Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063986
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2003-07-08
Brief Title:
Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I Stage II or Stage III Esophageal Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Minimally Invasive Esophagectomy MIE A Multicenter Feasibility Study
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
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:
RATIONALE Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery
PURPOSE This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I stage II or stage III esophageal cancer
PURPOSE This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I stage II or stage III esophageal cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of performing minimally invasive esophagectomy MIE in terms of 30-day mortality in patients with high-grade dysplasia of the esophagus or stage I-III esophageal cancer
Determine the complications associated with this procedure in these patients
Determine the rate at which conversion to open operation is required in patients undergoing this procedure
Determine the length of the operation duration of intensive care unit stay and length of hospital stay in patients undergoing this procedure
Determine feasibility and conversion rate of MIE after neoadjuvant therapy
Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected
Assess outcomes at follow-up to three years
OUTLINE This is a multicenter study
Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus Mortality at 30 days is assessed
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
ACTUAL ACCRUAL A total of 110 patients were accrued for this study
Determine the feasibility of performing minimally invasive esophagectomy MIE in terms of 30-day mortality in patients with high-grade dysplasia of the esophagus or stage I-III esophageal cancer
Determine the complications associated with this procedure in these patients
Determine the rate at which conversion to open operation is required in patients undergoing this procedure
Determine the length of the operation duration of intensive care unit stay and length of hospital stay in patients undergoing this procedure
Determine feasibility and conversion rate of MIE after neoadjuvant therapy
Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected
Assess outcomes at follow-up to three years
OUTLINE This is a multicenter study
Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus Mortality at 30 days is assessed
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
ACTUAL ACCRUAL A total of 110 patients were accrued for this study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E2202 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |