Idiopathic PancreatitisNCT00784355
Laparoscopic Cholecystectomy in Idiopathic Pancreatitis
A study testing Laparoscopic cholecystectomy in people with Idiopathic Pancreatitis, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The causes of acute pancreatitis in Finland are alcohol overuse (60%), cholecystolithiasis (20%) and idiopathic (i.e. etiology unknown)(20%). Acute pancreatitis may recur in over half of cases and may be fatal in severe cases in 30%. Majority of idiopathic pancreatitis are caused by microlithiasis in gall bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pancreatitis
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic pancreatitis
Who cannot join
- age < 18 years old
- patients' refusal
- high operative risks
- alcohol overuse
Trial locations and contacts
1 site in 1 country.
Sari Paajanen, MD, PhD contact
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, 70211
Hannu Paajanen, MD, PhD, hannu.paajanen@esshp.fi
Sari Gronlund, MD, PhD, sari.gronlund@kuh.fi
About this study
Official title: Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study
The causes of acute pancreatitis in Finland are alcohol overuse (60%), cholecystolithiasis (20%) and idiopathic (i.e. etiology unknown)(20%). Acute pancreatitis may recur in over half of cases and may be fatal in severe cases in 30%. Majority of idiopathic pancreatitis are caused by microlithiasis in gall bladder. The purpose of this randomized study is to prevent recurrence of idiopathic pancreatitis by performing laparoscopic cholecystectomy compared to non-operative group in 2 years follow-up of patients.
Read the detailed description
Etiologic investigations include serum amylase, lipase, triglyceride and calcium determination, as well as abdominal ultrasound scanning. Alcohol consumption is asked by using WHO audit test. After etiology of acute pancreatitis has been confirmed as idiopathic, 100 patients are randomized to laparoscopic cholecystectomy and 100 patients to follow-up of 2 years. Five to seven Finnish university and main central hospitals are participating the study.
- Conditions
- Idiopathic Pancreatitis
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- recurrence of idiopathic pancreatitis, laparoscopic cholecystectomy, etiology of pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Also called idiopathic pancreatitis, cholecystectomy
Surgery
| Study group | Role | What they receive |
|---|---|---|
| 1:Laparoscopic cholecystectomy | Experimental | Surgery Receives: Procedure: Laparoscopic cholecystectomy |
| 2:controls | No intervention | non-surgical control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of acute pancreatitis
Measured: 2 years
Secondary outcomes (1)
etiology of acute pancreatitis in Finland in 2009-10
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannu Paajanen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784355
- Sponsor's protocol ID
- KUH5200616
- Status last verified
- Aug 2018
- First submitted
- 31 Oct 2008
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Karne S, Gorelick FS. Etiopathogenesis of acute pancreatitis. Surg Clin North Am. 1999 Aug;79(4):699-710. doi: 10.1016/s0039-6109(05)70036-0.
PubMed 10470320Raty S, Pulkkinen J, Nordback I, Sand J, Victorzon M, Gronroos J, Helminen H, Kuusanmaki P, Nordstrom P, Paajanen H. Can Laparoscopic Cholecystectomy Prevent Recurrent Idiopathic Acute Pancreatitis?: A Prospective Randomized Multicenter Trial. Ann Surg. 2015 Nov;262(5):736-41. doi: 10.1097/SLA.0000000000001469.
PubMed 26583660
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study
- ClinicalTrials.gov ID
- NCT00784355
- Acronym / sponsor ID
- KUH5200616
- Conditions
- Idiopathic Pancreatitis
- Keywords
- recurrence of idiopathic pancreatitis, laparoscopic cholecystectomy, etiology of pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Nov 2008 (estimated)
- 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.
The causes of acute pancreatitis in Finland are alcohol overuse (60%), cholecystolithiasis (20%) and idiopathic (i.e. etiology unknown)(20%). Acute pancreatitis may recur in over half of cases and may be fatal in severe cases in 30%. Majority of idiopathic pancreatitis are caused by microlithiasis in gall bladder. The purpose of this randomized study is to prevent recurrence of idiopathic pancreatitis by performing laparoscopic cholecystectomy compared to non-operative group in 2 years follow-up of patients.
Detailed description
Etiologic investigations include serum amylase, lipase, triglyceride and calcium determination, as well as abdominal ultrasound scanning. Alcohol consumption is asked by using WHO audit test. After etiology of acute pancreatitis has been confirmed as idiopathic, 100 patients are randomized to laparoscopic cholecystectomy and 100 patients to follow-up of 2 years. Five to seven Finnish university and main central hospitals are participating the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1:Laparoscopic cholecystectomy | Experimental | Procedure: Laparoscopic cholecystectomySurgery |
| 2:controls | No intervention | –non-surgical control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- idiopathic pancreatitis
Key exclusion criteria (4 listed)
- age < 18 years old
- patients' refusal
- high operative risks
- alcohol overuse
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 cholecystectomyAlso: idiopathic pancreatitis, cholecystectomySurgery | Procedure or surgery | 1:Laparoscopic cholecystectomy |
Primary outcome
recurrence of acute pancreatitis
Time frame: 2 years
1 secondary outcome
etiology of acute pancreatitis in Finland in 2009-10
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Background: PubMed 10470320Karne S, Gorelick FS. Etiopathogenesis of acute pancreatitis. Surg Clin North Am. 1999 Aug;79(4):699-710. doi: 10.1016/s0039-6109(05)70036-0.
- Derived from this study: PubMed 26583660Raty S, Pulkkinen J, Nordback I, Sand J, Victorzon M, Gronroos J, Helminen H, Kuusanmaki P, Nordstrom P, Paajanen H. Can Laparoscopic Cholecystectomy Prevent Recurrent Idiopathic Acute Pancreatitis?: A Prospective Randomized Multicenter Trial. Ann Surg. 2015 Nov;262(5):736-41. doi: 10.1097/SLA.0000000000001469.
- Individual participant dataSharing planned: Undecided
Related trials for Idiopathic Pancreatitis
Recruiting
Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)
Idiopathic Acute Pancreatitis
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. This study is not recruiting at the moment.
Sari Paajanen, MD, PhD contact
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 in people with Idiopathic Pancreatitis, run by Kuopio University Hospital at 1 site in Finland.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannu EK Paajanen, MD, PhD (+358-44-3512220, hannu.paajanen@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of acute pancreatitis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00784355, which also lists 2 linked publications.
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 14 Aug 2018.