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Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches

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ClinicalTrials.gov Identifier: NCT01053182
Recruitment Status : Unknown
Verified December 2009 by Sichuan University.
Recruitment status was:  Recruiting
First Posted : January 21, 2010
Last Update Posted : January 21, 2010
Sponsor:
Information provided by:
Sichuan University

Brief Summary:
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 or disease Intervention/treatment Phase
Esophageal Cancer Postoperative Complications Diaphragm Pulmonary Function Procedure: Ivor-Lewis Esophagectomy Procedure: Sweet Esophagectomy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
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
Study Start Date : January 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: West China Hospital / Longqi Chen, Professor, Sichuan University
ClinicalTrials.gov Identifier: NCT01053182     History of Changes
Other Study ID Numbers: WCH-RCT-001
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: January 21, 2010
Last Verified: December 2009

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

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