NCT04219410

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

3.7 years

First QC Date

January 3, 2020

Last Update Submit

January 3, 2020

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Hospital length of stay

    Hospital length of stay

    Through study completion, an average of 2.9 years

Secondary Outcomes (6)

  • Intensive care unit length of stay

    Through study completion, an average of 2.9 years

  • Feeding tube placement

    Intra-operatively

  • Number of patients with inpatient mortality

    Through study completion, an average of 2.9 years

  • 90-day total mortality

    90 days post discharge

  • Number of patients with hospital readmission within 30 days

    30 days post discharge

  • +1 more secondary outcomes

Study Arms (1)

Cases

Patients who underwent minimally invasive esophagectomy with this novel procedure at Kaiser Permanente, Northern California, Oakland Medical Center

Procedure: Fully minimally invasive esophagectomy

Interventions

Fully minimally invasive esophagectomyPROCEDURE

Esophagectomy using a novel fully minimally invasive approach

Cases

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Andrew Avins, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

January 1, 2013

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share