Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic and Laparoscopic Esophagectomy

• Conditions: Esophageal Cancer
• Interventions: Procedure: Minimally invasive esophagectomy; Procedure: open esophagectomy

• Registration Number: NCT02448966
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-05
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-19
• Last Update Submitted: 2015-05-19
• Study First Posted: 2015-05-20
• Last Update Posted: 2015-05-20
• Primary Completion: 2017-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimally invasive eophagectomy	Minimally invasive esophagectomy	treated by minimally invasive thorascopic/laparoscopic esophagectomy in the centers with enough experience in VATS esophagectomy and the volume≧50 cases each year.
Traditional open esophagectomy	open esophagectomy	Treated by traditional three-incision esophagectomy in the centers with enough experience in esophagectomy via right thoracotomy and the volume ≧50 cases each year.

Primary Outcome Measures

Name	Time	Method
Long term survival	5 years

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	3 years
Disease free survival	5 years

Trial Locations

Locations (1)

Cancer hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China