Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512265
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2007-08-06
Brief Title:
Influence of N-Acetylcysteine on Morbidity Oxygenation and Cytokine Levels in Partial or Total Esophagectomy for Cancer
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Influence of N-Acetylcysteine on Morbidity Oxygenation and Cytokine Levels in Partial or Total Esophagectomy for Cancer A Multicenter Prospective Randomised Double Blind Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
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:
The purpose of this study is to evaluate the effect of high-dose n-acetylcysteine on inflammatory reaction pulmonary morbidity oxygenation and quality of life in patients undergoing transthoracic partial or total resection of the esophagus for cancer
Detailed Description:
Cancer of the esophagus has a poor long term prognosis as well as high perioperative morbidity Pulmonary complications play thereby a major role The standard procedure is either a combined transabdominaltransthoracic approach which allows better visualisation of the tumor and more radical surgery which may increase R0 resections and consequently overall survival or a blunt transhiatal technique In Zurich Basel and Lucerne the combined technique is the standard procedure The combined surgical approach pre-existing pulmonary disorders poor nutritional status and the release of pro-inflammatory cytokines may be important contributing factors to pulmonary complications such as pneumonia atelectasis pleural effusions and the Acute Respiratory Distress Syndrome ARDS N-Acetylcysteine NAC has been shown to have direct and indirect oxygen scavenging abilities In severe sepsis and acute respiratory distress syndrome positive effects of NAC on morbidity and mortality were discovered Aim of this study is to assess the influence of NAC on morbidity oxygenation parameters and cytokine levels
According to power analysis 90 patients have to be included in the trial A multicenter approach was chosen to finish the study within 3 years Respective to the average number of operations per institution and year the following distribution is planned Triemli Hospital 40 University Hospital Basel 30 Kantonsspital Lucerne 20 Inclusion criteria for this trial are patients undergoing thoraco-abdomino-cervical or abdomino-thoracic esophagectomy for cancer between 20 and 90 years and given informed consent Exclusion criteria are known allergy or hypersensitivity to NAC and pregnancy Patients are randomised to receive either high dose N-Acetylcysteine administered perioperatively and postoperatively for three days 150mgkg perioperatively and 50mgkg days 1-3 or placebo glucose 5
Pre- peri- and postoperatively cytokines IL-1 IL-1ra IL-6 IL-8 IL-10 TNF-α are quantified by enzyme-linked immuno assay ELISA from blood broncho-alveolar lavage and lavage of pleural space Leucocytes C-reactive protein Procalcitonin and oxygenation parameters arterial blood gas analyses ABGA are regularly measured Morbidity and mortality is assessed Furthermore all patients are asked to complete a quality of life questionnaire EORTC QLQ-OES18 and 30 SF-36 before and after the operation 12 24 36 months post-op
According to power analysis 90 patients have to be included in the trial A multicenter approach was chosen to finish the study within 3 years Respective to the average number of operations per institution and year the following distribution is planned Triemli Hospital 40 University Hospital Basel 30 Kantonsspital Lucerne 20 Inclusion criteria for this trial are patients undergoing thoraco-abdomino-cervical or abdomino-thoracic esophagectomy for cancer between 20 and 90 years and given informed consent Exclusion criteria are known allergy or hypersensitivity to NAC and pregnancy Patients are randomised to receive either high dose N-Acetylcysteine administered perioperatively and postoperatively for three days 150mgkg perioperatively and 50mgkg days 1-3 or placebo glucose 5
Pre- peri- and postoperatively cytokines IL-1 IL-1ra IL-6 IL-8 IL-10 TNF-α are quantified by enzyme-linked immuno assay ELISA from blood broncho-alveolar lavage and lavage of pleural space Leucocytes C-reactive protein Procalcitonin and oxygenation parameters arterial blood gas analyses ABGA are regularly measured Morbidity and mortality is assessed Furthermore all patients are asked to complete a quality of life questionnaire EORTC QLQ-OES18 and 30 SF-36 before and after the operation 12 24 36 months post-op
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