Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391359
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-01-30
Brief Title:
Preventing Recurrent Idiopathic Acute Pancreatitis Through Laparoscopic Cholecystectomy PICUS-2
Sponsor:
MG Besselink
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Preventing Recurrent Idiopathic Acute Pancreatitis Through Laparoscopic Cholecystectomy PICUS-2 a Multicenter Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
PICUS-2
Brief Summary:
Rationale Annually acute pancreatitis is diagnosed in 6500 patients in the Netherlands In up to 25 of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis IAP IAP is known for its high recurrence rate It is hypothesized that microlithiasis a type of biliary pancreatitis is the most common cause of IAP Laparoscopic cholecystectomy LC is highly effective in preventing recurrence of biliary pancreatitis Currently no randomized trial has compared LC with conservative treatment in patients with IAP after adequate work-up including endoscopic ultrasound
Objective To assess the effectiveness of LC as compared to conservative treatment in patients after a first episode of EUS-negative IAP
Study design Multicenter randomized controlled trial Patients will be followed for one year after randomization
Study population Adults with a first episode of EUS-negative IAP
Intervention if applicable Laparoscopic cholecystectomy versus conservative treatment
Main study parametersendpoints The primary endpoint is pancreatitis recurrence Secondary endpoints include occurrence of biliary events complications of LC number and severity of recurrent episodes of pancreatitis quality of life QALY costs hospital and societal and cost-effectiveness
Objective To assess the effectiveness of LC as compared to conservative treatment in patients after a first episode of EUS-negative IAP
Study design Multicenter randomized controlled trial Patients will be followed for one year after randomization
Study population Adults with a first episode of EUS-negative IAP
Intervention if applicable Laparoscopic cholecystectomy versus conservative treatment
Main study parametersendpoints The primary endpoint is pancreatitis recurrence Secondary endpoints include occurrence of biliary events complications of LC number and severity of recurrent episodes of pancreatitis quality of life QALY costs hospital and societal and cost-effectiveness
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None