NCT03740542

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Nov 2018Mar 2027

First Submitted

Initial submission to the registry

August 20, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

August 20, 2018

Last Update Submit

April 9, 2026

Conditions

Esophagectomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • Mortality

    30 days

  • Time to start oral diet

    Up to 24 months

  • 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

  • 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.

  • 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.

  • +10 more secondary outcomes

Study Arms (2)

Esophagectomy with Pyloroplasty

ACTIVE COMPARATOR

Esophagectomy with Pyloroplasty

Procedure: EsophagectomyProcedure: Pyloroplasty

Esophagectomy without Pyloroplasty

EXPERIMENTAL

Esophagectomy without Pyloroplasty

Procedure: Esophagectomy

Interventions

EsophagectomyPROCEDURE

Surgical removal of part of esophagus

Esophagectomy with PyloroplastyEsophagectomy without Pyloroplasty
PyloroplastyPROCEDURE

pyloric drainage procedure

Esophagectomy with Pyloroplasty

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

  • 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.

    PMID: 41413794DERIVED

MeSH Terms

Interventions

Esophagectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • James Luketich, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2018

First Posted

November 14, 2018

Study Start

November 27, 2018

Primary Completion

February 14, 2023

Study Completion (Estimated)

March 1, 2027

Last Updated

April 14, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Undecided

Locations

US(2)