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Esophageal CarcinomaPhase 3NCT02355249

Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer

A Phase 3 study testing MIE and OE in people with Esophageal Carcinoma, run by Chinese Academy of Medical Sciences at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Carcinoma
What is being tested?
MIE and OE
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
648 participants
Where
13 sitesChina
Study dates
Sep 2014to Jan 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic diagnosis of intrathoracic esophageal carcinoma of Stage I to III, which is potentially resectable judged by MDT
  • 18≤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
Show all 9Show fewer
  • More than 12 months of expected survival
  • Tolerance of tracheal intubation and general anesthesia
  • Written informed consent

Who cannot join

  • 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

Trial locations and contacts

13 sites in 1 country.

Jie He, MD contact

mietrials@126.com;mjwtrials@126.com

13 sites in 1 country

China13 sites, 13 recruiting

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

    Jie He, MD

    Jie He, MD

    Recruiting

  • China-japan friendship hospital

    Beijing, Beijing Municipality, 100029

    Deruo Liu, MD

    Deruo Liu, MD

    Recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Keneng Chen, MD

    Keneng Chen, MD

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Tiansheng Yan, MD

    Tiansheng Yan, MD

    Recruiting

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality, 10020

    Hui Li, MD

    Hui Li, MD

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Jianping Liang, MD

    Jianping Liang, MD

    Recruiting

  • The Second People's Hospital of Sichuan

    Chengdu, Sichuan, 610041

    Yongtao Han

    Yongtao Han

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014

    Ming Du, MD

    Ming Du

    Recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

    Quan Xu

    Quan Xu

    Recruiting

  • The People's Hospital Of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

    Zhaoke Wen

    Zhaoke Wen

    Recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361

    Minxin Shi

    Minxin Shi

    Recruiting

  • Quanzhou First Hospital

    Quanzhou, Fujian, 362002

    Rongyu Xu

    Rongyu Xu

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Shun Xu

    Shun Xu

    Recruiting

Other trials in China

About this study

Official title: Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer: a Multi-center, Randomized, and Open-label Trial

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.

Being tested
MIE, OE
Keywords
traditional three incisions, minimally invasive thoracol-laparoscopic esophagectomy, MIE, esophageal cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIEProcedure or surgery

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

  • OEProcedure or surgery

    Patients will be treated with traditional three incisions esophagectomy.

Study groups in NCT02355249
Study groupRoleWhat they receive
A group (MIE)ExperimentalVia minimally invasive thoracol-laparoscopic esophagectomy.
Receives: Procedure: MIE
B group (OE)Active comparatorVia traditional three incisions esophagectomy.
Receives: Procedure: OE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 months

Secondary outcomes (5)

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

    To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, 2 years DFS) between two groups.

    Measured: 2 years

  2. The incidence of postoperative complications except respiratory complications

    Surgical Complications except respiratory complications(such as infection, esophageal fistula, etc.) will be measured by the Clavien-Dindo Classification

    Measured: 1 months

  3. lung function

    lung function will be measured by VC,FVC,FEV1,DLCO

    Measured: before operation, 1, 3 months after surgery

  4. Pain Scores after surgery

    Pain Scores will be measured by Brief pain inventory(BPI)

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

  5. Health-related quality of life scores（HRQoL）

    HRQoL will be measured by EORTC QLO-C30, QLQ-OES18

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionDec 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
648 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02355249
Sponsor's protocol ID
201412
Status last verified
Jan 2015
First submitted
26 Jan 2015
Last updated
4 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26576807

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MIE and OE in people with Esophageal Carcinoma, run by Chinese Academy of Medical Sciences at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jie He, MD (mietrials@126.com;mjwtrials@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of respiratory complications (time frame: 1 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02355249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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