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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophagectomy with Pyloroplasty | Active Comparator | Esophagectomy with Pyloroplasty |
|
| Esophagectomy without Pyloroplasty | Experimental | Esophagectomy without Pyloroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagectomy | Procedure | Surgical removal of part of esophagus |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Luketich, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital | Pittsburgh | Pennsylvania | 15213 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41413794 | Derived | Luketich JD, Sarkaria ID, Levy RM, Alicuben ET, Gooding WE, Davis PL, Awais O, Christie NA, Levesque RL, Ward J, Ryan JP, Schuchert MJ, Pennathur A. A Phase III Randomized Controlled Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Minimally Invasive Esophagectomy or Robot-assisted Minimally Invasive Esophagectomy. Ann Surg. 2026 Apr 1;283(4):569-580. doi: 10.1097/SLA.0000000000006997. Epub 2025 Dec 19. |
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| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Pyloroplasty | Procedure | pyloric drainage procedure |
|
| 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 |
| Department of Cardiothoracic Surgery |
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |