Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-05 @ 12:49 AM
Study NCT ID:
NCT02448966
Status:
UNKNOWN
Last Update Posted:
2015-05-20
First Post:
2015-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic and Laparoscopic Esophagectomy
Sponsor:
Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic/Laparoscopic Esophagectomy for cT1b-3N0-1M0 Thoracic Esophageal Cancer
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: