Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches
Primary Purpose
Esophageal Cancer, Postoperative Complications, Diaphragm
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ivor-Lewis Esophagectomy
Sweet Esophagectomy
Sponsored by
About this trial
This is an interventional prevention trial for Esophageal Cancer focused on measuring esophageal cancer, postoperative complications, diaphragm, pulmonary function
Eligibility Criteria
Inclusion criteria:
- Biopsy or cytology confirmed esophageal carcinoma.
- No-contraindication to surgery.
- Tumor locates at middle or lower thoracic esophagus (e.g. below the level of azygos vein according to AJCC cancer staging manual, esophageal and esophagogastric junctional cancer, 7th edition, 2009), so that the anastomosis could be completed within the thorax
- Informed consent.
Exclusion criteria:
- Patients with low performance status (ECOG score > 1)
- Refuse to participate
- History of adjuvant chemo and/or radiotherapy
- History of malignancy
- Previous abdominal and/or thoracic surgery
- History of pleural disease with obvious pleural adhesion on X-ray examination
- Contraindication to any of the planned intervention procedure
- Pregnancy
- Age of ≥ 70 years
Sites / Locations
- Thoracic Surgery Department, West China Hospital of Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ivor-Lewis
Sweet
Arm Description
Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach
Esophagectomy via Left Side Thoracotomy
Outcomes
Primary Outcome Measures
morbidity of postoperative pulmonary complications
Secondary Outcome Measures
diaphragm movement, pulmonary function, stomach emptying
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01053182
Brief Title
Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches
Official Title
A Phase Ⅲ Study of Respiratory Complications Associated With Esophagectomy Through Either Ivor-Lewis or Sweet Approach for the Treatment of Middle or Lower Third Intrathoracic Esophageal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sichuan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Worldwide, esophageal cancer is the 6th most common cause of cancer-related death. Currently curative resection remains the cornerstone of the therapy. Despite advances in anesthesia, operative techniques and postoperative management, postoperative pulmonary complications (PPCs) occur frequently accounting for about 30% of all postoperative complications. Most importantly, PPCs have much been associated with postoperative mortality. The diaphragm is the most important respiratory muscle and its respiratory function would be inevitably damaged when esophagectomy is performed through the left posterolateral thoracotomy (Sweet procedure) because the diaphragm must be dissected for the purpose of stomach moralization. Meanwhile, Ivor-Lewis approach may effectively avoid diaphragm injury because the stomach can be managed through a laparotomy whereas an additional abdomen incision is needed. Both procedures are routinely used in practice when surgically managing esophageal cancer. The investigators hypothesize that Ivor-Lewis procedure might be superior to the left-thoracotomy route during esophagectomy in preventing PPCs.
Detailed Description
Background:
Esophageal cancer is a common malignant tumor in China and worldwide with poor prognosis. Although the surgical resection combined with adjuvant therapy constitutes the mainstay of the treatment the esophagectomy-associated complications are still life-threatening. Postoperative pulmonary complications (PPCs), including pulmonary infection, atelectasis, edema and ARDS (acute respiratory distress syndrome) are the leading causes of the eventful postoperative episodes.
The diaphragm is the well known essential respiratory muscle whose normal function guarantees more than 30% of pulmonary function. Esophagectomy through left thoracotomy would inevitably cut off the left diaphragm for the abdominal procedure and thus greatly damage the diaphragmatic function. It has been assumed that Ivor-Lewis esophagectomy would save the pulmonary function to a great extent by retaining the intact diaphragm but the addition of a laparotomy would be unavoidable. However, this hypothesis has not been confirmed by any randomized controlled trial with adequate operation volume. At present, a large part of thoracic surgeons, for example in China, still prefer esophagectomy through Sweet approach believing that it is less traumatic. So far, there is presently no convincing evidence to guide the esophagectomy approach selection on the aspect of prevention of PPCs.
Objectives:
To compare the PPCs rates after Ivor-Lewis esophagectomy and Sweet esophagectomy
To compare the degrees of diaphragm function deficiencies between two groups.
To compare the pulmonary function results between two groups
To compare the degrees of gastric emptying between two groups
Diagnostic Criteria for PPCs: any one of the followings and not because of anastomotic leak, massive pleural effusion and non-pulmonary origin infection:
postoperative hypoxemia (PaO2≤ 60mmHg and/or PaCO2≥ 50mmHg) or dyspnea
transfer to intensive care unit due to hypoxemia or dyspnea
purulent pulmonary secretions requiring bronchoscopic suction
dependence on oxygen mask or nasal tube for more than 5 days
infiltrating or atelectasis in one pulmonary lobe or multiple segments identified by chest X-ray film or CT scan)
postoperative hiatal hernia associated pulmonary dysfunction
dependence on ventilator support for more than 48h
Degree of diaphragm function: The distance of diaphragmatic movement in centimeters
Pulmonary function measurement: FEV1, FVC and MMV
Gastric emptying function: Radioactivity remained at 15 minutes after ingestion of 100ml Tm99-labelled radioactive milk
Design:
Prospective randomized controlled trial.
Setting:
Thoracic Surgery Department, West China Hospital of Sichuan University, Chengdu, China
Patients and methods:
All patients with histologically confirmed esophageal carcinoma located at the middle or lower thoracic esophagus presenting to our hospital will be considered for the study
Termination criteria:
Intolerance of any of the treatment modality,
Development of PPCs
Development of any other severe complication, such as progressive bleeding, large pleural effusion, empyema
Death
Staging investigations will be standard and will include
Computed Tomography (CT) of Chest in all patients
Fibroesophagoscopy in all patients
Esophagogram by barium swallow in all patients
Endoscopic Ultrasonography (EUS) wherever possible Further investigation likes bronchoscopy, PET scan, or MRI will be applied if indicated.
Randomization:
Complete randomization will be done using a computer generated sheet. Randomization will be performed after confirming resectability of the primary tumor and enlarged lymph nodes.
All surgeries will be performed under general anesthesia with epidural analgesia. The surgery will be performed either by Dr. Longqi Chen or Dr. Yidan Lin who is the faculty and professor of the thoracic surgery department of West China Hospital. Thoracic esophageal mobilization and mediastinal lymphadenectomy will be done by open thoracotomy. Stomach dissection and gastric tube making will be done either through the left diaphragm incision when left thoracotomy is applied or through the laparotomy when Ivor-Lewis approach is applied. 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. Patients will be started on oral feeds between the 8th and 10th day in the absence of an anastomotic leak. The total duration of ICU stay and hospital stay will also be recorded.
Sample size:
The sample size considering an improvement of morbidity of sever pulmonary complications from 15% to 5% will be 280 patients (140 in each arm). The trial will aim at enrolling 320 patients in order to adjust for protocol violations. Interim analyses will be done when ½ (160 events) of the estimated events occur. We expect to complete accrual of patients in three years.
Follow up:
No follow up after discharge. The long-term pulmonary function is not the concern of this clinical trail.
Data management:
All collected data will be entered into a statistical software package for subsequent analysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Postoperative Complications, Diaphragm, Pulmonary Function
Keywords
esophageal cancer, postoperative complications, diaphragm, pulmonary function
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ivor-Lewis
Arm Type
Active Comparator
Arm Description
Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach
Arm Title
Sweet
Arm Type
Active Comparator
Arm Description
Esophagectomy via Left Side Thoracotomy
Intervention Type
Procedure
Intervention Name(s)
Ivor-Lewis Esophagectomy
Other Intervention Name(s)
Right sided esophagectomy
Intervention Description
Esophagectomy via Right Side Thoracotomy Plus Midline Laparotomy Approach
Intervention Type
Procedure
Intervention Name(s)
Sweet Esophagectomy
Other Intervention Name(s)
Left sided esophagectomy
Intervention Description
Esophagectomy through Left Side Thoracotomy
Primary Outcome Measure Information:
Title
morbidity of postoperative pulmonary complications
Time Frame
within 10 postoperative days
Secondary Outcome Measure Information:
Title
diaphragm movement, pulmonary function, stomach emptying
Time Frame
within 10 postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Biopsy or cytology confirmed esophageal carcinoma.
No-contraindication to surgery.
Tumor locates at middle or lower thoracic esophagus (e.g. below the level of azygos vein according to AJCC cancer staging manual, esophageal and esophagogastric junctional cancer, 7th edition, 2009), so that the anastomosis could be completed within the thorax
Informed consent.
Exclusion criteria:
Patients with low performance status (ECOG score > 1)
Refuse to participate
History of adjuvant chemo and/or radiotherapy
History of malignancy
Previous abdominal and/or thoracic surgery
History of pleural disease with obvious pleural adhesion on X-ray examination
Contraindication to any of the planned intervention procedure
Pregnancy
Age of ≥ 70 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Longqi Chen, MD, PhD
Phone
+86 138 8203 0466
Email
wchrct001@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yidan Lin, MD, PhD
Phone
+86 189 80602136
Email
yidan.lin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Longqi Chen, MD, PhD
Organizational Affiliation
West China Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Thoracic Surgery Department, West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Longqi Chen, MD, PhD
Phone
+86 138 8203 0466
Email
wchrct001@gmail.com
First Name & Middle Initial & Last Name & Degree
Yidan Lin, MD, PhD
Phone
+86 189 80602136
Email
yidan.lin@gmail.com
First Name & Middle Initial & Last Name & Degree
Longqi Chen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yidan Lin, MD, PhD
12. IPD Sharing Statement
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Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches
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