Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

University of Pittsburgh

Status: Active, not recruiting

Conditions: Esophagectomy

Treatments: Procedure: Pyloroplasty; Procedure: Esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03740542

STUDY19020375

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 143 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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
• Previous gastric bypass
• 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
• Liver cirrhosis or liver failure at physician's discretion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Esophagectomy with Pyloroplasty

Active Comparator group

Description:

Esophagectomy with Pyloroplasty

Treatment:

Procedure: Esophagectomy

Procedure: Pyloroplasty

Esophagectomy without Pyloroplasty

Experimental group

Description:

Esophagectomy without Pyloroplasty

Treatment:

Procedure: Esophagectomy