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Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Sichuan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sichuan University
ClinicalTrials.gov Identifier:
NCT01053182
First received: January 20, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

Worldwide, esophageal cancer is the 6th most common cause of cancer-related death. Currently curative resection remains the cornerstone of the therapy. Despite advances in anesthesia, operative techniques and postoperative management, postoperative pulmonary complications (PPCs) occur frequently accounting for about 30% of all postoperative complications. Most importantly, PPCs have much been associated with postoperative mortality. The diaphragm is the most important respiratory muscle and its respiratory function would be inevitably damaged when esophagectomy is performed through the left posterolateral thoracotomy (Sweet procedure) because the diaphragm must be dissected for the purpose of stomach moralization. Meanwhile, Ivor-Lewis approach may effectively avoid diaphragm injury because the stomach can be managed through a laparotomy whereas an additional abdomen incision is needed. Both procedures are routinely used in practice when surgically managing esophageal cancer. The investigators hypothesize that Ivor-Lewis procedure might be superior to the left-thoracotomy route during esophagectomy in preventing PPCs.


Condition Intervention Phase
Esophageal Cancer
Postoperative Complications
Diaphragm
Pulmonary Function
 Procedure: Ivor-Lewis Esophagectomy
Procedure: Sweet Esophagectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase Ⅲ Study of Respiratory Complications Associated With Esophagectomy Through Either Ivor-Lewis or Sweet Approach for the Treatment of Middle or Lower Third Intrathoracic Esophageal Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sichuan University:

Primary Outcome Measures:
  • morbidity of postoperative pulmonary complications [ Time Frame: within 10 postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diaphragm movement, pulmonary function, stomach emptying [ Time Frame: within 10 postoperative days ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ivor-Lewis
Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach
 Procedure: Ivor-Lewis Esophagectomy
Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach
Other Name: Right sided esophagectomy
Active Comparator: Sweet
Esophagectomy via Left Side Thoracotomy
 Procedure: Sweet Esophagectomy
Esophagectomy through Left Side Thoracotomy
Other Name: Left sided esophagectomy

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  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Biopsy or cytology confirmed esophageal carcinoma.
  2. No-contraindication to surgery.
  3. Tumor locates at middle or lower thoracic esophagus (e.g. below the level of azygos vein according to AJCC cancer staging manual, esophageal and esophagogastric junctional cancer, 7th edition, 2009), so that the anastomosis could be completed within the thorax
  4. Informed consent.

Exclusion criteria:

  1. Patients with low performance status (ECOG score > 1)
  2. Refuse to participate
  3. History of adjuvant chemo and/or radiotherapy
  4. History of malignancy
  5. Previous abdominal and/or thoracic surgery
  6. History of pleural disease with obvious pleural adhesion on X-ray examination
  7. Contraindication to any of the planned intervention procedure
  8. Pregnancy
  9. Age of ≥ 70 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053182

Contacts
Contact: Longqi Chen, MD, PhD +86 138 8203 0466 wchrct001@gmail.com
Contact: Yidan Lin, MD, PhD +86 189 80602136 yidan.lin@gmail.com

Locations
China, Sichuan
Thoracic Surgery Department, West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610042
Contact: Longqi Chen, MD, PhD     +86 138 8203 0466     wchrct001@gmail.com    
Contact: Yidan Lin, MD, PhD     +86 189 80602136     yidan.lin@gmail.com    
Principal Investigator: Longqi Chen, MD, PhD            
Sub-Investigator: Yidan Lin, MD, PhD            
Sponsors and Collaborators
Sichuan University
Investigators
Study Director: Longqi Chen, MD, PhD West China Hospital
  More Information

No publications provided

Responsible Party: West China Hospital / Longqi Chen, Professor, Sichuan University
ClinicalTrials.gov Identifier: NCT01053182     History of Changes
Other Study ID Numbers: WCH-RCT-001
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: China: Ministry of Health

Keywords provided by Sichuan University:
esophageal cancer
postoperative complications
diaphragm
pulmonary function

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

ClinicalTrials.gov processed this record on May 23, 2013