Clinical trial NCT04125849: Mediastinoscopy-assisted Transhiatal Esophagectomy Versus Thoraco-laparoscopic Esophagectomy for Esophageal Cancer
Official title: Mediastinoscopy-assisted Transhiatal Esophagectomy (MATHE) Versus Thoraco-laparoscopic Esophagectomy (TLE) for Esophageal Cancer: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Neoplasms
Keywords: Mediastinoscopy-assisted transhiatal esophagectomy (MATHE)
Thoraco-laparoscopic esophagectomy (TLE)
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
name: Peking University Cancer Hospital & Institute
name: Hubei Cancer Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Quanzhou First Hospital
name: The People's Hospital of Gaozhou
name: The Second People's Hospital of Huai'an
First posted: 2019-10-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative respiratory complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: pulmonary function indicators
timeFrame: 30 days after surgery
measure: anastomotic fistula
timeFrame: 30 days after surgery
measure: recurrent laryngeal nerve palsy
timeFrame: recurrent laryngeal nerve palsy
measure: DFS
timeFrame: 3 years
measure: duration of surgery
timeFrame: Intraoperation
measure: Blood loss
timeFrame: Intraoperation
measure: Conversion rate
timeFrame: Intraoperation
measure: postoperative hospital stay
timeFrame: postoperation
measure: postoperative pain score
timeFrame: postoperation
measure: drainage time
timeFrame: postoperation
measure: R0 resection rate
timeFrame: Intraoperation
measure: Lymph node dissection
timeFrame: Intraoperation
measure: Local recurrence
timeFrame: 3 years
measure: 30-day mortality after surgery
timeFrame: postoperation
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Center
state: Guangdong
Study officials:
affiliation: National Cancer Center of China
name: Juwei Mu, MD
role: PRINCIPAL_INVESTIGATOR
References: