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

Esophageal Cancer Clinical Trial

Official title:

Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic/Laparoscopic Esophagectomy for cT1b-3N0-1M0 Thoracic Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448966
• Other study ID #: NKTRDP-2015BAI12B08-02
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2015
• Last updated: May 19, 2015
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: May 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Yousheng Mao, MD
• Phone: 8610-87787138
• Email: maoysherx[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• open esophagectomy

• Minimally invasive esophagectomy

Locations

Country	Name	City	State
China	Cancer hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (14)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Beijing Cancer Hospital, Fujian Cancer Hospital, Harbin Medical University, Hebei Medical University Fourth Hospital, Henan Cancer Hospital, Hunan Cancer Hospital, Liaoning Tumor Hospital & Institute, Shanghai Chest Hospital, Shanghai Zhongshan Hospital, Sichuan Cancer Hospital and Research Institute, Sun Yat-sen University, Tang-Du Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term survival		5 years	Yes
Secondary	Disease free survival		5 years	Yes
Secondary	Postoperative complications		3 years	Yes