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

Esophageal Carcinoma Clinical Trial

Official title:

Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer: a Multi-center, Randomized, and Open-label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02355249
• Other study ID #: 201412
• Status: Recruiting
• Phase: Phase 3
• First received: January 26, 2015
• Last updated: February 3, 2015
• Start date: September 2014
• Est. completion date: January 2018

Study information

• Verified date: January 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Jie He, MD
• Email: mietrials[@]126.com;mjwtrials[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 648
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Procedure:
• MIE
Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.
• OE
Patients will be treated with traditional three incisions esophagectomy.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing	Beijing
China	Cancer Hospital of Chinese Academy of Medical Science	Beijing	Beijing
China	China-japan friendship hospital	Beijing	Beijing
China	Peking University Cancer Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Second People's Hospital of Sichuan	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The People's Hospital Of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Quanzhou First Hospital	Quanzhou	Fujian
China	The First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (13)

Lead Sponsor

Collaborator

Chinese Academy of Medical Sciences

Beijing Cancer Hospital, Beijing Chao Yang Hospital, China-Japan Friendship Hospital, First Affiliated Hospital of Chongqing Medical University, First Hospital of China Medical University, Hunan Cancer Hospital, Jiangxi Provincial People's Hopital, Peking University Third Hospital, People's Hospital of Guangxi, Quanzhou First Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, The Second People's Hospital of Sichuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	lung function	lung function will be measured by VC,FVC,FEV1,DLCO	before operation, 1, 3 months after surgery	Yes
Secondary	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	Yes
Secondary	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	No