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Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches

NCT01053182 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2010-01-21

No results posted yet for this study

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

Interventions

PROCEDURE

Ivor-Lewis Esophagectomy

Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach

PROCEDURE

Sweet Esophagectomy

Esophagectomy through Left Side Thoracotomy

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Principal Investigators

  • Longqi Chen, MD, PhD · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053182 on ClinicalTrials.gov