Pyloroplasty During Esophagectomy
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo esophagectomy with or without pyloroplasty
Postoperative Monitoring
Participants are monitored for complications such as pneumonia and esophageal anastomosis leak
Follow-up
Participants are monitored for long-term outcomes including quality of life and complications
What Are the Treatments Tested in This Trial?
Interventions
- Esophagectomy
- Pyloroplasty
Esophagectomy is already approved in European Union, United States, Japan, China for the following indications:
- Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
- Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
- Other esophageal cancers
- Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
- 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