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

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

cT1b-3N0-1M0 thoracic esophageal cancer.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long term survival	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease free survival	5 years
Postoperative complications	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (ESTIMATE): May 20, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: NKTRDP-2015BAI12B08-02