Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/20/2019 |
| Start Date: | November 27, 2018 |
| End Date: | January 30, 2023 |
| Contact: | Julie Ward, BSN |
| Email: | wardj@upmc.edu |
| Phone: | 412-647-8583 |
A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
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.
pyloroplasty procedure versus no pyloroplasty procedure during the performance of
esophagectomy. Pyloroplasty is a type of pyloric drainage procedure.
Patients selected for enrollment in this study will be adults (18-85 years of age) that have
been scheduled for exploration, and possible esophagectomy. Prior to surgery, patients will
be randomized to one of two groups. Group A will have a pyloroplasty performed as part of the
esophagectomy procedure. Group B will not have a pyloroplasty performed. Postoperative
patient outcomes will be assessed for 24 months.
been scheduled for exploration, and possible esophagectomy. Prior to surgery, patients will
be randomized to one of two groups. Group A will have a pyloroplasty performed as part of the
esophagectomy procedure. Group B will not have a pyloroplasty performed. Postoperative
patient outcomes will be assessed for 24 months.
Inclusion Criteria:
- Subjects must be willing to undergo esophagectomy for benign or malignant condition
- Women and men 18-85 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Stomach is used as conduit
Exclusion Criteria:
- Previous operations of the pylorus
- Previous gastric resection
- Patients who are unable to tolerate surgery
- Participants may be enrolled and randomized on the study but may be excluded at the
time of the surgery because of findings by the surgeon that preclude performing
esophagectomy, or using stomach as a conduit or findings which preclude following the
randomized arm.
- Age <18 years of age or > 85 years of age
- BMI > 50
We found this trial at
1
site
Pittsburgh, Pennsylvania 15232
Principal Investigator: James Luketich, MD
Phone: 412-647-8583
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