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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.