Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Esophagectomy
• Intervention / Treatment: Procedure: Esophagectomy; Procedure: Pyloroplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Department of Cardiothoracic Surgery
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Esophagectomy with Pyloroplasty	Procedure: Esophagectomy; Surgical removal of part of esophagus; Procedure: Pyloroplasty; pyloric drainage procedure
Experimental: Esophagectomy without Pyloroplasty	Procedure: Esophagectomy; Surgical removal of part of esophagus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: James Luketich, MD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): February 14, 2023
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Digestive System Surgical Procedures; Esophagectomy
• Other Study ID Numbers: STUDY19020375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No