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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02448966

Collaborator

Peking University Cancer Hospital & Institute (Other), Henan Cancer Hospital (Other), Hebei Medical University Fourth Hospital (Other), Shanghai Zhongshan Hospital (Other), Harbin Medical University (Other), Sichuan Cancer Hospital and Research Institute (Other), Fujian Cancer Hospital (Other), Liaoning Tumor Hospital & Institute (Other), Hunan Cancer Hospital (Other), Sun Yat-sen University (Other), Zhejiang Cancer Hospital (Other), Tang-Du Hospital (Other), Shanghai Chest Hospital (Other)

1,000

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Procedure: open esophagectomy Procedure: Minimally invasive esophagectomy

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Traditional 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.	Procedure: open esophagectomy
Minimally invasive eophagectomy treated by minimally invasive thorascopic/laparoscopic esophagectomy in the centers with enough experience in VATS esophagectomy and the volume≧50 cases each year.	Procedure: Minimally invasive esophagectomy

Arm

Intervention/Treatment

Traditional 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.

Procedure: open esophagectomy

Minimally invasive eophagectomy

treated by minimally invasive thorascopic/laparoscopic esophagectomy in the centers with enough experience in VATS esophagectomy and the volume≧50 cases each year.

Procedure: Minimally invasive esophagectomy

Outcome Measures

Primary Outcome Measures

Long term survival [5 years]

Secondary Outcome Measures

Disease free survival [5 years]
Postoperative complications [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with histologically proven squamous cell esophageal cancer, without any previous anti-tumor therapy;
Preoperative clinical TNM stage:cT1b-3N0-1M0;
Adequate cardiopulmonary, liver, brain and kidney function which can tolerate the esophagectomy either via traditional tree-incision or minimally invasive thorascopic/laparoscopic esophagectomy;
Preoperative assessment by CT and EUS is fit for minimally invasive thorascopic/laparoscopic esophagectomy;
Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail.

Exclusion Criteria:

Previous use of anti-cancer therapy;
Preoperative clinical TNM stage: N2-3 or M1;
Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
Previous malignancy history;
Unwilling to participate the clinical trial and refuse to sign informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer hospital, Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021

Investigators

Principal Investigator: Jie He, MD,PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jie He, President, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02448966

Other Study ID Numbers:

NKTRDP-2015BAI12B08-02

First Posted:

May 20, 2015

Last Update Posted: