NCT02355249

Brief Summary

This study is a multi-center, randomized, and open-label trial to compare the safety and feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic esophagectomy for esophageal cancer.

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
648

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2014

Typical duration for phase_3

Geographic Reach
1 country

13 active sites

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

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 4, 2015

Status Verified

January 1, 2015

Enrollment Period

3.3 years

First QC Date

January 26, 2015

Last Update Submit

February 3, 2015

Conditions

Esophageal Carcinoma

Keywords

traditional three incisionsminimally invasive thoracol-laparoscopic esophagectomyMIEesophageal cancer

Outcome Measures

Primary Outcomes (1)

  • The incidence of respiratory complications

    Respiratory complications including respiratory failure requiring mechanical ventilation, atelectasis needs suctioning of bronchoscopy, lung infection needs medication, adult respiratory distress syndrome.

    1 months

Secondary Outcomes (5)

  • Short-term Effects of Traditional Three Incisions Surgery vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer

    2 years

  • The incidence of postoperative complications except respiratory complications

    1 months

  • lung function

    before operation, 1, 3 months after surgery

  • Pain Scores after surgery

    before operation, 1, 3 days and 1, 3, 6 months after surgery

  • Health-related quality of life scores（HRQoL）

    before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery

Other Outcomes (1)

  • blood biomarker analysis

    1 months

Study Arms (2)

A group (MIE)

EXPERIMENTAL

Via minimally invasive thoracol-laparoscopic esophagectomy.

Procedure: MIE

B group (OE)

ACTIVE COMPARATOR

Via traditional three incisions esophagectomy.

Procedure: OE

Interventions

MIEPROCEDURE

Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.

A group (MIE)
OEPROCEDURE

Patients will be treated with traditional three incisions esophagectomy.

B group (OE)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of intrathoracic esophageal carcinoma of Stage I to III, which is potentially resectable judged by MDT
  • ≤age≤75
  • cT1b-4a，N0-2，M0 confirmed by chest CT, EUS, or EUS-FNA in four weeks;
  • ECOG PS scores≤2
  • Laboratory findings in 14 days before operation：normal blood test of basic metabolism panel
  • European Clinical Oncology Group (ECOG) performance status 0,1 or 2
  • More than 12 months of expected survival
  • Tolerance of tracheal intubation and general anesthesia
  • Written informed consent

You may not qualify if:

  • Carcinoma of the cervical esophagus or gastro-esophageal junction (GEJ)
  • Prior thoracic surgery which may effect this study
  • Pregnant or breast feeding
  • Inability to tolerance of tracheal intubation and general anesthesia
  • PS \>2
  • unstable disease
  • Poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Cancer Hospital of Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

China-japan friendship hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 10020, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 630014, China

RECRUITING

Quanzhou First Hospital

Quanzhou, Fujian, 362002, China

RECRUITING

The People's Hospital Of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Nantong Tumor Hospital

Nantong, Jiangsu, 226361, China

RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

The Second People's Hospital of Sichuan

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

  • Mu J, Gao S, Mao Y, Xue Q, Yuan Z, Li N, Su K, Yang K, Lv F, Qiu B, Liu D, Chen K, Li H, Yan T, Han Y, Du M, Xu R, Wen Z, Wang W, Shi M, Xu Q, Xu S, He J. Open three-stage transthoracic oesophagectomy versus minimally invasive thoraco-laparoscopic oesophagectomy for oesophageal cancer: protocol for a multicentre prospective, open and parallel, randomised controlled trial. BMJ Open. 2015 Nov 17;5(11):e008328. doi: 10.1136/bmjopen-2015-008328.

    PMID: 26576807DERIVED

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

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie He, MD

CONTACT

mietrials@126.com;mjwtrials@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. & Ph.D. , President of CICAMS

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 4, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

February 4, 2015

Record last verified: 2015-01

Locations

CN(13)