinsertion | Up to 24 months | 
| Esophageal dilations reported as the number of esophageal dilations performed | Number of esophageal dilations performed | Up to 24 months | 
| Length of hospital stay | Number of days in hospital | From date of surgery until the date of discharge from hospital, assessed up to 24 months. | 
| Aspiration as reported on radiographic imaging | Radiographic imaging reports | Performed when clinically indicated up to 24 months postoperatively | 
| Gastric outlet obstruction as reported on barium swallow reports | Barium swallow reports | Performed when clinically indicated up to 24 months postoperatively | 
| Re-admission to hospital | Number of days from hospital discharge to re-admission | Up to 24 months postoperatively | 
| Unexpected return to the Operating Room | Procedure performed in the Operating Room | Up to 24 months postoperatively | 
| Esophageal anastomotic leak not requiring surgery | Barium swallow reports | Performed when clinically indicated up to 24 months postoperatively | 
| Respiratory complications other than pneumonia | Radiographic imaging reports | Performed when clinically indicated up to 24 months postoperatively |