Assessment of a Modified Minimally Invasive Esophagectomy

This is a retrospective case series of a novel fully minimally invasive esophagectomy procedure for patients with primary esophageal cancer.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: Fully minimally invasive esophagectomy

• Study Type: Observational
• Enrollment (Actual): 142

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive sample of all patients undergoing the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center during the study period

Description

Inclusion Criteria:

• patient with primary esophageal cancer of any cell type
• underwent the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center by one of the study author-surgeons

Exclusion Criteria:

• non-elective procedure
• less than 90 days of post-discharge follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients who underwent minimally invasive esophagectomy with this novel procedure at Kaiser Permanente, Northern California, Oakland Medical Center	Procedure: Fully minimally invasive esophagectomy; Esophagectomy using a novel fully minimally invasive approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Hospital length of stay	Through study completion, an average of 2.9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care unit length of stay	Intensive care unit length of stay	Through study completion, an average of 2.9 years
Feeding tube placement	Feeding tube placement	Intra-operatively
Number of patients with inpatient mortality	Number of patients with inpatient mortality	Through study completion, an average of 2.9 years
90-day total mortality	90-day total mortality	90 days post discharge
Number of patients with hospital readmission within 30 days	Number of patients with hospital readmission within 30 days	30 days post discharge
Number of patients with complications	Number of patients with medical and surgical complications both inpatient and post-discharge	Hospital stay and 30 days post discharge

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Andrew Avins, MD, MPH, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1279152-4

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