Idiopathic Acute PancreatitisPICUS-2NCT06391359
Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)
A study testing Laparoscopic cholecystectomy and Watchful waiting in people with Idiopathic Acute Pancreatitis, run by M.G. Besselink at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Acute Pancreatitis
- What is being tested?
- Laparoscopic cholecystectomy and Watchful waiting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Jul 2023to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Eligible for early (laparoscopic)* cholecystectomy
- Full required diagnostic work-up of patient has been performed, including EUS
- First, second or third episode of IAP, of which at least one episode characterized by a 'negative-EUS'' result
- Informed consent for participation was obtained *if required open cholecystectomy is allowed
Who cannot join
- Patients with more than 3 episodes of acute pancreatitis
- Diagnosis of chronic pancreatitis
- Diagnosis of necrotizing pancreatitis
- Current pancreatic malignancy
- Prior cholecystectomy
- Documented etiology of acute pancreatitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location University of Amsterdam
Amsterdam, North Holland, 1081 HV
About this study
Official title: Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2): a Multicenter Randomized Trial
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, second or third episode of an 'EUS-negative' IAP.
Read more
Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization.
Study population: Adults with a first, second or third episode of IAP, of which at least one episode is characterized by a 'negative EUS'.
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.
- Conditions
- Idiopathic Acute Pancreatitis
- Being tested
- Laparoscopic cholecystectomy, Watchful waiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
Watchful waitingOther
Watchful waiting
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cholecystectomy | Experimental | Not described Receives: Procedure: Laparoscopic cholecystectomy |
| Watchful waiting | Active comparator | Not described Receives: Other: Watchful waiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute pancreatitis recurrence
Acute pancreatitis recurrence, irrespective of etiology
Measured: Within 1 year after date of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Jul 2023
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.G. Besselink
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391359
- Sponsor's protocol ID
- NL82531.018.23
- Acronym
- PICUS-2
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2): a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT06391359
- Acronym / sponsor ID
- PICUS-2 / NL82531.018.23
- Conditions
- Idiopathic Acute Pancreatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- M.G. BesselinkUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, second or third episode of an 'EUS-negative' IAP.
Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization.
Study population: Adults with a first, second or third episode of IAP, of which at least one episode is characterized by a 'negative EUS'.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cholecystectomy | Experimental | Procedure: Laparoscopic cholecystectomy |
| Watchful waiting | Active comparator | Other: Watchful waiting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Eligible for early (laparoscopic)* cholecystectomy
- Full required diagnostic work-up of patient has been performed, including EUS
- First, second or third episode of IAP, of which at least one episode characterized by a 'negative-EUS'' result
- Informed consent for participation was obtained *if required open cholecystectomy is allowed
Key exclusion criteria (6 listed)
- Patients with more than 3 episodes of acute pancreatitis
- Diagnosis of chronic pancreatitis
- Diagnosis of necrotizing pancreatitis
- Current pancreatic malignancy
- Prior cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | Laparoscopic cholecystectomy |
| Watchful waitingWatchful waiting | Other | Watchful waiting |
Primary outcome
Acute pancreatitis recurrence
Time frame: Within 1 year after date of inclusion
Acute pancreatitis recurrence, irrespective of etiology
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy and Watchful waiting in people with Idiopathic Acute Pancreatitis, run by M.G. Besselink at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rolf R. B. Schwarz, MD (+31 088-320-7052, r.schwarz@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute pancreatitis recurrence (time frame: Within 1 year after date of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.