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Should surgeons add a pyloric drainage step during esophagectomy? new trial aims to find out.

NCT ID NCT03740542

Knowledge-focused Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two surgical approaches for people having their esophagus removed (esophagectomy): one group gets the standard surgery plus an extra drainage procedure on the stomach (pyloroplasty), and the other gets the standard surgery alone. The goal is to see if the extra step reduces serious complications like pneumonia and leaks where the esophagus is reconnected. About 143 adults aged 18–85 are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pyloroplasty (a surgical drainage procedure on the pylorus)
What this could lead to
If successful, this could show that adding pyloroplasty during esophagectomy reduces complications like pneumonia and leaks, improving recovery.
What could go wrong
This is a relatively small, single-center surgical trial. The benefit may be small or not apply to all patients, and surgery always carries risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

143 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophagectomy

Contacts and locations

Locations

  • Department of Cardiothoracic Surgery

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15213, United States

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