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

NCT01047111 | Completed

• 1 other identifier: 201001ECFD
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Neoplasms

Keywords

Esophageal Neoplasms; Esophagectomy

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  6 years

Secondary Outcomes (3)

• Overall survival

  6 years

• postoperative morbidity and mortality

  3 years

• Locoreginal recurrence and recurrence pattern

  6 years

Study Arms (2)

Ivor-Lewis Procedure

ACTIVE COMPARATOR

Arm A: Esophagectomy was conducted through right side thoracotomy plus midline laparotomy approach:Ivor-Lewis Procedure.

Procedure: Esophagectomy

Sweet Procedure

ACTIVE COMPARATOR

Arm B: Esophagectomy was conducted through left side thoracotomy or thoracoabdominal incision: Sweet Procedure

Procedure: Esophagectomy

Interventions

Esophagectomy PROCEDURE

Esophagectomy Through Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure VS Esophagectomy Through Left Side Thoracotomy Approach: Sweet Procedure

Also known as: Right side approach esophagectomy, Left side approach esophagectomy

Ivor-Lewis Procedure; Sweet Procedure

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
• Significant psychiatric illness that would interfere with patient compliance
• Patients with severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
• Patients considered of salvage surgery after definitive chemoradiotherapy
• Patients after neoadjuvant chemoradiotherapy
• Patients above the age of 75 years
• Patients unreliable for follow up

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Li B, Xiang J, Zhang Y, Li H, Zhang J, Sun Y, Hu H, Miao L, Ma L, Luo X, Chen S, Ye T, Zhang Y, Zhang Y, Chen H. Comparison of Ivor-Lewis vs Sweet esophagectomy for esophageal squamous cell carcinoma: a randomized clinical trial. JAMA Surg. 2015 Apr;150(4):292-8. doi: 10.1001/jamasurg.2014.2877.

  PMID: 25650816 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Haiquan Chen, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of thoracic surgery

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2017
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)