Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

N/AActive Not RecruitingNCT03740542

University of Pittsburgh143 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

143

Conditions

Esophagectomy

Interventions

EsophagectomyPROCEDURE

Surgical removal of part of esophagus

PyloroplastyPROCEDURE

pyloric drainage procedure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

pneumonia

Defined as meeting 3 of 5 characteristics: fever, leukocytosis, chest x-ray (CXR) with infiltrate, positive culture from sputum, or treatment with antibiotics

Time frame: 30 days postoperatively

esophageal anastomosis leak requiring surgery

Defined as a leak at the esophageal anastomosis site as evidenced by Barium Swallow Study.

Time frame: 30 days postoperatively

Secondary Outcomes

Mortality

Death within 30 days of surgery

Time frame: 30 days

Time to start oral diet

Number of days from surgery to starting oral diet

Time frame: Up to 24 months

Quality of life assessment by completion of SF36 Quality of Life questionnaire

SF36 Quality of Life questionnaire

Time frame: Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery

Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life (HRQL) measured by completion of GERD HRQL questionnaire

Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life (HRQL) questionnaire prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.

Time frame: Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.

Dysphagia as reported by patient using the Dysphagia scale

Dysphagia scale measures swallowing difficulty on a scale of 1-5. (1=no difficulty swallowing; 2=difficulty swallowing hard solids; 3=difficulty swallowing soft solids; 4=difficulty swallowing liquids; 5=unable to swallow anything. A lower score represents a better outcome.

Data from ClinicalTrials.gov

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