Recruiting

Esophagectomy

Sponsor:

Northwestern University

Code:

NCT05950438

Conditions

Esophagectomy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Esophagectomy

Study Details

Brief summary:

The primary goal of this study is to collect short-term and long-term health outcomes of a robotic transhiatal esophagectomy procedure. Clinical (or health) outcomes measure the effect of the procedure on your overall health status. During this procedure, the surgeon will remove all or part of your esophagus. We want to identify patients who will have this procedure. We will look at data elements before, during, and after your procedure to understand the impact of this surgery on your post-operative clinical outcomes.

Conditions

Esophagectomy

Study ID

NCT05950438

Start date

Jul 11, 2023

Status verified date

May, 2026

Completion date

May 25, 2028

Anticipated

Primary completion date

May 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients (18 years or older)
  • Patients undergoing elective esophagectomy for any indication
  • Patients who have already had an elective esophagectomy for any indication
  • Patients with consent providing capacity

Exclusion Criteria:

  • Patients undergoing emergent esophagectomy
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Vulnerable Populations

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Interventions

Esophagectomy

Esophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract.

Primary outcome measure

  • Number of Participants with Anastomotic Leak [ Time Frame: During first 3 months postop ]
  • Number of Participants with Esophageal Stricture [ Time Frame: During first 3 months postop ]
  • Number of Participants with Pneumonia [ Time Frame: During first 3 months postop ]
  • Number of Participants Requiring Ventilation >48 Hours [ Time Frame: During first 3 months postop ]
  • Number of Participants with Empyema [ Time Frame: During first 3 months postop ]
  • Number of Participants with Pulmonary Embolism [ Time Frame: During first 3 months postop ]
  • Number of Participants with Deep Venous Thrombosis [ Time Frame: During first 3 months postop ]
  • Number of Participants with Gastric Outlet Obstruction [ Time Frame: During first 3 months postop ]
  • Number of Participants with Stroke [ Time Frame: During first 3 months postop ]
  • Number of Participants with Atrial Fibrillation [ Time Frame: During first 3 months postop ]
  • Number of Participants with Vocal Cord Paralysis [ Time Frame: During first 3 months postop ]
  • Number of Participants with Myocardial Infarction [ Time Frame: During first 3 months postop ]
  • Number of Participants with Chylothorax [ Time Frame: During first 3 months postop ]
  • Number of Participants with Acute Renal Injury [ Time Frame: During first 3 months postop ]
  • Number of Participants with Wound Infections [ Time Frame: During first 3 months postop ]
  • Rates of Re-operation [ Time Frame: During first 3 months postop ]
  • Rates of Re-Admission [ Time Frame: During first 3 months postop ]
  • Number of Participants with Intensive Care Unit (ICU) Stay [ Time Frame: During first 3 months postop ]
  • Rates of Length of Hospital Stay [ Time Frame: Postoperative ]
  • Rates of 30-day Survival [ Time Frame: Postoperative ]
  • Rates of 90-day Survival Rates [ Time Frame: Postoperative ]

Central Contacts and Locations

Central contacts

Ankit Bharat, MD

312-926-7628ankit.bharat@northwestern.edu

Sara Krezalek, BSN

312-926-7577sara.krezalek@nm.org

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Ankit Bharat, MD

3129267628ankit.bharat@northwestern.edu

Sara Krezalek, BSN

3129267577sara.krezalek@nm.org

More Information

Sponsor

Northwestern University

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Robotic Transhiatal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-26.