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NCT Number: NCT03740542

Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Esophagectomy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiothoracic Surgery, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophagectomy

Procedure

Surgical removal of part of esophagus

Pyloroplasty

Procedure

pyloric drainage procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2027
First posted
Nov 14, 2018
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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