Mediastinoscopy-assisted Transhiatal Esophagectomy Versus Thoraco-laparoscopic Esophagectomy for Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title:

Mediastinoscopy-assisted Transhiatal Esophagectomy (MATHE) Versus Thoraco-laparoscopic Esophagectomy (TLE) for Esophageal Cancer: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04125849
• Other study ID #: NCC201819B69
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: December 2022

Study information

• Verified date: April 2020
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Juwei Mu, MD
• Phone: 8610-87788495
• Email: mujuwei[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Esophageal cancer is one of the major diseases that seriously threatens an individual's health and life. To reduce the incidence of postoperative complications and mortality of esophageal cancer, thoraco-laparoscopic oesophagectomy (TLE) has been recommended by many guidelines since the 2000s. Additionally, with developments in endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practice. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centres in China. However, there is no multicentre prospective randomized controlled study that explored the safety, feasibility and short-term clinical efficacy between mediastinoscopy-assisted transhiatal esophagectomy and thoraco-laparoscopic esophagectomy. We aim to evaluate the feasibility and safety of MATHE.

Description:

Esophageal resection remains the mainstay of treatment for esophageal cancer patients. Despite improvements in surgical technique and perioperative management, esophagectomy carries considerable operative risk. To reduce the incidence of postoperative complications and mortality of esophageal cancer, the optional of minimally invasive esophagectomy has been recommended by many guidelines since 2000s. In addition, with the development of endoscopy technology in recent years, mediastinoscopy-assisted transhiatal esophagectomy (MATHE) has been used in clinical practices. In 2015, the first mediastinoscopy combined with laparoscopic radical esophagectomy was reported systematically by Hitoshi Fujiwara. This surgical procedure has been performed in many centers of China since then. Compared with MIE, MATHE allows controlled dissection of upper mediastinum and biopsy of mediastinal lymph nodes. No study directly comparing MATHE versus MIE has been reported to date. In this report, we compare MATHE with MIE in terms of surgical feasibility, safety, and survival.We intend to adopt a randomized controlled study method. The study group is mediastinoscopy-assisted transhiatal esophagectomy (MATHE) group, and the control group is thoraco-laparoscopic esophagectomy (TLE) group. This study is expected to provide high-level evidence for the new methods and to provide better treatment options for patients with esophageal cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 years=age= 80 years;

• Histologically diagnosed with squamous cell carcinoma by endoscopic biopsy, cT1-3N0M0;

• Primary tumour is located in the thoracic oesophagus

• No clinical evidence of distant organ metastasis

• No severe comorbidity, can tolerate anesthesia;

• ECOG PS scores=2;

• The patients sign informed consents by themselves.

Exclusion Criteria:

• Cervical or abdominal oesophageal carcinoma;

• Previous oesophagectomy, gastrectomy, or mediastinal surgery;

• Current uncontrolled illness such as severe cardiac disease, uncontrollable hypertension or diabetes, or active bacterial infection;

• Unable to tolerate tracheal intubation and general anaesthesia as determined by an anaesthesiologist preoperatively;

• Pregnant or lactating women;

• ECOG PS scores>2;

• Considered unsuitable, such as those who do not agree to participate in the trial.

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Procedure:
• Thoraco-laparoscopic esophagectomy
Thoraco-laparoscopic esophagectomy surgery
• Mediastinoscopy-assisted transhiatal esophagectomy
Mediastinoscopy-assisted transhiatal esophagectomy surgery

Locations

Country	Name	City	State
China	Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Center	Shenzhen	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing Cancer Hospital, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Hubei Cancer Hospital, Quanzhou First Hospital, The First Affiliated Hospital of Anhui Medical University, The People's Hospital of Gaozhou, The Second People's Hospital of Huai'an

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative respiratory complications	These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.	30 days after surgery
Secondary	pulmonary function indicators	pulmonary function indicators	30 days after surgery
Secondary	anastomotic fistula	anastomotic fistula	30 days after surgery
Secondary	recurrent laryngeal nerve palsy	recurrent laryngeal nerve palsy	recurrent laryngeal nerve palsy
Secondary	DFS	Disease-free survival,DFS	3 years
Secondary	duration of surgery	Total operation time	Intraoperation
Secondary	Blood loss	blood loss during the surgery	Intraoperation
Secondary	Conversion rate	conversion to thoracotomy during surgery	Intraoperation
Secondary	postoperative hospital stay	postoperative hospital stay	postoperation
Secondary	postoperative pain score	postoperative pain score	postoperation
Secondary	drainage time	drainage time	postoperation
Secondary	R0 resection rate	R0 resection rate	Intraoperation
Secondary	Lymph node dissection	During the surgery, lymph node dissection were performed. The number of removed lymph-nodes were recorded according to the postoperative pathological diagnosis, and the stations of the lymph node were recorded.	Intraoperation
Secondary	Local recurrence	three-year local tumour recurrence or distant metastasis rate after surgery	3 years
Secondary	30-day mortality after surgery	30-day mortality after surgery	postoperation