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

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: Unknown
• Conditions: Esophageal Carcinoma
• Intervention / Treatment: Procedure: MIE; Procedure: OE

• Study Type: Interventional
• Enrollment (Anticipated): 648
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jie He, MD; Email: mietrials@126.com;mjwtrials@126.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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	1 months
lung function	lung function will be measured by VC,FVC,FEV1,DLCO	before operation, 1, 3 months after surgery
Pain Scores 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）	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

Outcome Measure	Measure Description	Time Frame
blood biomarker analysis	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

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: 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

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: esophageal cancer; traditional three incisions; minimally invasive thoracol-laparoscopic esophagectomy; MIE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 201412