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

Primary Purpose

Esophageal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MIE
OE
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Carcinoma focused on measuring traditional three incisions, minimally invasive thoracol-laparoscopic esophagectomy, MIE, esophageal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Hospital of Chinese Academy of Medical ScienceRecruiting
  • China-japan friendship hospitalRecruiting
  • Peking University Cancer HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Beijing Chao-Yang HospitalRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • Quanzhou First HospitalRecruiting
  • The People's Hospital Of Guangxi Zhuang Autonomous RegionRecruiting
  • Hunan Cancer HospitalRecruiting
  • Nantong Tumor HospitalRecruiting
  • Jiangxi Provincial People's HospitalRecruiting
  • The First Hospital of China Medical UniversityRecruiting
  • The Second People's Hospital of SichuanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A group (MIE)

B group (OE)

Arm Description

Via minimally invasive thoracol-laparoscopic esophagectomy.

Via traditional three incisions esophagectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
lung function
lung function will be measured by VC,FVC,FEV1,DLCO
Pain Scores after surgery
Pain Scores will be measured by Brief pain inventory(BPI)
Health-related quality of life scores（HRQoL）
HRQoL will be measured by EORTC QLO-C30, QLQ-OES18

Full Information

First Posted
January 26, 2015
Last Updated
February 3, 2015
Sponsor
Chinese Academy of Medical Sciences
Collaborators
China-Japan Friendship Hospital, Peking University Cancer Hospital & Institute, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02355249
Brief Title
Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer
Official Title
Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer: a Multi-center, Randomized, and Open-label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
China-Japan Friendship Hospital, Peking University Cancer Hospital & Institute, 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma
Keywords
traditional three incisions, minimally invasive thoracol-laparoscopic esophagectomy, MIE, esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
648 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group (MIE)
Arm Type
Experimental
Arm Description
Via minimally invasive thoracol-laparoscopic esophagectomy.
Arm Title
B group (OE)
Arm Type
Active Comparator
Arm Description
Via traditional three incisions esophagectomy.
Intervention Type
Procedure
Intervention Name(s)
MIE
Intervention Description
Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.
Intervention Type
Procedure
Intervention Name(s)
OE
Intervention Description
Patients will be treated with traditional three incisions esophagectomy.
Primary Outcome Measure Information:
Title
The incidence of respiratory complications
Description
Respiratory complications including respiratory failure requiring mechanical ventilation, atelectasis needs suctioning of bronchoscopy, lung infection needs medication, adult respiratory distress syndrome.
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Short-term Effects of Traditional Three Incisions Surgery vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer
Description
To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, 2 years DFS) between two groups.
Time Frame
2 years
Title
The incidence of postoperative complications except respiratory complications
Description
Surgical Complications except respiratory complications(such as infection, esophageal fistula, etc.) will be measured by the Clavien-Dindo Classification
Time Frame
1 months
Title
lung function
Description
lung function will be measured by VC,FVC,FEV1,DLCO
Time Frame
before operation, 1, 3 months after surgery
Title
Pain Scores after surgery
Description
Pain Scores will be measured by Brief pain inventory(BPI)
Time Frame
before operation, 1, 3 days and 1, 3, 6 months after surgery
Title
Health-related quality of life scores（HRQoL）
Description
HRQoL will be measured by EORTC QLO-C30, QLQ-OES18
Time Frame
before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery
Other Pre-specified Outcome Measures:
Title
blood biomarker analysis
Description
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
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 More than 12 months of expected survival Tolerance of tracheal intubation and general anesthesia Written informed consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie He, MD
Email
mietrials@126.com;mjwtrials@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie He, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie He, MD
First Name & Middle Initial & Last Name & Degree
Jie He, MD
First Name & Middle Initial & Last Name & Degree
Juwei Mou, MD
Facility Name
China-japan friendship hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deruo Liu, MD
First Name & Middle Initial & Last Name & Degree
Deruo Liu, MD
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keneng Chen, MD
First Name & Middle Initial & Last Name & Degree
Keneng Chen, MD
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiansheng Yan, MD
First Name & Middle Initial & Last Name & Degree
Tiansheng Yan, MD
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Li, MD
First Name & Middle Initial & Last Name & Degree
Hui Li, MD
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
630014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Du, MD
First Name & Middle Initial & Last Name & Degree
Ming Du
Facility Name
Quanzhou First Hospital
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongyu Xu
First Name & Middle Initial & Last Name & Degree
Rongyu Xu
Facility Name
The People's Hospital Of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaoke Wen
First Name & Middle Initial & Last Name & Degree
Zhaoke Wen
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Liang, MD
First Name & Middle Initial & Last Name & Degree
Jianping Liang, MD
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226361
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minxin Shi
First Name & Middle Initial & Last Name & Degree
Minxin Shi
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Xu
First Name & Middle Initial & Last Name & Degree
Quan Xu
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shun Xu
First Name & Middle Initial & Last Name & Degree
Shun Xu
Facility Name
The Second People's Hospital of Sichuan
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongtao Han
First Name & Middle Initial & Last Name & Degree
Yongtao Han

12. IPD Sharing Statement

Citations:
PubMed Identifier
26576807
Citation
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.
Results Reference
derived

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

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