Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophagectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Esophagectomy with Pyloroplasty

Group Type ACTIVE_COMPARATOR

Esophagectomy

Intervention Type PROCEDURE

Surgical removal of part of esophagus

Pyloroplasty

Intervention Type PROCEDURE

pyloric drainage procedure

Esophagectomy without Pyloroplasty

Group Type EXPERIMENTAL

Esophagectomy

Intervention Type PROCEDURE

Surgical removal of part of esophagus

Interventions

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Esophagectomy

Surgical removal of part of esophagus

Intervention Type PROCEDURE

Pyloroplasty

pyloric drainage procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No