Assessment of a Modified Minimally Invasive Esophagectomy | NCT04219410

Studies
Assessment of a Modified Minimally Invasive Esophagectomy

NCT04219410

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

Jan 7, 2020Actual

Enrollment

142Actual

Phase

Not provided

Conditions

Esophageal Cancer

Interventions

Fully minimally invasive esophagectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Aug 31, 2016Actual

Completion Date

Aug 31, 2016Actual

First Submitted Date

Jan 3, 2020

First Submission Date that Met QC Criteria

Jan 3, 2020

First Posted Date

Jan 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2020

Last Update Posted Date

Jan 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fully minimally invasive esophagectomy	Procedure	Esophagectomy using a novel fully minimally invasive approach	Cases

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Avins, MD, MPH	Kaiser Permanente	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided