NCT02448966

Brief Summary

Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection remains the most effective method for this malignant disease. VATS esophagectomy has become more and more popular in China and around the world. Although VATS esophagectomy has been proven to be effective in preventing respiratory complications, there is still no ample evidences to demonstrate that VATS esophagectomy is as effective as traditional three-incision esophagectomy in lymph node dissection and is equal or superior in long-term survival. The purpose of this large scale prospective observational study is to compare the minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision esophagectomy in lymph node dissection, postoperative recovery, postoperative complications, and long-term survival.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

May 8, 2015

Last Update Submit

May 19, 2015

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Long term survival

    5 years

Secondary Outcomes (2)

  • Disease free survival

    5 years

  • Postoperative complications

    3 years

Study Arms (2)

Traditional open esophagectomy

Treated by traditional three-incision esophagectomy in the centers with enough experience in esophagectomy via right thoracotomy and the volume ≧50 cases each year.

Procedure: open esophagectomy

Minimally invasive eophagectomy

treated by minimally invasive thorascopic/laparoscopic esophagectomy in the centers with enough experience in VATS esophagectomy and the volume≧50 cases each year.

Procedure: Minimally invasive esophagectomy

Interventions

open esophagectomyPROCEDURE
Traditional open esophagectomy
Minimally invasive esophagectomyPROCEDURE
Minimally invasive eophagectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cT1b-3N0-1M0 thoracic esophageal cancer.

You may qualify if:

  • Patients with histologically proven squamous cell esophageal cancer, without any previous anti-tumor therapy;
  • Preoperative clinical TNM stage:cT1b-3N0-1M0;
  • Adequate cardiopulmonary, liver, brain and kidney function which can tolerate the esophagectomy either via traditional tree-incision or minimally invasive thorascopic/laparoscopic esophagectomy;
  • Preoperative assessment by CT and EUS is fit for minimally invasive thorascopic/laparoscopic esophagectomy;
  • Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail.

You may not qualify if:

  • Previous use of anti-cancer therapy;
  • Preoperative clinical TNM stage: N2-3 or M1;
  • Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
  • Previous malignancy history;
  • Unwilling to participate the clinical trial and refuse to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jie He, MD,PhD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yousheng Mao, MD

CONTACT

8610-87787138maoysherx@126.com

Zhirong Zhang, MD

CONTACT

8610-87788798zhangzr@cicams.ac.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 20, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

CN(1)