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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04125849
Other study ID # NCC201819B69
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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