Trial Information

A Phase Ⅲ Study of Left Side Thoracotomy Approach (Sweet Procedure) Versus Right Side Thoracotomy Plus Midline Laparotomy Approach (Ivor-Lewis Procedure) Esophagectomy in Middle or Lower Third Intrathoracic Esophageal Cancer

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.