Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

Esophagectomy Clinical Trial

Official title:

A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03740542
• Other study ID #: STUDY19020375
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: January 2025
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagectomy

Intervention

Procedure:
• Esophagectomy
Surgical removal of part of esophagus
• Pyloroplasty
pyloric drainage procedure

Locations

Country	Name	City	State
United States	Department of Cardiothoracic Surgery	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pneumonia	Defined as meeting 3 of 5 characteristics: fever, leukocytosis, chest x-ray (CXR) with infiltrate, positive culture from sputum, or treatment with antibiotics	30 days postoperatively
Primary	esophageal anastomosis leak requiring surgery	Defined as a leak at the esophageal anastomosis site as evidenced by Barium Swallow Study.	30 days postoperatively
Secondary	Mortality	Death within 30 days of surgery	30 days
Secondary	Time to start oral diet	Number of days from surgery to starting oral diet	Up to 24 months
Secondary	Quality of life assessment by completion of SF36 Quality of Life questionnaire	SF36 Quality of Life questionnaire	Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery
Secondary	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.	Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.
Secondary	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.	Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.
Secondary	Nasogastric tube drainage measured in milliliters	Measured in milliliters	From date of surgery until date nasogastric tube is removed or date of discharge from hospital, whichever came first, assessed up to 24 months.
Secondary	Replacement of nasogastric tube reported as number of days from tube removal to reinsertion	Number of days from nasogastric tube removal to reinsertion	Up to 24 months
Secondary	Esophageal dilations reported as the number of esophageal dilations performed	Number of esophageal dilations performed	Up to 24 months
Secondary	Length of hospital stay	Number of days in hospital	From date of surgery until the date of discharge from hospital, assessed up to 24 months.
Secondary	Aspiration as reported on radiographic imaging	Radiographic imaging reports	Performed when clinically indicated up to 24 months postoperatively
Secondary	Gastric outlet obstruction as reported on barium swallow reports	Barium swallow reports	Performed when clinically indicated up to 24 months postoperatively
Secondary	Re-admission to hospital	Number of days from hospital discharge to re-admission	Up to 24 months postoperatively
Secondary	Unexpected return to the Operating Room	Procedure performed in the Operating Room	Up to 24 months postoperatively
Secondary	Esophageal anastomotic leak not requiring surgery	Barium swallow reports	Performed when clinically indicated up to 24 months postoperatively
Secondary	Respiratory complications other than pneumonia	Radiographic imaging reports	Performed when clinically indicated up to 24 months postoperatively