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

Must not have

Previous operations of the pylorus

Age <18 years of age or > 85 years of age

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

No Placebo-Only Group

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.

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.

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.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on the part of my stomach that connects to my small intestine.

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I am younger than 18 or older than 85.

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I cannot undergo surgery due to my health condition.

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I have had part of my stomach surgically removed.

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I have had a gastric bypass surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery

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.