Esophagectomy: Sweet Versus Ivor-Lewis
Summary
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.
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.
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 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
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Esophageal Neoplasms
Intervention
Esophagectomy
Location
Fudan University Cancer Center
Shanghai
Shanghai
China
200032
Status
Not yet recruiting
Source
Fudan University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01047111
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Esophageal Neoplasms
Tumors or cancer of the ESOPHAGUS.
Diverticulosis, Esophageal
A pathological condition characterized by the presence of a number of ESOPHAGEAL DIVERTICULA in the ESOPHAGUS.
Esophagectomy
Excision of part (partial) or all (total) of the esophagus. (Dorland, 28th ed)
Neoplasms By Site
A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.
Esophageal Motility Disorders
Disorders affecting the motor function of the UPPER ESOPHAGEAL SPHINCTER; LOWER ESOPHAGEAL SPHINCTER; the ESOPHAGUS body, or a combination of these parts. The failure of the sphincters to maintain a tonic pressure may result in gastric reflux of food and acid into the esophagus (GASTROESOPHAGEAL REFLUX). Other disorders include hypermotility (spastic disorders) and markedly increased amplitude in contraction (nutcracker esophagus).
Clinical Trials
A multicenter randomized comparison of primary esophagectomy against definitive chemoradiotherapy for the treatment of squamous esophageal cancer.
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
The purpose of this study is to test 2 different methods of surgery to remove cancer in the esophagus. This research is being done to see whether removing more tissue and lymph nodes sur...
We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.
Minimally Invasive Esophagectomy (MIE) in Prone Versus Left Decubitus Position
The purpose of this prospective randomized study is to compare clinical outcomes from two different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization in t...
PubMed Articles
Mediastinoscopy-assisted esophagectomy for esophageal cancer in patients with serious comorbidities.
PURPOSE: We evaluated the results of mediastinoscopy-assisted esophagectomy (MAE), performed for esophageal cancer patients with comorbidities, versus those of thoracoscopic esop...
Thoracoscopic and Laparoscopic Esophagectomy with Cervical Manual Anastomosis for Esophageal Cancer.
Evidence on the benefits of minimally invasive approach over traditional open procedure in gastrointestinal surgery is continuing to accumulate. This is also the case for esophageal surgery.Although l...
Modifications to Ivor Lewis esophagectomy.
The surgical approach to esophagectomy is variable. A number of factors are considered when determining the optimal approach to esophagectomy: location and extent of disease, fibrosis, additional pati...
BACKGROUND: Anastomosis performed during esophagectomy for esophageal cancer is usually involves hand-sewn or circular stapled methods. However, these techniques have been reported to be associated wi...
A 73-year-old male patient was admitted to our hospital due to bilateral leg edema and proteinuria in April 2009. After admission, nephrotic syndrome (membranous nephropathy) was diagnosed. At that po...
