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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 : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
James Luketich, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Esophagectomy Procedure: Esophagectomy Procedure: Pyloroplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : January 30, 2023

Arm Intervention/treatment
Active Comparator: Esophagectomy with Pyloroplasty
Esophagectomy with Pyloroplasty
Procedure: Esophagectomy
Surgical removal of part of esophagus

Procedure: Pyloroplasty
pyloric drainage procedure

Experimental: Esophagectomy without Pyloroplasty
Esophagectomy without Pyloroplasty
Procedure: Esophagectomy
Surgical removal of part of esophagus




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Death within 30 days of surgery

  2. Time to start oral diet [ Time Frame: Up to 24 months ]
    Number of days from surgery to starting oral diet

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. Esophageal dilations reported as the number of esophageal dilations performed [ Time Frame: Up to 24 months ]
    Number of esophageal dilations performed

  9. 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

  10. Aspiration as reported on radiographic imaging [ Time Frame: Performed when clinically indicated up to 24 months postoperatively ]
    Radiographic imaging reports

  11. Gastric outlet obstruction as reported on barium swallow reports [ Time Frame: Performed when clinically indicated up to 24 months postoperatively ]
    Barium swallow reports

  12. Re-admission to hospital [ Time Frame: Up to 24 months postoperatively ]
    Number of days from hospital discharge to re-admission

  13. Unexpected return to the Operating Room [ Time Frame: Up to 24 months postoperatively ]
    Procedure performed in the Operating Room

  14. Esophageal anastomotic leak not requiring surgery [ Time Frame: Performed when clinically indicated up to 24 months postoperatively ]
    Barium swallow reports

  15. Respiratory complications other than pneumonia [ Time Frame: Performed when clinically indicated up to 24 months postoperatively ]
    Radiographic imaging reports



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740542


Contacts
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Contact: Julie Ward, BSN 412-647-8583 wardj@upmc.edu

Locations
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United States, Pennsylvania
Department of Cardiothoracic Surgery Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie Ward, BSN    412-647-8583    wardj@upmc.edu   
Principal Investigator: James Luketich, MD         
Sub-Investigator: Neil Christie, MD         
Sub-Investigator: Matthew Schuchert, MD         
Sub-Investigator: Arjun Pennathur, MD         
Sub-Investigator: Ryan Levy, MD         
Sub-Investigator: Jason Lamb, MD         
Sub-Investigator: Rajeev Dhupar, MD         
Principal Investigator: Inderpal Sarkaria, MD         
Sub-Investigator: Manuel Villa Sanchez, MD         
Sub-Investigator: Nicholas Baker, MD         
Sub-Investigator: Omar Awais, MD         
Sub-Investigator: William Gooding         
Sub-Investigator: Olugbenga Okusanya, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: James Luketich, MD University of Pittsburgh

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Responsible Party: James Luketich, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03740542     History of Changes
Other Study ID Numbers: PRO18010137
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No