Assessment of a Modified Minimally Invasive Esophagectomy

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT04219410
• Collaborator: (none)
• Enrollment: 142
• Actual Duration (Months): 44

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Procedure: Fully minimally invasive esophagectomy

Study Design

• Study Type: Observational
• Actual Enrollment: 142 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Assessment of a Modified Minimally Invasive Esophagectomy
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 31, 2016
• Actual Study Completion Date: Aug 31, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Hospital length of stay [Through study completion, an average of 2.9 years]

   Hospital length of stay

Secondary Outcome Measures

1. Intensive care unit length of stay [Through study completion, an average of 2.9 years]

   Intensive care unit length of stay

2. Feeding tube placement [Intra-operatively]

   Feeding tube placement

3. Number of patients with inpatient mortality [Through study completion, an average of 2.9 years]

   Number of patients with inpatient mortality

4. 90-day total mortality [90 days post discharge]

   90-day total mortality

5. Number of patients with hospital readmission within 30 days [30 days post discharge]

   Number of patients with hospital readmission within 30 days

6. Number of patients with complications [Hospital stay and 30 days post discharge]

   Number of patients with medical and surgical complications both inpatient and post-discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kaiser Permanente

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andy Avins, Senior Research Scientist, Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT04219410
• Other Study ID Numbers: 1279152-4
• First Posted: Jan 7, 2020
• Last Update Posted: Jan 7, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 7, 2020