Status:
WITHDRAWN
Combined Thoracoscopic and Laparoscopic Esophagectomy vs. Hand-assisted Transhiatal Esophagectomy: A Prospective Trial.
Lead Sponsor:
University of California, Irvine
Conditions:
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 as...
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....
Eligibility Criteria
Inclusion
- Patients with biopsy proven esophageal malignancies
- Patients with recalcitrant severe esophageal stricture
- Karnofsky score \>60
- No previous treatment for any other cancer over the past 2 years (except for skin cancer)
Exclusion
- Malignant tracheoesophageal fistula or presence of tracheal involvement
- Unacceptable operative risk
- Tumor size greater than 12 centimeters.
- Tumor involvement of the aorta or trachea.
- Renal or liver insufficiency (Creatinine \> 2.0, transaminase \> fourfold)
- WBCs \<2,000, platelets \<80,000
- Presence of metastatic disease
- Patients with previous esophageal resection
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00247936
Start Date
May 1 2004
End Date
May 1 2004
Last Update
January 26 2021
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