Esophagectomy:Three-field Versus Two-field Lymphadenectomy (ECTOP-2002)
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-2002. Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical
      resection with radical lymphadenectomy remains the basic method of management of this
      malignancy. Lymph node metastasis is one of the most important factors in predicting the
      prognosis of patients with esophageal carcinoma, but the extent of lymph node dissection is
      still in debate, and there is no statistical evidence based on large scale prospective
      randomized trials with regard to the issue that which is the optimal extent of
      lymphadenectomy for esophageal cancer. The purpose of this study is to test two different
      extents of lymphadenectomy (Cervical-thoracic-upper abdominal three-field lymphadenectomy and
      Thoracic-upper abdominal two -field lymphadenectomy) in middle or lower third intrathoracic
      esophageal cancer. This research is being done to see whether one extent of lymphadenectomy
      is superior than the other 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 with
      radical lymphadenectomy remains the basic method of management of this malignancy. The
      international Society for Diseases of the Esophagus has classified the extent of
      lymphadenectomy as standard, extended, total, and three-field lymphadenectomy. However, lymph
      node metastases can be present as regional metastasis, skip metastasis and distant
      metastasis, the optimal extent of lymphadenectomy remains controversial by now. Three-filed
      lymphadenectomy was criticized for higher surgical risks, but have the merits of removing all
      potential positive nodes and reducing the local recurrence. 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 extent of lymphadenectomy is superior than the
      other approach or not.

      Objectives:

        1. To compare overall survival after three-field lymphadenectomy and two-field
           lymphadenectomy

        2. To compare locoregional recurrence, disease free survival after three-field
           lymphadenectomy and two-field lymphadenectomy

        3. To compare postoperative morbidity and mortality in the two groups

      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:

      Randomization, by the sealed envelope method, took place on the morning of planed surgery
      day.

      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: Overall survival

      Secondary endpoints:

        1. Disease free survival in the two arms

        2. Locoregional recurrence

        3. Postoperative morbidity and mortality
    

Intervention name(s): Lymphadenectomy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal Neoplasms; lymphadenectomy