NCT04206696

Brief Summary

Minimally invasive oesophagectomy is a technically demanding procedure; thus, the learning curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy procedure should be contrasted with the open procedure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 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

July 1, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

6.1 years

First QC Date

December 15, 2019

Last Update Submit

December 19, 2019

Conditions

Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (5)

  • bleeding volume

    bleeding volume in milliliter

    Between July 2010 and August 2016

  • operation time

    operation time in minutes

    Between July 2010 and August 2016

  • complications

    complications in percentage

    Between July 2010 and August 2016

  • mortality

    mortality in percentage

    Between July 2010 and August 2016

  • lymphadenectomy

    lymphadenectomy in number

    Between July 2010 and August 2016

Secondary Outcomes (2)

  • 2-year overall survival rate

    Between August 2016 and August 2018

  • 2-year disease-free survival

    Between August 2016 and August 2018

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy.

You may qualify if:

  • oesophageal cancer diagnosed by endoscopy and biopsy good cardiopulmonary function to tolerate surgery

You may not qualify if:

  • poor cardiopulmonary function distant metastasis T4 with little possibility of radical resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Xiaogang Zhao, Doctor

    The Second Hospital of Shandong University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 20, 2019

Study Start

July 1, 2010

Primary Completion

August 1, 2016

Study Completion

January 1, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12