An interventional study of Laparoscopic Esophagectomy in Adenocarcinoma, sponsored by University of California, Irvine. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
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:
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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.
Combined Thoracoscopic and Laparoscopic Esophagectomy
Procedure: Laparoscopic Esophagectomy
Hand-Assisted Transhiatal Esophagectomy
Procedure: Laparoscopic Esophagectomy
Laparoscopic Esophagectomy
Also known as: Laparoscopic Esophagectomy; Hand-Assisted Transhiatal Esophagectomy
short-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy
Time frame: 30-day
long-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy.
Time frame: 5 year
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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University of California, Irvine