143 Participants Needed

Pyloroplasty During Esophagectomy

Recruiting at 1 trial location
JW
Overseen ByJulie Ward, BSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JL

James Luketich, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to have surgery to remove part of my esophagus.
My surgery involved using my stomach to connect other organs.
I am able to care for myself and perform daily activities.

Exclusion Criteria

I have had surgery on the part of my stomach that connects to my small intestine.
I cannot undergo surgery due to my health condition.
My doctor has diagnosed me with liver cirrhosis or liver failure.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo esophagectomy with or without pyloroplasty

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for complications such as pneumonia and esophageal anastomosis leak

30 days

Follow-up

Participants are monitored for long-term outcomes including quality of life and complications

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Esophagectomy
  • Pyloroplasty
Trial Overview 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.
How Is the Trial Designed?
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

Esophagectomy is already approved in European Union, United States, Japan, China for the following indications:

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Approved in European Union as Esophagectomy for:
  • Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
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Approved in United States as Esophagectomy for:
  • Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
  • Other esophageal cancers
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Approved in Japan as Esophagectomy for:
  • Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
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Approved in China as Esophagectomy for:
  • Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+
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