Amsterdam UMC, location University of Amsterdam
Amsterdam, North Holland, 1081 HV, Netherlands
Location status: Recruiting
Recruiting
NCT Number: NCT06391359
Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)
Rationale: Annually, acute pancreatitis is diagnosed in 6,500 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 parameters/endpoints: 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- At least 18 years old
- Eligible for early (laparoscopic)* cholecystectomy
- Full required diagnostic work-up of patient has been performed, including EUS
- First episode of 'EUS-negative' IAP
- Informed consent for participation was obtained *if required open cholecystectomy is allowed
Exclusion criteria
- Recurrent acute pancreatitis
- Diagnosis of chronic pancreatitis
- Diagnosis of necrotizing pancreatitis
- Current pancreatic malignancy
- Prior cholecystectomy
- Documented etiology of acute pancreatitis
Treatment and study plan
Laparoscopic cholecystectomy
ProcedureLaparoscopic cholecystectomy
Watchful waiting
OtherWatchful waiting
Primary outcomes
-
Acute pancreatitis recurrence
Time frame: Within 1 year after date of inclusion
Acute pancreatitis recurrence, irrespective of etiology
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
M.G. Besselink
Other
Registry information
Official study title
Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2): a Multicenter Randomized Trial
Acronym: PICUS-2
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Apr 30, 2024
- Registry last updated
- Apr 30, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.