Full Text View
Tabular View
No Study Results Posted
Related Studies
Combined Thoracoscopic and Laparoscopic Esophagectomy vs. Hand-Assisted Transhiatal Esophagectomy: A Prospective Trial.
This study is ongoing, but not recruiting participants.
First Received: October 31, 2005   Last Updated: March 21, 2008   History of Changes
Sponsored by: University of California, Irvine
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00247936
  Purpose

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
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.

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • short-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy [ Time Frame: 30-day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • long-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy. [ Time Frame: 5 year ] [ Designated as safety issue: No ]

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
1: Active Comparator
Combined Thoracoscopic and Laparoscopic Esophagectomy
Procedure: Laparoscopic Esophagectomy
Laparoscopic Esophagectomy
2: Active Comparator
Hand-Assisted Transhiatal Esophagectomy
Procedure: Laparoscopic Esophagectomy
Laparoscopic 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with biopsy proven esophageal malignancies
  2. Patients with recalcitrant severe esophageal stricture
  3. Karnofsky score >60
  4. No previous treatment for any other cancer over the past 2 years (except for skin cancer)

Exclusion Criteria:

  1. Malignant tracheoesophageal fistula or presence of tracheal involvement
  2. Unacceptable operative risk
  3. Tumor size greater than 12 centimeters.
  4. Tumor involvement of the aorta or trachea.
  5. Renal or liver insufficiency (Creatinine > 2.0, transaminase > fourfold)
  6. WBCs <2,000, platelets <80,000
  7. Presence of metastatic disease
  8. Patients with previous esophageal resection
  9. 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.

    • All physician, hospital, surgery, and laboratory costs will be billed to the subject and/or their insurance carrier as customary for they are considered standard of care procedures. All research-related procedures such as pulmonary function tests and study questionnaires conducted in this study will be paid for by the primary investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247936

Locations
United States, California
University of California, Irvine, Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Ninh T Nguyen, MD University of California, Irvine
  More Information

No publications provided

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

Keywords provided by University of California, Irvine:
Adenocarcinoma, Esophagectomy

Study placed in the following topic categories:
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 10, 2009