Combined Thoracoscopic and Laparoscopic Esophagectomy vs. Hand-assisted Transhiatal Esophagectomy: A Prospective Trial.

NCT00247936 | Withdrawn

• 1 other identifier: HS 2003-3422
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Adenocarcinoma

Keywords

Adenocarcinoma, Esophagectomy

Outcome Measures

Primary Outcomes (1)

• short-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy

  30-day

Secondary Outcomes (1)

• long-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy.

  5 year

Study Arms (2)

1

ACTIVE COMPARATOR

Combined Thoracoscopic and Laparoscopic Esophagectomy

Procedure: Laparoscopic Esophagectomy

2

ACTIVE COMPARATOR

Hand-Assisted Transhiatal Esophagectomy

Procedure: Laparoscopic Esophagectomy

Interventions

Laparoscopic Esophagectomy PROCEDURE

Laparoscopic Esophagectomy

Also known as: Laparoscopic Esophagectomy; Hand-Assisted Transhiatal Esophagectomy

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ninh T Nguyen, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 2, 2005
• Study Start: May 1, 2004
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: January 26, 2021

Record last verified: 2021-01