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Sponsored by: |
University of California, Irvine |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00247936 |
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 (n=24) and malignant disease (n=24) [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 6.5 hours with a mean hospital stay of 6.4 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.
Condition | Intervention |
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Adenocarcinoma |
Procedure: Laparoscopic Esophagectomy |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | Combined Thoracoscopic and Laparoscopic Esophagectomy vs. Hand-Assisted Transhiatal Esophagectomy: A Prospective Trial. |
Estimated Enrollment: | 40 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Combined Thoracoscopic and Laparoscopic Esophagectomy
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Procedure: Laparoscopic Esophagectomy
Laparoscopic Esophagectomy
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2: Active Comparator
Hand-Assisted Transhiatal Esophagectomy
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Procedure: Laparoscopic Esophagectomy
Laparoscopic Esophagectomy
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RATIONALE:
Open esophagectomy can be associated with significant morbidity. We hypothesize that laparoscopic esophagectomy is associated with reduced morbidity and a faster recovery.
HYPOTHESES:
OBJECTIVES AND SPECIFIC AIMS:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Minors and pregnant women are excluded. The chance of esophageal cancer presenting in anyone under 18 years of age is essentially null. Pregnant women are excluded because of safety for the fetus.
United States, California | |
University of California, Irvine, Medical Center | |
Orange, California, United States, 92868 |
Principal Investigator: | Ninh T Nguyen, MD | University of California, Irvine |
Responsible Party: | University of California, Irvine Medical Center ( Ninh T. Nguyen, MD /Chief, Division of Gastrointestinal Surgery ) |
Study ID Numbers: | HS 2003-3422 |
Study First Received: | October 31, 2005 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00247936 History of Changes |
Health Authority: | United States: Institutional Review Board |
Adenocarcinoma, Esophagectomy |
Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |