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

January 22, 2021 updated by: University of California, Irvine

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Combined Thoracoscopic and Laparoscopic Esophagectomy
Procedure: Laparoscopic Esophagectomy
Laparoscopic Esophagectomy
Other Names:
  • Laparoscopic Esophagectomy; Hand-Assisted Transhiatal Esophagectomy
Active Comparator: 2
Hand-Assisted Transhiatal Esophagectomy
Procedure: Laparoscopic Esophagectomy
Laparoscopic Esophagectomy
Other Names:
  • Laparoscopic Esophagectomy; Hand-Assisted Transhiatal Esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
short-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy
Time Frame: 30-day
30-day

Secondary Outcome Measures

Outcome Measure
Time Frame
long-term surgical outcome of minimally invasive esophagectomy vs. transhiatal esophagectomy.
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS 2003-3422

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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