Clinical trial NCT03740542: Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
Official title: A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Esophagectomy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: pneumonia
timeFrame: 30 days postoperatively
measure: esophageal anastomosis leak requiring surgery
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Time to start oral diet
timeFrame: Up to 24 months
measure: Quality of life assessment by completion of SF36 Quality of Life questionnaire
timeFrame: Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery
measure: Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life (HRQL) measured by completion of GERD HRQL questionnaire
timeFrame: Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.
measure: Dysphagia as reported by patient using the Dysphagia scale
timeFrame: Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.
measure: Nasogastric tube drainage measured in milliliters
timeFrame: From date of surgery until date nasogastric tube is removed or date of discharge from hospital, whichever came first, assessed up to 24 months.
measure: Replacement of nasogastric tube reported as number of days from tube removal to reinsertion
timeFrame: Up to 24 months
measure: Esophageal dilations reported as the number of esophageal dilations performed
timeFrame: Up to 24 months
measure: Length of hospital stay
timeFrame: From date of surgery until the date of discharge from hospital, assessed up to 24 months.
measure: Aspiration as reported on radiographic imaging
timeFrame: Performed when clinically indicated up to 24 months postoperatively
measure: Gastric outlet obstruction as reported on barium swallow reports
timeFrame: Performed when clinically indicated up to 24 months postoperatively
measure: Re-admission to hospital
timeFrame: Up to 24 months postoperatively
measure: Unexpected return to the Operating Room
timeFrame: Up to 24 months postoperatively
measure: Esophageal anastomotic leak not requiring surgery
timeFrame: Performed when clinically indicated up to 24 months postoperatively
measure: Respiratory complications other than pneumonia
timeFrame: Performed when clinically indicated up to 24 months postoperatively
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Department of Cardiothoracic Surgery
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: James Luketich, MD
role: PRINCIPAL_INVESTIGATOR
References: