Esophagectomy: Sweet Versus Ivor-Lewis (ESVIL) (ECTOP-2001)
Condition: Esophageal Neoplasms
MeSH terms: Esophageal Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      Background :

      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. In middle or lower third
      intrathoracic esophageal cancer, a great number of thoracic surgeon preferred the Ivor-Lewis
      Procedure(Right Side Thoracotomy plus Midline Laparotomy Approach), and believe that this
      approach can get better exposure for the upper mediastinal node dissection so can get the
      better long-term survival. But some others preferred the Sweet Procedure(Left Side
      Thoracotomy Approach),especially in china, more than two of the third unit performed the left
      side approach esophagectomy routinely and the long-term survival was reported equal to even
      better than the right side approach. The purpose of this study is to conduct a large scale
      prospective randomized Phase Ⅲ clinical trial to test that based on the long-term
      outcomes(overall survival and disease free survival )and postoperative short-term
      outcomes(mortality, morbidity),whether one approach is superior than the other approach or
      not.

      Objectives:

        1. To compare overall survival after right side approach and left side approach
           esophagectomy

        2. To compare locoregional recurrence, disease free survival after right side approach and
           left side approach esophagectomy

        3. To compare postoperative morbidity and mortality in the two groups

        4. To evaluate short and long term quality of life after the two procedures

      Design: Prospective randomized controlled

      Setting: Fudan University Cancer Center, Shanghai, China.

      Patients and methods : All patients with biopsy proven carcinoma of the middle or lower third
      of the esophagus presenting to our hospital will be considered for the study.

      Staging investigations will be standard and will include

        1. Computed Tomography (CT) scans in all patients

        2. Esophagogastroscopy

        3. Barium swallow

        4. Endoscopic Ultrasonography (EUS) wherever possible

        5. PET-CT scan wherever possible

      Randomization:

      Block randomization will be done using a computer generated sheet. Randomization will be
      performed 3 days to 1 week before the operation.

      All surgeries will be performed under general anesthesia with epidural analgesia. The surgery
      will be either performed by or under the direct supervision of consultant thoracic surgeons
      with experience in esophageal surgery. Operative time, blood loss, blood product replacement
      and all intraoperative details will be recorded in the proforma. Patients will be shifted
      postoperatively to the intensive care unit (ICU) for observation and subsequently to the
      recovery or high dependency ward once stabilized. Postoperative details including period of
      postoperative ventilation, hemorrhage, pulmonary and cardiac complications, arrhythmias,
      thoracic duct leak, anastomotic leak, wound infection and recurrent laryngeal nerve paresis
      or palsy will be recorded. Postoperative mortality will be defined as 30-day mortality plus
      death before discharge after surgery. The total duration of ICU stay and hospital stay will
      also be recorded.

      Follow up:

      Patients will be followed up three monthly for the first two years and six monthly for the
      third to fifth years and annually thereafter. A detailed history and clinical examination and
      CT scan, barium swallow and ultrasound will be done routinely on every follow up.

      Data management: All collected data will be entered into a statistical software package for
      subsequent analysis

      Main research variables:

      Primary end point: Disease free survival in the two arms

      Secondary endpoints:

        1. Overall survival

        2. Locoregional recurrence

        3. Postoperative morbidity and mortality

        4. Quality of life : assessed with EORTC QLQ-C30 scale and EORTC QLQ- OES18 scale.
    

Intervention name(s): Esophagectomy
Intervention type(s): Procedure
Intervention description(s): Esophagectomy Through Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure VS Esophagectomy Through Left Side Thoracotomy Approach: Sweet Procedure
Other intervention name(s): Right side approach esophagectomy; Left side approach esophagectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal Neoplasms; Esophagectomy