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

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ClinicalTrials.gov Identifier: NCT02355249
Recruitment Status : Unknown
Verified January 2015 by Jie He, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : February 4, 2015
Last Update Posted : February 4, 2015
Sponsor:
Collaborators:
China-Japan Friendship Hospital
Beijing Cancer Hospital
Beijing Chao Yang Hospital
Peking University Third Hospital
The Second People's Hospital of Sichuan
First Affiliated Hospital of Chongqing Medical University
Hunan Cancer Hospital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
First Hospital of China Medical University
Quanzhou First Hospital
Jiangxi Provincial People's Hopital
People's Hospital of Guangxi
Information provided by (Responsible Party):
Jie He, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Esophageal Carcinoma Procedure: MIE Procedure: OE Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer: a Multi-center, Randomized, and Open-label Trial
Study Start Date : September 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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

  3. lung function [ Time Frame: before operation, 1, 3 months after surgery ]
    lung function will be measured by VC,FVC,FEV1,DLCO

  4. 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)

  5. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355249


Contacts
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Contact: Jie He, MD mietrials@126.com;mjwtrials@126.com

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jie He, M.D. & Ph.D. , President of CICAMS, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02355249     History of Changes
Other Study ID Numbers: 201412
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: January 2015
Keywords provided by Jie He, Chinese Academy of Medical Sciences:
traditional three incisions
minimally invasive thoracol-laparoscopic esophagectomy
MIE
esophageal cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Surgical Wound
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Wounds and Injuries
Menthol
Antipruritics
Dermatologic Agents