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

February 3, 2015 updated by: Jie He, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
648

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital
        • Contact:
          • Keneng Chen, MD
        • Principal Investigator:
          • Keneng Chen, MD
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Tiansheng Yan, MD
        • Principal Investigator:
          • Tiansheng Yan, MD
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Deruo Liu, MD
        • Principal Investigator:
          • Deruo Liu, MD
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital of Chinese Academy of Medical Science
        • Contact:
          • Jie He, MD
        • Principal Investigator:
          • Jie He, MD
        • Sub-Investigator:
          • Juwei Mou, MD
      • Beijing, Beijing, China, 10020
        • Recruiting
        • Beijing Chao-Yang Hospital
        • Principal Investigator:
          • Hui Li, MD
    • Chongqing
      • Chongqing, Chongqing, China, 630014
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Ming Du, MD
        • Principal Investigator:
          • Ming Du
    • Fujian
      • Quanzhou, Fujian, China, 362002
        • Recruiting
        • Quanzhou First Hospital
        • Contact:
          • Rongyu Xu
        • Principal Investigator:
          • Rongyu Xu
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
          • Zhaoke Wen
        • Principal Investigator:
          • Zhaoke Wen
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Jianping Liang, MD
        • Principal Investigator:
          • Jianping Liang, MD
    • Jiangsu
      • Nantong, Jiangsu, China, 226361
        • Recruiting
        • Nantong Tumor Hospital
        • Contact:
          • Minxin Shi
        • Principal Investigator:
          • Minxin Shi
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
          • Quan Xu
        • Principal Investigator:
          • Quan Xu
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Shun Xu
        • Principal Investigator:
          • Shun Xu
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • The Second People's Hospital of Sichuan
        • Contact:
          • Yongtao Han
        • Principal Investigator:
          • Yongtao Han

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologic diagnosis of intrathoracic esophageal carcinoma of Stage I to III, which is potentially resectable judged by MDT
  2. 18≤age≤75
  3. cT1b-4a，N0-2，M0 confirmed by chest CT, EUS, or EUS-FNA in four weeks;
  4. ECOG PS scores≤2
  5. Laboratory findings in 14 days before operation：normal blood test of basic metabolism panel
  6. European Clinical Oncology Group (ECOG) performance status 0,1 or 2
  7. More than 12 months of expected survival
  8. Tolerance of tracheal intubation and general anesthesia
  9. Written informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A group (MIE)
Via minimally invasive thoracol-laparoscopic esophagectomy.
Procedure: MIE
Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.
Active Comparator: B group (OE)
Via traditional three incisions esophagectomy.
Procedure: OE
Patients will be treated with traditional three incisions esophagectomy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of respiratory complications
Time Frame: 1 months
Respiratory complications including respiratory failure requiring mechanical ventilation, atelectasis needs suctioning of bronchoscopy, lung infection needs medication, adult respiratory distress syndrome.
1 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short-term Effects of Traditional Three Incisions Surgery vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer
Time Frame: 2 years
To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, 2 years DFS) between two groups.
2 years
The incidence of postoperative complications except respiratory complications
Time Frame: 1 months
Surgical Complications except respiratory complications(such as infection, esophageal fistula, etc.) will be measured by the Clavien-Dindo Classification
1 months
lung function
Time Frame: before operation, 1, 3 months after surgery
lung function will be measured by VC,FVC,FEV1,DLCO
before operation, 1, 3 months after surgery
Pain Scores after surgery
Time Frame: before operation, 1, 3 days and 1, 3, 6 months after surgery
Pain Scores will be measured by Brief pain inventory(BPI)
before operation, 1, 3 days and 1, 3, 6 months after surgery
Health-related quality of life scores（HRQoL）
Time Frame: before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery
HRQoL will be measured by EORTC QLO-C30, QLQ-OES18
before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
blood biomarker analysis
Time Frame: 1 months
The presence of inflammatory factors and stress response indicators (ATCH, C- reactive protein, interleukin-6, etc.)of esophageal tissue specimens and blood samples will be explored
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University Third Hospital
Hunan Cancer Hospital
Peking University Cancer Hospital & Institute
Beijing Chao Yang Hospital
China-Japan Friendship Hospital
First Hospital of China Medical University
First Affiliated Hospital of Chongqing Medical University
Quanzhou First Hospital
People's Hospital of Guangxi
The Second People's Hospital of Sichuan
Jiangxi Provincial People's Hopital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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