Clinical trial NCT02355249: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Carcinoma
Keywords: traditional three incisions
minimally invasive thoracol-laparoscopic esophagectomy
MIE
esophageal cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: China-Japan Friendship Hospital
name: Peking University Cancer Hospital & Institute
name: Beijing Chao Yang Hospital
name: Peking University Third Hospital
name: The Second People's Hospital of Sichuan
name: First Affiliated Hospital of Chongqing Medical University
name: Hunan Cancer Hospital
name: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
name: First Hospital of China Medical University
name: Quanzhou First Hospital
name: Jiangxi Provincial People's Hopital
name: People's Hospital of Guangxi Zhuang Autonomous Region
First posted: 2015-02-04
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The incidence of respiratory complications
timeFrame: 1 months
Secondary outcomes:
measure: Short-term Effects of Traditional Three Incisions Surgery vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer
timeFrame: 2 years
measure: The incidence of postoperative complications except respiratory complications
timeFrame: 1 months
measure: lung function
timeFrame: before operation, 1, 3 months after surgery
measure: Pain Scores after surgery
timeFrame: before operation, 1, 3 days and 1, 3, 6 months after surgery
measure: Health-related quality of life scores（HRQoL）
timeFrame: before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery
Other outcomes:
measure: blood biomarker analysis
timeFrame: 1 months
Locations:
city: Beijing
country: China
facility: Cancer Hospital of Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: China-japan friendship hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Quanzhou
country: China
facility: Quanzhou First Hospital
state: Fujian
city: Nanning
country: China
facility: The People's Hospital Of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Chengdu
country: China
facility: The Second People's Hospital of Sichuan
state: Sichuan
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jie He, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.