Pancreatic PseudocystNCT02845258
Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage
An observational study of Pancreatic Pseudocyst and Drainage, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Pseudocyst, Drainage
- What is being tested?
- Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2006to Dec 2024
- Phase
- Observational
- 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
Study population: All patients >18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage
Who may be able to join
- All patients >18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage
Who cannot join
- Patients unwilling to participate or unable to understand or sign the informed consent
- Patients with no need for pseudocyst drainage as assessed by the endosonographer
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Endoscopy Department GEA, Sahlgrenska university Hospital
Gothenburg, S-413 45
About this study
Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed in different scenarios. The cyst appearance and the drainage stents and/or technique may impact the clinical outcome.
This study is a prospective, single-center observational study on the outcome after EUS-guided drainage of pancreatic pseudocysts.
Read the detailed description
Patintes referred to Sahlgrenska University hospital for an EUS-guided drainage of a pseudocyst are eligible for inclusion. The drainage is performed at the discretion of an experienced endosonographer. Thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. Intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.
- Conditions
- Pancreatic Pseudocyst, Drainage
- Being tested
- Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)Procedure or surgery
Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS):
This procedure is to be regarded as a clinical routine procedure since a couple of years back. The type of stent (material? length? thickness?), the cyst appearance (large? infected? cyst wall thickness?) and the type of access (transgastric? transduodenal?) may however vary from patient to patient.
In this study we perform EUS-drainage using different types of equipment on a wide range of pancreatic pseudocysts of different appearance and character. All procedures are performed as recommended. The very aim of the study is to investigate which technique and Equipment is to be preferred in different scenarios.
What is being measured
The primary outcome is the main question the study is designed to answer.
Short time complication rate
The number of EUS-procedure-related complications such as bleeding, infection and death.
Measured: Uo to 48 hours
Repeated drainage frequency
A successful drainage means no need for additional drainage procedures. The need for a repeated drainage is to be regarded as a therapeutic failure. The number of repeated procedures due to the need for additional drainage is recorded.
Measured: Up to 3 months
Secondary outcomes (2)
Hospital stay
The number of days spent in hospital post-EUS-drainage
Measured: Up to 30 days
Long time complication rate
Infections and other complications related to the non-complete drainage of the pseudocyst after discharge from the hospital
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJan 2006
- Primary completionOct 2021
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic PseudocystStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Hedenström, Sahlgrenska University Hospital
- Investigators
- Riadh Sadik, Ass Prof, Study director, Sahlgrenska University Hospital, Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845258
- Sponsor's protocol ID
- Dnr 573-09
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2016
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage
- ClinicalTrials.gov ID
- NCT02845258
- Acronym / sponsor ID
- Dnr 573-09
- Conditions
- Pancreatic Pseudocyst, Drainage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2021 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 27 Jul 2016 (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.
Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed in different scenarios. The cyst appearance and the drainage stents and/or technique may impact the clinical outcome.
This study is a prospective, single-center observational study on the outcome after EUS-guided drainage of pancreatic pseudocysts.
Detailed description
Patintes referred to Sahlgrenska University hospital for an EUS-guided drainage of a pseudocyst are eligible for inclusion. The drainage is performed at the discretion of an experienced endosonographer. Thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. Intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients >18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage
Key inclusion criteria (1 listed)
- All patients >18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage
Key exclusion criteria (2 listed)
- Patients unwilling to participate or unable to understand or sign the informed consent
- Patients with no need for pseudocyst drainage as assessed by the endosonographer
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 |
|---|---|---|
| Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS): This procedure is to be regarded as a clinical routine procedure since a couple of years back. The type of stent (material? length? thickness?), the cyst appearance (large? infected? cyst wall thickness?) and the type of access (transgastric? transduodenal?) may however vary from patient to patient. In this study we perform EUS-drainage using different types of equipment on a wide range of pancreatic pseudocysts of different appearance and character. All procedures are performed as recommended. The very aim of the study is to investigate which technique and Equipment is to be preferred in different scenarios. | Procedure or surgery | – |
Primary outcome
Short time complication rate
Time frame: Uo to 48 hours
The number of EUS-procedure-related complications such as bleeding, infection and death.
Repeated drainage frequency
Time frame: Up to 3 months
A successful drainage means no need for additional drainage procedures. The need for a repeated drainage is to be regarded as a therapeutic failure. The number of repeated procedures due to the need for additional drainage is recorded.
2 secondary outcomes
Hospital stay
Time frame: Up to 30 days
Long time complication rate
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Riadh Sadik, Ass Prof study director
Sahlgrenska University Hospital, Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Pseudocyst and Drainage, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 2 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: finished, as of the sponsor's last update on 28 Apr 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short time complication rate (time frame: Uo to 48 hours). The study lists 2 primary outcomes in all. 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 28 Apr 2026.