Pyloroplasty During Esophagectomy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether adding a pyloroplasty, a procedure that aids stomach drainage, during an esophagectomy (surgery to remove part of the esophagus) affects outcomes compared to not adding it. The study divides participants into two groups: one group will undergo esophagectomy with pyloroplasty, and the other without it. Individuals requiring an esophagectomy for either non-cancerous or cancerous conditions, with their stomach used as a conduit, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially enhance surgical outcomes for future patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pyloroplasty, performed during surgery to remove part of the esophagus, is generally safe. Studies have found that it helps avoid additional procedures to manage the stomach's opening, indicating good patient tolerance.
Pyloroplasty is also used for other stomach issues, such as gastroparesis, where the stomach empties slowly. It boasts a high success rate of nearly 90% for these conditions. However, some research questions its necessity during esophagus surgery, as it might not improve stomach emptying and could cause other issues.
Overall, pyloroplasty's safety appears strong, but its necessity during esophagus surgery remains debated.12345Why are researchers excited about this trial?
Researchers are excited about the use of pyloroplasty during esophagectomy because it offers a potential improvement over the traditional approach of esophagectomy without pyloroplasty. While standard esophagectomy aims to remove cancerous tissue in the esophagus, adding pyloroplasty helps by surgically widening the pylorus, the opening between the stomach and small intestine. This can enhance gastric emptying and reduce postoperative complications like delayed gastric emptying. By improving the digestive process, pyloroplasty during esophagectomy could lead to better recovery outcomes and quality of life for patients.
What evidence suggests that pyloroplasty during esophagectomy could be effective?
This trial will compare esophagectomy with pyloroplasty to esophagectomy without it. Research has shown that pyloroplasty, a procedure that aids in stomach emptying, can be beneficial during esophagectomy, which involves removing part of the esophagus. Studies have found that pyloroplasty reduces the need for additional procedures to open the stomach valve post-surgery. Patients without pyloroplasty might lose more weight due to these additional procedures. The procedure is generally considered safe and can aid recovery. However, some research suggests disagreement on its necessity during surgery.12456
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