Esophageal Cancer
Conditions
Brief summary
Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection remains the most effective method for this malignant disease. VATS esophagectomy has become more and more popular in China and around the world. Although VATS esophagectomy has been proven to be effective in preventing respiratory complications, there is still no ample evidences to demonstrate that VATS esophagectomy is as effective as traditional three-incision esophagectomy in lymph node dissection and is equal or superior in long-term survival. The purpose of this large scale prospective observational study is to compare the minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision esophagectomy in lymph node dissection, postoperative recovery, postoperative complications, and long-term survival.
Detailed description
Esophageal carcinoma is an aggressive malignancy with poor prognosis,For these patients, radical esophagectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor. However, the percentage of cardiopulmonary complications associated with the traditional three-incision esophagectomy is high.Recent studies have shown that the minimally invasive thorascopic and laparoscopic esophagectomy is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes,including reduced blood loss, shorter ICU stay,and lower pulmonary complication rate, but the evidence is not ample because the sample size is not enough.The objective of this study is to compare the efficacy, perioperative complications, lymph node dissection and long term survival between the thoracic esophageal cancer patients treated by minimally invasive thorascopic/laparoscopic esophagectomy and open transthoracic esophagectomy by three incisions.
Interventions
PROCEDUREopen esophagectomy
PROCEDUREMinimally invasive esophagectomy
Sponsors
Peking University Cancer Hospital & Institute
Henan Cancer Hospital
Hebei Medical University Fourth Hospital
Shanghai Zhongshan Hospital
Harbin Medical University
Sichuan Cancer Hospital and Research Institute
Fujian Cancer Hospital
Liaoning Cancer Hospital & Institute
Hunan Cancer Hospital
Sun Yat-sen University
Zhejiang Cancer Hospital
Tang-Du Hospital
Shanghai Chest Hospital
Chinese Academy of Medical Sciences
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically proven squamous cell esophageal cancer, without any previous anti-tumor therapy; 2. Preoperative clinical TNM stage:cT1b-3N0-1M0; 3. Adequate cardiopulmonary, liver, brain and kidney function which can tolerate the esophagectomy either via traditional tree-incision or minimally invasive thorascopic/laparoscopic esophagectomy; 4. Preoperative assessment by CT and EUS is fit for minimally invasive thorascopic/laparoscopic esophagectomy; 5. Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail.
Exclusion criteria
1. Previous use of anti-cancer therapy; 2. Preoperative clinical TNM stage: N2-3 or M1; 3. Inadequate cardiopulmonary,liver, brain and kidney function for surgery; 4. Previous malignancy history; 5. Unwilling to participate the clinical trial and refuse to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long term survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival | 5 years |
| Postoperative complications | 3 years |
Countries
China
Contacts
Primary ContactYousheng Mao, MD
Backup ContactZhirong Zhang, MD
Outcome results
None listed