This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Sichuan University.
Recruitment status was:  Recruiting
Information provided by:
Sichuan University Identifier:
First received: January 20, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
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
Intervention Model: Parallel Assignment
Masking: None (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:

Further study details as provided by Sichuan University:

Primary Outcome Measures:
  • morbidity of postoperative pulmonary complications [ Time Frame: within 10 postoperative days ]

Secondary Outcome Measures:
  • diaphragm movement, pulmonary function, stomach emptying [ Time Frame: within 10 postoperative days ]

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

  Show Detailed Description


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01053182

Contact: Longqi Chen, MD, PhD +86 138 8203 0466
Contact: Yidan Lin, MD, PhD +86 189 80602136

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   
Contact: Yidan Lin, MD, PhD    +86 189 80602136   
Principal Investigator: Longqi Chen, MD, PhD         
Sub-Investigator: Yidan Lin, MD, PhD         
Sponsors and Collaborators
Sichuan University
Study Director: Longqi Chen, MD, PhD West China Hospital
  More Information

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

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

Additional relevant MeSH terms:
Esophageal Neoplasms
Postoperative Complications
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes processed this record on August 18, 2017