Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Esophagectomy
• Intervention / Treatment: Procedure: Esophagectomy

Detailed Description

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. Different surgical approaches and techniques have been developed, including open (transthoracic or transhiatal), minimally invasive (video-assisted thoracoscopic surgery or robotic-assisted), and hybrid approaches. These techniques may yield different clinical outcomes, and there is still ongoing debate regarding the optimal approach. Nevertheless, minimally invasive approaches, including robotic esophagectomy, are generally preferred given the lower morbidity. This prospective clinical registry aims to investigate outcomes of elective robotic transhiatal esophagectomy, the preferred approach at Northwestern Memorial Hospital, for adult patients undergoing this procedure. By collecting clinical and demographic data prospectively, we hope to identify factors that contribute to improved outcomes and guide future surgical practice.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Ankit Bharat, MD; Phone Number: 312-926-7628; Email: ankit.bharat@northwestern.edu
• Study Contact Backup: Name: Sara Krezalek, BSN; Phone Number: 312-926-7577; Email: sara.krezalek@nm.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Sara Krezalek, BSN; Phone Number: 3129267577; Email: sara.krezalek@nm.org
      • Contact: Ankit Bharat, MD; Phone Number: 3129267628; Email: ankit.bharat@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants will be identified in the Thoracic Surgery clinic or in the inpatient setting based on the surgeon's expertise who need to undergo an elective esophagectomy procedure.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time of Surgery	Length of Surgery	Intraoperative
Rates of Blood Loss	Did the Participant Lose Any Blood During the Surgery	Intraoperative
Number of Participants with Conversion Rates to Open Esophagectomy		Intraoperative
Number of Participants with Lymph nodes in the Final Specimen	Pathological Variables	Intraoperative
Number of Participants with Proximal and Distal Margins	Pathological Variables	Intraoperative

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Ankit Bharat, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): May 25, 2028
• Study Completion (Estimated): May 25, 2028

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Robotic Transhiatal
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Digestive System Surgical Procedures; Esophagectomy
• Other Study ID Numbers: STU00219267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No