Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535490
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevention of Infection After EUS-FNA of Pancreatic Cystic Lesions A French Multicenter Prospective Comparative Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrePaCyst
Brief Summary:
Large prospective comparative observational study in numerous reference centers in France comparing infectious complications in patients admitted for pancreatic cystic lesions PCL aspiration performed with or without antibiotic prophylaxis ATBp according to the usual practices
This is a prospective comparative observational multicenter study with the primary objective of comparing the infection rates in pancreatic cystic lesions PCL aspirated under EUS with and without the administration of ATBp
A sample size of 1702 patients will be needed over a 3-year study period
This is a prospective comparative observational multicenter study with the primary objective of comparing the infection rates in pancreatic cystic lesions PCL aspirated under EUS with and without the administration of ATBp
A sample size of 1702 patients will be needed over a 3-year study period
Detailed Description:
The complication rate after EUS fine needle aspiration EUS-FNA for pancreatic cystic lesions PCL is low around 1-3 according to various series However it has long been recommended to perform this procedure under antibiotic prophylaxis ATBp Due to the risk of developing resistance to certain classes of antibiotics and the risk of complications particularly allergic reactions the role of ATBp in this indication needs to be reconsidered The latest recommendations from European and French societies do not support the systematic formal indication of ATBp for aspiration under EUS Because the literature on the subject is sparse and equivocal practices remain varied some performing PCL aspirations with and others without ATBp and scientific societies do not provide a formal stance on the benefit of such ATBp Therefore we decided to conduct a very large prospective comparative observational study in numerous reference centers in France centers of the Research and Action Group in Endoscopy - GRAPHE comparing infectious complications in patients admitted for EUS-FNA for PCL performed with or without ATBp according to the usual practices
This is a prospective comparative observational multicenter study
Primary objective
Comparison of infection rates after EUS-FNA for pancreatic cystic lesions PCL with and without the administration of ATBp
Secondary objectives
Rates of other infectious complications pulmonary urinary etc Rates of post-ATBp complications particularly allergic reactions Prolongation of scheduled hospitalization Evaluation of factors associated with post-EUS aspiration infection of PCL
After the endoscopic exploration the patient will be monitored for the potential occurrence of complications related to EUS perforation hemorrhage infection allergy etc Any adverse events will be recorded at 30 days post-procedure
A sample size of 1702 patients will be needed over a 3-year study period
This is a prospective comparative observational multicenter study
Primary objective
Comparison of infection rates after EUS-FNA for pancreatic cystic lesions PCL with and without the administration of ATBp
Secondary objectives
Rates of other infectious complications pulmonary urinary etc Rates of post-ATBp complications particularly allergic reactions Prolongation of scheduled hospitalization Evaluation of factors associated with post-EUS aspiration infection of PCL
After the endoscopic exploration the patient will be monitored for the potential occurrence of complications related to EUS perforation hemorrhage infection allergy etc Any adverse events will be recorded at 30 days post-procedure
A sample size of 1702 patients will be needed over a 3-year study period
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