We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Esophagectomy: Sweet Versus Ivor-Lewis (ESVIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01047111
Recruitment Status : Unknown
Verified July 2012 by Fudan University.
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2010
Last Update Posted : February 27, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection remains the basic method of management of this malignancy. Although different approaches have been described for the surgical resection of esophageal cancer, there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal surgical approach for esophageal cancer. The purpose of this study is to test two different approach of transthoracic esophagectomy (Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure and Left Side Thoracotomy Approach: Sweet Procedure) in middle or lower third intrathoracic esophageal cancer. This research is being done to see whether one approach is superior than the other approach with better long-term outcome and acceptable postoperative short-term outcome or not.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Procedure: Esophagectomy Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅲ Study of Left Side Thoracotomy Approach (Sweet Procedure) Versus Right Side Thoracotomy Plus Midline Laparotomy Approach (Ivor-Lewis Procedure) Esophagectomy in Middle or Lower Third Intrathoracic Esophageal Cancer
Study Start Date : May 2010
Primary Completion Date : July 2012
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Ivor-Lewis Procedure
Arm A: Esophagectomy was conducted through right side thoracotomy plus midline laparotomy approach:Ivor-Lewis Procedure.
Procedure: Esophagectomy
Esophagectomy Through Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure VS Esophagectomy Through Left Side Thoracotomy Approach: Sweet Procedure
Other Names:
  • Right side approach esophagectomy
  • Left side approach esophagectomy
Active Comparator: Sweet Procedure
Arm B: Esophagectomy was conducted through left side thoracotomy or thoracoabdominal incision: Sweet Procedure
Procedure: Esophagectomy
Esophagectomy Through Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure VS Esophagectomy Through Left Side Thoracotomy Approach: Sweet Procedure
Other Names:
  • Right side approach esophagectomy
  • Left side approach esophagectomy


Outcome Measures

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: Jan 2010-Jan 2016 ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Jan 2010-Jan 2016 ]
  2. postoperative morbidity and mortality [ Time Frame: Jan 2010-Jan 2016 ]
  3. Locoreginal recurrence and recurrence pattern [ Time Frame: Jan 2010-Jan 2016 ]
  4. quality of life [ Time Frame: Jan 2010-Jan 2016 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically proven squamous cell esophageal cancer
  • Patients with cT1-T3/N0-N1 mid or distal third (inferior to carina and 3cm superior to cardia ) operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, barium swallow and selective endoscopic ultrasonography showing no evidence of invading adjacent structure such as spine, bronchus, pericardium , descending aorta and without enlargement cervical and celiac nodes (diameter of short axis greater than 1.5cm) measured at CT scans.
  • Karnofsky performance status greater than or equal to 80%
  • Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
  • Acceptable hepatic, renal and bone marrow function

Exclusion Criteria:

  • Patients with low performance status(Karnofsky score <80%)
  • Past history of malignancy
  • Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b)
  • Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
  • Patients medically unfit for surgical resection
  • Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
  • Patients with a significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment.
  • Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
  • Significant psychiatric illness that would interfere with patient compliance
  • Patients with severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
  • Patients considered of salvage surgery after definitive chemoradiotherapy
  • Patients after neoadjuvant chemoradiotherapy
  • Patients above the age of 75 years
  • Patients unreliable for follow up
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047111


Locations
China, Shanghai
Fudan University Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Haiquan Chen, MD Fudan University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haiquan Chen MD, Fudan University Cancer Center
ClinicalTrials.gov Identifier: NCT01047111     History of Changes
Other Study ID Numbers: 201001ECFD
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: July 2012

Keywords provided by Fudan University:
Esophageal Neoplasms
Esophagectomy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases