Combined Thoracoscopic and Laparoscopic Esophagectomy vs. Hand-assisted Transhiatal Esophagectomy: A Prospective Trial.
18 Years
N/A
Both
Adenocarcinoma
Trial Information
Combined Thoracoscopic and Laparoscopic Esophagectomy vs. Hand-assisted Transhiatal Esophagectomy: A Prospective Trial.
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
short-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy
Outcome Time Frame:
30-day
Safety Issue:
No
Principal Investigator
Ninh T Nguyen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Irvine
Authority:
United States: Institutional Review Board
Study ID:
HS 2003-3422
NCT ID:
NCT00247936
Start Date:
May 2004
Completion Date:
April 2010
Related Keywords:
- Adenocarcinoma
- Adenocarcinoma, Esophagectomy
- Adenocarcinoma
- Adenocarcinoma, Mucinous
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