Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247936
Status:
WITHDRAWN
Last Update Posted:
2021-01-26
First Post:
2005-10-31
Brief Title:
Combined Thoracoscopic and Laparoscopic Esophagectomy vs Hand-assisted Transhiatal Esophagectomy A Prospective Trial
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Combined Thoracoscopic and Laparoscopic Esophagectomy vs Hand-assisted Transhiatal Esophagectomy A Prospective Trial
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Prior to recruitment study terminated lack of recruitment interest
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Esophagectomy for benign or malignant disease of the esophagus can be performed using a transhiatal technique or Ivor Lewis technique combined laparotomy with thoracotomy These procedures can be associated with significant morbidity and mortality 1 Advances in minimally invasive technology and surgical techniques have allowed us to explore the possibility of performing esophagectomy using minimally invasive surgical techniques
Minimally invasive esophagectomy represents a new alternative to conventional open esophagectomy It is a technically demanding operation requiring advanced laparoscopic surgical skills appropriate instrumentation and thorough knowledge of open esophagectomy Multiple authors have reported the use of video-assisted thoracoscopy or laparoscopy to facilitate esophagectomy 2-6 Most of these reports have utilized a standard laparotomy in combination with thoracoscopy to perform esophageal mobilization or laparoscopy with a mini-laparotomy to perform esophagectomy DePaula was the first to report a large series of 48 patients undergoing laparoscopic transhiatal esophagectomy for benign n24 and malignant disease n24 7 In 2 patients conversion to open surgery was required and 2 others required thoracoscopic assistance Postoperative complications were low in the benign group but higher in the carcinoma group The 30-day mortality rate was 16 in patients with carcinoma undergoing laparoscopic transhiatal esophagectomy DePaula concluded that the patients who benefit most from this procedure are those with benign disease Swanstrom recently reported nine cases of laparoscopic total esophagectomy 8 There were no conversions to laparotomy One patient required a right thoracoscopy with intrathoracic anastomosis due to poor viability of the gastric tube The mean operative time was 65 hours with a mean hospital stay of 64 days However the advantages of minimally invasive esophagectomy have not been observed The aim of this prospective trial is to evaluate the physiologic outcome clinical outcome and quality of life after combined thoracoscopic and laparoscopic esophagectomy vs transhiatal esophagectomy
Minimally invasive esophagectomy represents a new alternative to conventional open esophagectomy It is a technically demanding operation requiring advanced laparoscopic surgical skills appropriate instrumentation and thorough knowledge of open esophagectomy Multiple authors have reported the use of video-assisted thoracoscopy or laparoscopy to facilitate esophagectomy 2-6 Most of these reports have utilized a standard laparotomy in combination with thoracoscopy to perform esophageal mobilization or laparoscopy with a mini-laparotomy to perform esophagectomy DePaula was the first to report a large series of 48 patients undergoing laparoscopic transhiatal esophagectomy for benign n24 and malignant disease n24 7 In 2 patients conversion to open surgery was required and 2 others required thoracoscopic assistance Postoperative complications were low in the benign group but higher in the carcinoma group The 30-day mortality rate was 16 in patients with carcinoma undergoing laparoscopic transhiatal esophagectomy DePaula concluded that the patients who benefit most from this procedure are those with benign disease Swanstrom recently reported nine cases of laparoscopic total esophagectomy 8 There were no conversions to laparotomy One patient required a right thoracoscopy with intrathoracic anastomosis due to poor viability of the gastric tube The mean operative time was 65 hours with a mean hospital stay of 64 days However the advantages of minimally invasive esophagectomy have not been observed The aim of this prospective trial is to evaluate the physiologic outcome clinical outcome and quality of life after combined thoracoscopic and laparoscopic esophagectomy vs transhiatal esophagectomy
Detailed Description:
RATIONALE
Open esophagectomy can be associated with significant morbidity We hypothesize that laparoscopic esophagectomy is associated with reduced morbidity and a faster recovery
HYPOTHESES
1 Combined thoracoscopic and laparoscopic esophagectomy can be performed safely
2 Combined thoracoscopic and laparoscopic esophagectomy is associated with reduced postoperative pain decrease ICU and hospital stay and reduced postoperative wound morbidity
3 Combined thoracoscopic and laparoscopic esophagectomy is associated with similar long term survival as with the open approach for patients with esophageal malignancies
OBJECTIVES AND SPECIFIC AIMS
1 To compare short-term outcome such as operative time operative and in-patient costs operative complications length of hospital stay and postoperative complications between combined thoracoscopic laparoscopic esophagectomy and transhiatal esophagectomy
2 To evaluate physiologic outcomes after minimally invasive esophagectomy vs transhiatal esophagectomy
3 To determine the long-term outcome disease-free survival survival and quality of life after minimally invasive esophagectomy compared to transhiatal esophagectomy
Open esophagectomy can be associated with significant morbidity We hypothesize that laparoscopic esophagectomy is associated with reduced morbidity and a faster recovery
HYPOTHESES
1 Combined thoracoscopic and laparoscopic esophagectomy can be performed safely
2 Combined thoracoscopic and laparoscopic esophagectomy is associated with reduced postoperative pain decrease ICU and hospital stay and reduced postoperative wound morbidity
3 Combined thoracoscopic and laparoscopic esophagectomy is associated with similar long term survival as with the open approach for patients with esophageal malignancies
OBJECTIVES AND SPECIFIC AIMS
1 To compare short-term outcome such as operative time operative and in-patient costs operative complications length of hospital stay and postoperative complications between combined thoracoscopic laparoscopic esophagectomy and transhiatal esophagectomy
2 To evaluate physiologic outcomes after minimally invasive esophagectomy vs transhiatal esophagectomy
3 To determine the long-term outcome disease-free survival survival and quality of life after minimally invasive esophagectomy compared to transhiatal esophagectomy
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