EsophagectomyNCT03740542
Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
A study testing Esophagectomy and Pyloroplasty in people with Esophagectomy, run by University of Pittsburgh at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophagectomy
- What is being tested?
- Esophagectomy and Pyloroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Nov 2018to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Medical Center Presbyterian-Shadyside Hospital
Pittsburgh, Pennsylvania, 15213
Department of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase III Randomized Trial of 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.
Read the 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.
- Conditions
- Esophagectomy
- Being tested
- Esophagectomy, Pyloroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
Surgical removal of part of esophagus
PyloroplastyProcedure or surgery
pyloric drainage procedure
| Study group | Role | What they receive |
|---|---|---|
| Esophagectomy with Pyloroplasty | Active comparator | Esophagectomy with Pyloroplasty Receives: Procedure: Esophagectomy; Procedure: Pyloroplasty |
| Esophagectomy without Pyloroplasty | Experimental | Esophagectomy without Pyloroplasty Receives: Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pneumonia
Defined as meeting 3 of 5 characteristics: fever, leukocytosis, chest x-ray (CXR) with infiltrate, positive culture from sputum, or treatment with antibiotics
Measured: 30 days postoperatively
esophageal anastomosis leak requiring surgery
Defined as a leak at the esophageal anastomosis site as evidenced by Barium Swallow Study.
Measured: 30 days postoperatively
Secondary outcomes (15)
Mortality
Death within 30 days of surgery
Measured: 30 days
Time to start oral diet
Number of days from surgery to starting oral diet
Measured: Up to 24 months
Quality of life assessment by completion of SF36 Quality of Life questionnaire
SF36 Quality of Life questionnaire
Measured: 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) 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.
Measured: 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
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.
Measured: Prior to esophagectomy, at the first postoperative visit, and 4, 6, and 12 months after surgery.
Nasogastric tube drainage measured in milliliters
Measured in milliliters
Measured: From date of surgery until date nasogastric tube is removed or date of discharge from hospital, whichever came first, assessed up to 24 months.
Replacement of nasogastric tube reported as number of days from tube removal to reinsertion
Number of days from nasogastric tube removal to reinsertion
Measured: Up to 24 months
Esophageal dilations reported as the number of esophageal dilations performed
Number of esophageal dilations performed
Measured: Up to 24 months
Length of hospital stay
Number of days in hospital
Measured: From date of surgery until the date of discharge from hospital, assessed up to 24 months.
Aspiration as reported on radiographic imaging
Radiographic imaging reports
Measured: Performed when clinically indicated up to 24 months postoperatively
Gastric outlet obstruction as reported on barium swallow reports
Barium swallow reports
Measured: Performed when clinically indicated up to 24 months postoperatively
Re-admission to hospital
Number of days from hospital discharge to re-admission
Measured: Up to 24 months postoperatively
Unexpected return to the Operating Room
Procedure performed in the Operating Room
Measured: Up to 24 months postoperatively
Esophageal anastomotic leak not requiring surgery
Barium swallow reports
Measured: Performed when clinically indicated up to 24 months postoperatively
Respiratory complications other than pneumonia
Radiographic imaging reports
Measured: Performed when clinically indicated up to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start27 Nov 2018
- Primary completion14 Feb 2023
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Luketich, University of Pittsburgh
- Investigators
- James Luketich, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740542
- Sponsor's protocol ID
- STUDY19020375
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2018
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Publications
Luketich JD, Sarkaria ID, Levy RM, Alicuben ET, Gooding WE, Davis PL, Awais O, Christie NA, Levesque RL, Ward J, Ryan JP, Schuchert MJ, Pennathur A. A Phase III Randomized Controlled Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Minimally Invasive Esophagectomy or Robot-assisted Minimally Invasive Esophagectomy. Ann Surg. 2026 Apr 1;283(4):569-580. doi: 10.1097/SLA.0000000000006997. Epub 2025 Dec 19.
PubMed 41413794
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy
- ClinicalTrials.gov ID
- NCT03740542
- Acronym / sponsor ID
- STUDY19020375
- Conditions
- Esophagectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esophagectomy with Pyloroplasty | Active comparator | Procedure: Esophagectomy, Procedure: PyloroplastyEsophagectomy with Pyloroplasty |
| Esophagectomy without Pyloroplasty | Experimental | Procedure: EsophagectomyEsophagectomy without Pyloroplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagectomySurgical removal of part of esophagus | Procedure or surgery | Esophagectomy with Pyloroplasty, Esophagectomy without Pyloroplasty |
| Pyloroplastypyloric drainage procedure | Procedure or surgery | Esophagectomy with Pyloroplasty |
Primary outcome
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.
15 secondary outcomes
Mortality
Time frame: 30 days
Time to start oral diet
Time frame: Up to 24 months
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
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.
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.
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.
Replacement of nasogastric tube reported as number of days from tube removal to reinsertion
Time frame: Up to 24 months
Esophageal dilations reported as the number of esophageal dilations performed
Time frame: Up to 24 months
Length of hospital stay
Time frame: From date of surgery until the date of discharge from hospital, assessed up to 24 months.
Aspiration as reported on radiographic imaging
Time frame: Performed when clinically indicated up to 24 months postoperatively
Gastric outlet obstruction as reported on barium swallow reports
Time frame: Performed when clinically indicated up to 24 months postoperatively
Re-admission to hospital
Time frame: Up to 24 months postoperatively
Unexpected return to the Operating Room
Time frame: Up to 24 months postoperatively
Esophageal anastomotic leak not requiring surgery
Time frame: Performed when clinically indicated up to 24 months postoperatively
Respiratory complications other than pneumonia
Time frame: Performed when clinically indicated up to 24 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 41413794Luketich JD, Sarkaria ID, Levy RM, Alicuben ET, Gooding WE, Davis PL, Awais O, Christie NA, Levesque RL, Ward J, Ryan JP, Schuchert MJ, Pennathur A. A Phase III Randomized Controlled Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Minimally Invasive Esophagectomy or Robot-assisted Minimally Invasive Esophagectomy. Ann Surg. 2026 Apr 1;283(4):569-580. doi: 10.1097/SLA.0000000000006997. Epub 2025 Dec 19.
- Individual participant dataSharing planned: No. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Luketich, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagectomy and Pyloroplasty in people with Esophagectomy, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pneumonia (time frame: 30 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.