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Procedure

Pyloroplasty During Esophagectomy

N/A
Waitlist Available
Led By James Luketich, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be willing to undergo esophagectomy for benign or malignant condition
Stomach is used as conduit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.
Awards & highlights

Study Summary

This trial is testing whether adding a pyloroplasty procedure (to drain the stomach) during esophagectomy (removal of the esophagus) is better than not adding the procedure.

Who is the study for?
This trial is for adults aged 18-85 who need an esophagectomy, a surgery to remove part of the esophagus, due to benign or malignant conditions. They must have an ECOG performance status of 0-2 and be able to use their stomach as a conduit post-surgery. It's not for those over 85 or under 18, with BMI >50, prior pylorus operations, previous gastric bypass or resection, liver issues, or if they can't tolerate surgery.Check my eligibility
What is being tested?
The study is testing whether adding a procedure called pyloroplasty (to help empty the stomach) during an esophagectomy offers benefits compared to just having the esophagectomy without this additional procedure. Participants are randomly assigned to either receive pyloroplasty or not during their surgery.See study design
What are the potential side effects?
Potential side effects from undergoing pyloroplasty may include digestive issues such as bloating and diarrhea since it affects how food passes from the stomach into the intestines. There could also be surgical risks like infection and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to have surgery to remove part of my esophagus.
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My surgery involved using my stomach to connect other organs.
Select...
I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
esophageal anastomosis leak requiring surgery
pneumonia
Secondary outcome measures
Aspiration as reported on radiographic imaging
Dysphagia as reported by patient using the Dysphagia scale
Esophageal anastomotic leak not requiring surgery
+12 more

Side effects data

From 2020 Phase 1 & 2 trial • 4 Patients • NCT01217060
100%
Dysphagia
100%
Fatigue
100%
Odynophagia
67%
Diarrhea
67%
Esophagitis
67%
Dyspepsia
33%
Lymphopenia
33%
Mucositis
33%
Anorexia
33%
Diaphoresis
33%
Sore throat
33%
Neuropathy
33%
Dysgeusia
33%
Cough
33%
Rash (Hand-Foot skin reaction)
33%
Weight loss
33%
Nausea
33%
Radiation Dermatitis
33%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel + 5-FU + Radiation + Surgery

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Esophagectomy without PyloroplastyExperimental Treatment1 Intervention
Esophagectomy without Pyloroplasty
Group II: Esophagectomy with PyloroplastyActive Control2 Interventions
Esophagectomy with Pyloroplasty
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esophagectomy
2016
Completed Phase 3
~4130

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,726 Previous Clinical Trials
16,305,603 Total Patients Enrolled
James Luketich, MD3.718 ReviewsPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
2 Previous Clinical Trials
112 Total Patients Enrolled
5Patient Review
This doctor and his team saved my life!!!

Media Library

Esophagectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03740542 — N/A
Esophagectomy Clinical Trial 2023: Esophagectomy Highlights & Side Effects. Trial Name: NCT03740542 — N/A
Esophagectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03740542 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies for enrollment in this research study?

"The trial is sourcing 140 individuals aged 18-85 who have already undergone oesophagectomy. In addition, to be eligible for the study, participants must be of any gender and meet an Eastern Cooperative Oncology Group (ECOG) performance status from 0-2 with a stomach conduit."

Answered by AI

Are there any openings still available for this scientific experiment?

"According to clinicaltrials.gov, the recruitment process for this medical trial is currently underway. It was initially posted on November 27th 2018 and last modified on January 21st 2022."

Answered by AI

Does this trial have an age restriction, and if so, do persons over 30 qualify?

"This clinical trial is available to those aged 18 and over, up to the age of 85."

Answered by AI

What is the primary objective of this clinical research endeavor?

"The main metric to be tracked in this medical trial over a 30 day period will focus on assessing the need for surgical repair due to esophageal anastomosis leak. Moreover, secondary data points such as radiographic imaging reports of aspiration, number of esophageal dilations performed, and quality-of-life assessments via SF36 questionnaires shall also be collected."

Answered by AI

How many individuals have elected to participate in this investigation?

"Indeed, the clinicaltrials.gov database reveals that this medical experiment is seeking volunteers. It was first posted on November 27th 2018 and most recently updated on January 21st 2022. The trial requires 140 participants from 1 centre to be enrolled."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
James Luketich 2018. "Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03740542.
~22 spots leftby May 2025
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