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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

Phase 3
18 Years
70 Years
Open (Enrolling)
Esophageal Neoplasms

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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


1. To compare overall survival after right side approach and left side approach

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


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.

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

- 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

- Patients considered of salvage surgery after definitive chemoradiotherapy

- Patients after neoadjuvant chemoradiotherapy

- Patients above the age of 75 years

- Patients unreliable for follow up

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

Jan 2010-Jan 2016

Safety Issue:


Principal Investigator

Haiquan Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

July 2016

Related Keywords:

  • Esophageal Neoplasms
  • Esophageal Neoplasms
  • Esophagectomy
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms