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Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

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ClinicalTrials.gov Identifier: NCT03740542
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
James Luketich, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE November 27, 2018
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • pneumonia [ Time Frame: 30 days postoperatively ]
    Defined as meeting 3 of 5 characteristics: fever, leukocytosis, chest x-ray (CXR) with infiltrate, positive culture from sputum, or treatment with antibiotics
  • esophageal anastomosis leak requiring surgery [ Time Frame: 30 days postoperatively ]
    Defined as a leak at the esophageal anastomosis site as evidenced by Barium Swallow Study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • Mortality [ Time Frame: 30 days ]
    Death within 30 days of surgery
  • Time to start oral diet [ Time Frame: Up to 24 months ]
    Number of days from surgery to starting oral diet
  • Quality of life assessment by completion of SF36 Quality of Life questionnaire [ Time Frame: Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery ]
    SF36 Quality of Life questionnaire
  • Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life (HRQL) measured by completion of GERD HRQL 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) questionnaire 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 [ Time Frame: Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery. ]
    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.
  • Nasogastric tube drainage measured in milliliters [ Time Frame: From date of surgery until date nasogastric tube is removed or date of discharge from hospital, whichever came first, assessed up to 24 months. ]
    Measured in milliliters
  • Replacement of nasogastric tube reported as number of days from tube removal to reinsertion [ Time Frame: Up to 24 months ]
    Number of days from nasogastric tube removal to reinsertion
  • Esophageal dilations reported as the number of esophageal dilations performed [ Time Frame: Up to 24 months ]
    Number of esophageal dilations performed
  • Length of hospital stay [ Time Frame: From date of surgery until the date of discharge from hospital, assessed up to 24 months. ]
    Number of days in hospital
  • Aspiration as reported on radiographic imaging [ Time Frame: Performed when clinically indicated up to 24 months postoperatively ]
    Radiographic imaging reports
  • Gastric outlet obstruction as reported on barium swallow reports [ Time Frame: Performed when clinically indicated up to 24 months postoperatively ]
    Barium swallow reports
  • Re-admission to hospital [ Time Frame: Up to 24 months postoperatively ]
    Number of days from hospital discharge to re-admission
  • Unexpected return to the Operating Room [ Time Frame: Up to 24 months postoperatively ]
    Procedure performed in the Operating Room
  • Esophageal anastomotic leak not requiring surgery [ Time Frame: Performed when clinically indicated up to 24 months postoperatively ]
    Barium swallow reports
  • Respiratory complications other than pneumonia [ Time Frame: Performed when clinically indicated up to 24 months postoperatively ]
    Radiographic imaging reports
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
Official Title  ICMJE A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophagectomy
Intervention  ICMJE
  • Procedure: Esophagectomy
    Surgical removal of part of esophagus
  • Procedure: Pyloroplasty
    pyloric drainage procedure
Study Arms  ICMJE
  • Active Comparator: Esophagectomy with Pyloroplasty
    Esophagectomy with Pyloroplasty
    Interventions:
    • Procedure: Esophagectomy
    • Procedure: Pyloroplasty
  • Experimental: Esophagectomy without Pyloroplasty
    Esophagectomy without Pyloroplasty
    Intervention: Procedure: Esophagectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2023
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie Ward, BSN 412-647-8583 wardj@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03740542
Other Study ID Numbers  ICMJE PRO18010137
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Undecided
Responsible Party James Luketich, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Luketich, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP