Symptomatic Fluid Collection(s)PERSEUS-INCT07743762

Percutaneous Versus EUS-guided Drainage of Symptomatic Fluid Collections After Left Pancreatectomy

A study testing Plastic double pigtail stent and Percutaneous catheter in people with Symptomatic Fluid Collection(s), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Fluid collections are a complication after pancreatic surgery. These fluid collections can be treated with two treatment options. One option is percutaneous drainage, where an external drainage tube is placed in the collection. The second option is endoscopic ultrasound-guided drainage (EUS) with a stent. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Symptomatic Fluid Collection(s)
What is being tested?: Plastic double pigtail stent and Percutaneous catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteNetherlands
Study dates: 1 Aug 2026to 1 May 2030
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
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 years
Symptomatic fluid collection following a left pancreatectomy requiring drainage according to the treatment team. Indications for drainage exists of:
Symptoms of abdominal pain and/or persistent nausea.
Suspected infection/ sepsis
Drainage of the fluid collection is feasible both endoscopically and percutaneously as per the treating team. NB: Preferably this is also assessed and supported by the expert panel, but this is NOT mandatory given the potential urgent nature of the intervention. The investigators expect that multidisciplinary consultation with both intervening specialties precedes the feasibility assessment.
No contraindications for either procedure. If the contraindication can be overcome safely, such as ascites for which prior abdominal drainage is needed, the patient can still be included.
No prior drainage attempts of the fluid collection.
In case of a previously intraoperatively placed drain, it should have been removed 5 days prior to fluid collection development.

Who cannot join

<18 years
The fluid collection is not endoscopically or percutaneously feasible per the expert panel's judgement or the treatment team in acute situations, for example due to collection location too far from the gastrointestinal tract.
Prior drainage attempts of the fluid collection.
Received an indwelling percutaneous drain intraoperatively. Intraoperatively placed drains are only permitted when at least removed 5 days prior to development of the fluid collection.
Permanent incapacitation of research participant, prior to clinical deterioration caused by the pancreatic fluid collection, without expectation of improvement as per the treatment team.
Unable to obtain informed consent by either patient or their legal representative.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Inge de Vries contact

+31204440613

i.devries@amsterdamumc.nl

Netherlands1 site

Amsterdam UMC, location VUmc
Amsterdam, 1081 HV
Inge de Vries, +31204440613, i.devries@amsterdamumc.nl

Other trials in Netherlands

About this study

Official title: Percutaneous Versus EUS-guided Drainage of Symptomatic Fluid Collections After Left Pancreatectomy (PERSEUS-I): an International Randomized Controlled Trial

The goal of this clinical trial is to compare percutaneous drainage with EUS-guided drainage. The main questions it aims to answer are:

Is EUS-guided drainage of symptomatic fluid collections non-inferior to percutaneous catheter drainage in terms of safety?
Is EUS-guided drainage superior in terms of 30-day quality of life, compared to percutaneous drainage?

Researchers will compare EUS-guided drainage with percutaneous drainage to see if they are similar in safety outcomes and different in quality-of-life outcomes.

Participants will:

Be randomized between percutaneous drainage and EUS-guided drainage.
Fill-out surveys and pain score when they start the study, and then after 1 week and 3 months.
Fill-out an extra pain score on day 1 and day 3.
Receive a phone call from the study team after 1 month, where they will be asked how they are doing. Together with the study team member they fill out the surveys that are taken after 1 month.

Conditions: Symptomatic Fluid Collection(s)
Being tested: Plastic double pigtail stent, Percutaneous catheter
Keywords: EUS-guided drainage, Percutaneous drainage, Endoscopic Ultrasound, Pancreas Surgery, Left pancreatectomy, Fluid collection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plastic double pigtail stentDevice
EUS-guided placement of plastic double pigtail stent in fluid collection.
Percutaneous catheterDevice
Percutaneous catheter with external collection bag is placed in the fluid collection

Study groups in NCT07743762
Study group	Role	What they receive
Endoscopic ultrasound (EUS)-guided drainage	Experimental	Not described Receives: Device: Plastic double pigtail stent
Percutaneous catheter drainage	Active comparator	Not described Receives: Device: Percutaneous catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of procedure (absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification)
Non-inferiority analysis, absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification. The AGREE-grading ranges from Grade I to Grade V. The severity of the adverse event increases with the grade, grade I is non-exhaustive defined as deviation from the post-procedural course, grade V is defined by the death of a patient.
Measured: 30-day
Co-primary: Quality of Life measured by the Physical Component Summary (PCS) from the 12-item Short Form Health Survey
Superiority analysis, measured by the Physical Component Summary (PCS) from the 12-item short form health survey (SF-12). The SF-12 measures quality of life by physical (PCS) and mental health (MCS) scores, and is an abbreviated version of the 36-item short form health survey (SF-36). The PCS outcome ranges from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The PCS is described by 4 domains: bodily functioning, physical role limitation, pain and general perceived health.
Measured: 30-day

Secondary outcomes (25)

Quality of life by the Mental Component Score (MCS) from the 12-Item Short Form Health Survey (SF-12)
The SF-12 measures quality of life by physical (PCS) and mental health (MCS) scores, and is an abbreviated version of the 36-item short form health survey (SF-36). The MCS outcomes scores range from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The MCS is described by the following 4 domains: vitality, social functioning, emotional role limitation and mental health.
Measured: Baseline, day 7, day 30, day 90
Quality of life by the Physical Component Summary (PCS) from the 12-Item Short Form Survey for quality of life (SF-12)
The SF-12 measures quality of life by physical (PCS) and mental health (MCS) scores, and is an abbreviated version of the 36-item short form health survey (SF-36). The PCS outcome ranges from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The PCS is described by 4 domains: bodily functioning, physical role limitation, pain and general perceived health.
Measured: Baseline, day 7, day 30, day 90
Quality of life by the Numeric Rating Score (NRS)
The NRS is an 11-point scale from 0 to 10, measuring pain. One number can be chosen to define the pain severity. 0 is defined as no pain, while 10 is the worst pain imagineable.
Measured: Baseline, day 1, day 3, day 7, 30 days, 90 days
Quality of life by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
The EQ-5D-5L questionnaire measures 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions have 5 levels ranging from no problems to extreme problems. Each answer comprises a number, which forms an index at the end of the survey which can be translated to the quality of life outcome. Lastly, a visual analogue scale (VAS) records self-reported health from 0-100, the lowest defined as "the worst health you can imagine", while the highest is defined as "the best health you can imagine".
Measured: Baseline, day 7, day 30, day 90
Clinical success, relief of presenting symptoms or resolution of collection on imaging
Presenting symptoms such as abdominal pain, persistent nausea, suspected infection/sepsis. Resolution on cross-sectional imaging.
Measured: 30 days
Technical success index procedure
Defined as successful completion of the intended index procedure
Measured: During index procedure
Confirmed postoperative pancreatic fistula rate (POPF)
Following after amylase testing in collected fluid >3 times normal upper serum limit.
Measured: During 90-day follow-up
Postoperative pancreatic fistula (POPF) classification
After confirmed POPF, following the International Study Group for Pancreatic Surgery (ISGPS) classification. The classification has 3 grades, the lowest is ungraded: the biochemical leak or fistula, which has no clinical consequence. Subsequent grade B and C entail a clinical relevant change in therapy and confirmed amylase testing, where grade C is most severe with unfavourable outcomes (1 or more of the following: re-operation, organ failure, mortality).
Measured: During 90-day follow-up
Timing of diagnosis postoperative pancreatic fistula (POPF)
Confirmed by amylase testing, in days after surgery
Measured: During 90-day follow-up
Reintervention rate
Measured: During 90-day follow-up
Hospital and ICU stay in days
Measured: During 90-day follow-up
Readmission rate
Measured: During 90-day follow-up
Timing of diagnosis fluid collection
Days after pancreatic surgery
Measured: Pre-procedure
Timing of indication for drainage fluid collection
Per the treatment team
Measured: Pre-procedure
Time to relief of initial symptoms
in days, such as: symptoms of abdominal pain and/or persistent nausea, suspected infection/sepsis
Measured: During 90-day follow-up
Prophylactic drain placement rate
Measured: Pre-procedure
Prophylactic drain removal time
In days after drain placement
Measured: Pre-procedure
Mortality
General and (un)related
Measured: During 90-day follow-up
Number of adverse events and serious adverse events following the Adverse Events in GI Endoscopy (AGREE) classification.
The AGREE-grading is from Grade I to Grade V. The severity of the adverse event increases with the grade, grade I is non-exhaustive defined as deviation from post-procedural course, grade V defined by the death of a patient.
Measured: 30-day, 90-day
Concurrence between local physicians and expert panel
In case of acute situations
Measured: Pre-procedural
Initial discharge location following hospital discharge
Discharge locations: home, home with home care, rehabilitation facility, nursing facility or hospice care.
Measured: During 90-day follow-up
New onset of organ failure rate
Measured: During 90-day follow-up
Attainability performing index procedure <24-48 hours after drainage indication
After the indication for drainage of the fluid collection has been set, it is measured that the index procedure is performed by the center within <24-48 hours.
Measured: Index procedure
Presence of delayed gastric emptying (DGE)
According to the International Study Group of Pancreatic Surgery (ISGPS) classification. The classification has 3 grades (A, B, C), increasing in severity. The grades address the nasogastric tube duration, toleration of solid oral intake, vomiting/gastric distension presence and the use of prokinetics.
Measured: Pre-intervention and through study completion, which is 3 months after index procedure
Symptomatic recurrence rate
After relief of initial symptoms
Measured: During 90-day follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20261 May 2030

First posted4 Aug 2026
Study start1 Aug 2026 (estimated)
Primary completion1 Nov 2029 (estimated)
Study completion1 May 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Symptomatic Fluid Collection(s)Studies of the same condition, open and under way.
More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07743762
Sponsor's protocol ID: NL-010608
Other IDs: NL-OMON61373, 2025.1178
Acronym: PERSEUS-I
Status last verified: Jul 2026
First submitted: 21 Jul 2026
Last updated: 4 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Percutaneous Versus EUS-guided Drainage of Symptomatic Fluid Collections After Left Pancreatectomy (PERSEUS-I): an International Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07743762
Acronym / sponsor ID: PERSEUS-I / NL-010608
Conditions: Symptomatic Fluid Collection(s)
Keywords: EUS-guided drainage, Percutaneous drainage, Endoscopic Ultrasound, Pancreas Surgery, Left pancreatectomy, Fluid collection
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 96 participants (estimated)
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
Collaborators: Azienda Ospedaliera Universitaria Integrata Verona, Leiden University Medical Center, Radboud University Medical Center, St. Antonius Hospital, OLVG, University Medical Center Groningen, Maastricht University Medical Center, Medisch Spectrum Twente, Catharina Ziekenhuis Eindhoven, University Hospital Heidelberg, Erasmus Medical Center, IRCCS San Raffaele, Orlando Health, Inc., Universitaire Ziekenhuizen KU Leuven, University Hospital, Ghent
Study start: 1 Aug 2026 (estimated)
Primary completion: 1 Nov 2029 (estimated)
Study completion: 1 May 2030 (estimated)
First posted: 4 Aug 2026 (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.

The goal of this clinical trial is to compare percutaneous drainage with EUS-guided drainage. The main questions it aims to answer are:

Is EUS-guided drainage of symptomatic fluid collections non-inferior to percutaneous catheter drainage in terms of safety?
Is EUS-guided drainage superior in terms of 30-day quality of life, compared to percutaneous drainage?

Researchers will compare EUS-guided drainage with percutaneous drainage to see if they are similar in safety outcomes and different in quality-of-life outcomes.

Participants will:

Be randomized between percutaneous drainage and EUS-guided drainage.
Fill-out surveys and pain score when they start the study, and then after 1 week and 3 months.
Fill-out an extra pain score on day 1 and day 3.
Receive a phone call from the study team after 1 month, where they will be asked how they are doing. Together with the study team member they fill out the surveys that are taken after 1 month.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Endoscopic ultrasound (EUS)-guided drainage	Experimental	Device: Plastic double pigtail stent
Percutaneous catheter drainage	Active comparator	Device: Percutaneous catheter

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

≥18 years
Symptomatic fluid collection following a left pancreatectomy requiring drainage according to the treatment team. Indications for drainage exists of:
Drainage of the fluid collection is feasible both endoscopically and percutaneously as per the treating team. NB: Preferably this is also assessed and supported by the expert panel, but this is NOT mandatory given the potential urgent nature of the intervention. The investigators expect that multidisciplinary consultation with both intervening specialties precedes the feasibility assessment.
No contraindications for either procedure. If the contraindication can be overcome safely, such as ascites for which prior abdominal drainage is needed, the patient can still be included.
No prior drainage attempts of the fluid collection.

Key exclusion criteria (6 listed)

<18 years
The fluid collection is not endoscopically or percutaneously feasible per the expert panel's judgement or the treatment team in acute situations, for example due to collection location too far from the gastrointestinal tract.
Prior drainage attempts of the fluid collection.
Received an indwelling percutaneous drain intraoperatively. Intraoperatively placed drains are only permitted when at least removed 5 days prior to development of the fluid collection.
Permanent incapacitation of research participant, prior to clinical deterioration caused by the pancreatic fluid collection, without expectation of improvement as per the treatment team.

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
Plastic double pigtail stentEUS-guided placement of plastic double pigtail stent in fluid collection.	Device	Endoscopic ultrasound (EUS)-guided drainage
Percutaneous catheterPercutaneous catheter with external collection bag is placed in the fluid collection	Device	Percutaneous catheter drainage

Primary outcome

Safety of procedure (absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification)
Time frame: 30-day
Non-inferiority analysis, absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification. The AGREE-grading ranges from Grade I to Grade V. The severity of the adverse event increases with the grade, grade I is non-exhaustive defined as deviation from the post-procedural course, grade V is defined by the death of a patient.
Co-primary: Quality of Life measured by the Physical Component Summary (PCS) from the 12-item Short Form Health Survey
Time frame: 30-day
Superiority analysis, measured by the Physical Component Summary (PCS) from the 12-item short form health survey (SF-12). The SF-12 measures quality of life by physical (PCS) and mental health (MCS) scores, and is an abbreviated version of the 36-item short form health survey (SF-36). The PCS outcome ranges from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The PCS is described by 4 domains: bodily functioning, physical role limitation, pain and general perceived health.

25 secondary outcomes

Quality of life by the Mental Component Score (MCS) from the 12-Item Short Form Health Survey (SF-12)
Time frame: Baseline, day 7, day 30, day 90
Quality of life by the Physical Component Summary (PCS) from the 12-Item Short Form Survey for quality of life (SF-12)
Time frame: Baseline, day 7, day 30, day 90
Quality of life by the Numeric Rating Score (NRS)
Time frame: Baseline, day 1, day 3, day 7, 30 days, 90 days
Quality of life by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Time frame: Baseline, day 7, day 30, day 90
Clinical success, relief of presenting symptoms or resolution of collection on imaging
Time frame: 30 days
Technical success index procedure
Time frame: During index procedure
Confirmed postoperative pancreatic fistula rate (POPF)
Time frame: During 90-day follow-up
Postoperative pancreatic fistula (POPF) classification
Time frame: During 90-day follow-up
Timing of diagnosis postoperative pancreatic fistula (POPF)
Time frame: During 90-day follow-up
Reintervention rate
Time frame: During 90-day follow-up
Hospital and ICU stay in days
Time frame: During 90-day follow-up
Readmission rate
Time frame: During 90-day follow-up
Timing of diagnosis fluid collection
Time frame: Pre-procedure
Timing of indication for drainage fluid collection
Time frame: Pre-procedure
Time to relief of initial symptoms
Time frame: During 90-day follow-up
Prophylactic drain placement rate
Time frame: Pre-procedure
Prophylactic drain removal time
Time frame: Pre-procedure
Mortality
Time frame: During 90-day follow-up
Number of adverse events and serious adverse events following the Adverse Events in GI Endoscopy (AGREE) classification.
Time frame: 30-day, 90-day
Concurrence between local physicians and expert panel
Time frame: Pre-procedural
Initial discharge location following hospital discharge
Time frame: During 90-day follow-up
New onset of organ failure rate
Time frame: During 90-day follow-up
Attainability performing index procedure <24-48 hours after drainage indication
Time frame: Index procedure
Presence of delayed gastric emptying (DGE)
Time frame: Pre-intervention and through study completion, which is 3 months after index procedure
Symptomatic recurrence rate
Time frame: During 90-day follow-up

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 4 Aug 2026.
Individual participant dataSharing planned: No

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.

Inge de Vries contact

+31204440613

i.devries@amsterdamumc.nl

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: opening soon, as of the sponsor's last update on 4 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 Inge de Vries (+31204440613, i.devries@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of procedure (absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification) (time frame: 30-day). 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?

On the ClinicalTrials.gov record for NCT07743762.

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 4 Aug 2026.