Ignite Creation Date:
2024-05-05 @ 10:12 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01053182
Status:
UNKNOWN
Last Update Posted:
2010-01-21
First Post:
2010-01-20
Brief Title:
Esophagectomy Associated Respiratory Complications Ivor-Lewis Versus Sweet Approaches
Sponsor:
Sichuan University
Organization:
Sichuan University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 To compare the PPCs rates after Ivor-Lewis esophagectomy and Sweet esophagectomy
2 To compare the degrees of diaphragm function deficiencies between two groups
3 To compare the pulmonary function results between two groups
4 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
1 postoperative hypoxemia PaO2 60mmHg andor PaCO2 50mmHg or dyspnea
2 transfer to intensive care unit due to hypoxemia or dyspnea
3 purulent pulmonary secretions requiring bronchoscopic suction
4 dependence on oxygen mask or nasal tube for more than 5 days
5 infiltrating or atelectasis in one pulmonary lobe or multiple segments identified by chest X-ray film or CT scan
6 postoperative hiatal hernia associated pulmonary dysfunction
7 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
1 Intolerance of any of the treatment modality
2 Development of PPCs
3 Development of any other severe complication such as progressive bleeding large pleural effusion empyema
4 Death
Staging investigations will be standard and will include
1 Computed Tomography CT of Chest in all patients
2 Fibroesophagoscopy in all patients
3 Esophagogram by barium swallow in all patients
4 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
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
1 To compare the PPCs rates after Ivor-Lewis esophagectomy and Sweet esophagectomy
2 To compare the degrees of diaphragm function deficiencies between two groups
3 To compare the pulmonary function results between two groups
4 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
1 postoperative hypoxemia PaO2 60mmHg andor PaCO2 50mmHg or dyspnea
2 transfer to intensive care unit due to hypoxemia or dyspnea
3 purulent pulmonary secretions requiring bronchoscopic suction
4 dependence on oxygen mask or nasal tube for more than 5 days
5 infiltrating or atelectasis in one pulmonary lobe or multiple segments identified by chest X-ray film or CT scan
6 postoperative hiatal hernia associated pulmonary dysfunction
7 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
1 Intolerance of any of the treatment modality
2 Development of PPCs
3 Development of any other severe complication such as progressive bleeding large pleural effusion empyema
4 Death
Staging investigations will be standard and will include
1 Computed Tomography CT of Chest in all patients
2 Fibroesophagoscopy in all patients
3 Esophagogram by barium swallow in all patients
4 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None