CompletedNot Applicable

Esophagectomy: Sweet Versus Ivor-Lewis (ESVIL) (ECTOP-2001)

China300 participantsStarted 2010-05

Plain-language summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-2001. Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection remains the basic method of management of this malignancy. Although different approaches have been described for the surgical resection of esophageal cancer, there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal surgical approach for esophageal cancer. The purpose of this study is to test two different approach of transthoracic esophagectomy (Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure and Left Side Thoracotomy Approach: Sweet Procedure) in middle or lower third intrathoracic esophageal cancer. This research is being done to see whether one approach is superior than the other approach with better long-term outcome and acceptable postoperative short-term outcome or not.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with histologically proven squamous cell esophageal cancer * Patients with cT1-T3/N0-N1 mid or distal third (inferior to carina and 3cm superior to cardia ) operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, barium swallow and selective endoscopic ultrasonography showing no evidence of invading adjacent structure such as spine, bronchus, pericardium , descending aorta and without enlargement cervical and celiac nodes (diameter of short axis greater than 1.5cm) measured at CT scans. * Karnofsky performance status greater than or equal to 80% * Pulmonary and cardiac function must be acceptable for surgery according to institutional standards. * Acceptable hepatic, renal and bone marrow function Exclusion Criteria: * Patients with low performance status(Karnofsky score \<80%) * Past history of malignancy * Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b) * Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment * Patients medically unfit for surgical resection * Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy. * Patients with a significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment. * Uncontrolled diabetes mell…

What they're measuring

Disease free survival

Timeframe: 6 years

Trial details

NCT IDNCT01047111

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07