Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches

NCT01053182 | Unknown Phase 3 DMC

• 1 other identifier: WCH-RCT-001
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Postoperative Complications; Diaphragm; Pulmonary Function

Keywords

esophageal cancer; postoperative complications; diaphragm; pulmonary function

Outcome Measures

Primary Outcomes (1)

• morbidity of postoperative pulmonary complications

  within 10 postoperative days

Secondary Outcomes (1)

• diaphragm movement, pulmonary function, stomach emptying

  within 10 postoperative days

Study Arms (2)

Ivor-Lewis

ACTIVE COMPARATOR

Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach

Procedure: Ivor-Lewis Esophagectomy

Sweet

ACTIVE COMPARATOR

Esophagectomy via Left Side Thoracotomy

Procedure: Sweet Esophagectomy

Interventions

Ivor-Lewis Esophagectomy PROCEDURE

Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach

Also known as: Right sided esophagectomy

Ivor-Lewis

Sweet Esophagectomy PROCEDURE

Esophagectomy through Left Side Thoracotomy

Also known as: Left sided esophagectomy

Sweet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy or cytology confirmed esophageal carcinoma.
• No-contraindication to surgery.
• 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
• Informed consent.

You may not qualify if:

• Patients with low performance status (ECOG score \> 1)
• Refuse to participate
• History of adjuvant chemo and/or radiotherapy
• History of malignancy
• Previous abdominal and/or thoracic surgery
• History of pleural disease with obvious pleural adhesion on X-ray examination
• Contraindication to any of the planned intervention procedure
• Pregnancy
• Age of ≥ 70 years

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

Thoracic Surgery Department, West China Hospital of Sichuan University

Chengdu, Sichuan, 610042, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Longqi Chen, MD, PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Longqi Chen, MD, PhD

CONTACT

+86 138 8203 0466; wchrct001@gmail.com

Yidan Lin, MD, PhD

CONTACT

+86 189 80602136; yidan.lin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 21, 2010

Record last verified: 2009-12

Locations

CN (1)