Stent DislodgementSAFE PANCREASNCT07346365
Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent
A study testing pancreatic stent removal and standard group in people with Stent Dislodgement and ERCP, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
A multicenter, prospective, controlled randomized study to investigate the optimal duration of protective pancreatic stents after endoscopic retrograde cholangiopancreatography (ERCP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stent Dislodgement, ERCP, Pancreas Stent
- What is being tested?
- pancreatic stent removal and standard group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2026to Jun 2032
- 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
- prophylactic pancreatic stent (5Fr 4cm length)
- informed consent
Who cannot join
- necrotising post-ercp-pancreatitis
- pregnancy/breastfeeding
- Billroth II
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt
Florian Michael, Dr. med., 004915117191302, Fmichael@med.uni-frankfurt.de
About this study
Official title: Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent: a Prospective, Randomised, Multicenter Study (SAFE PANCREAS)
A multicenter, prospective, controlled randomized study to investigate the optimal duration of protective pancreatic stents after endoscopic retrograde cholangiopancreatography (ERCP).
The primary endpoint is the complication rate that can be clinically attributed to the remaining pancreatic prosthesis or its removal in the study groups. Secondary endpoints are spontaneous removal of the pancreatic stent, length of hospital stay, rate of follow-up examinations per group, influencing factors, and a possible exploratory analysis.
Read the detailed description
After study consent, randomization takes place into the standard group (removal of the protective pancreatic stent after 12 hours at the earliest and 10 days at the latest by esophagogastroduodenoscopy/ERCP) or into the intervention group (removal of the protective pancreatic stent after 4 weeks at the earliest, but no later than 3 months).
Both the baseline data and randomization are planned on a secure online platform (http://myresearchmanager.com).
Before removing the pancreatic stent, non-invasive diagnostics may be performed in accordance with hospital standards, and endoscopy may be omitted if the pancreatic stent is found to be displaced.
- Conditions
- Stent Dislodgement, ERCP, Pancreas Stent, Post-ERCP Pancreatitis, Prophylactic Pancreatic Stent
- Being tested
- pancreatic stent removal, standard group
- Keywords
- ercp, prophylactic pancreatic stent, post-ercp-pancreatitis, pancreatic stent, post-ercp pancreatitis, PEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic stent removalDevice
Removal of the pancreatic stent after 1 - 3 months after the placement
standard groupDevice
Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Standard time of the removal Receives: Device: standard group |
| Interventional - delayed removal | Experimental | Stent removal after 1 - 3 months Receives: Device: pancreatic stent removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Side effects (number and type) which occur due to the stent insertion, retention after more than 10 days and/or after the removal of the stent
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (5)
Spontaneous dislocation
Due the examinations by ultrasound and x-ray or endoscopy, the rate of how many patients had a spontaneous dislocation will be evaluated
Measured: From enrollment to the end of treatment 6 months
Follow-up examinations for pancreatic stent detection
Follow-up examinations for pancreatic stent detection - retention or spontaneous dislocation - by ultrasound, x-ray or endoscopy examination
Measured: From enrollment to the end of treatment at 6 months
ERCP procedures
Influence of measures taken during ERCP on the probability of spontaneous stent dislocation as well of patients characteristics (pancreaticobiliary disease)
- questions about procedures made during the ERCP (papillotomy, stent insertion, using metallic stent, balloon dilatation)
- questions about patients characteristics (chronic pancreatitis, pancreatic tumor, cholangiocarcinoma, stone extraction)
Measured: During visit Nr 1 (Day 10 after enrollment)
Days of hospital stay
The total number of days participants remain hospitalized from the date of admission until the date of discharge.
Measured: From the date of hospital admission (Day 1) up to hospital discharge, assessed up to 90 days.
Explorative analysis of the collected data
The all data collected will be evaluated and explored for factors influencing our primary endpoint
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stent DislodgementStudies 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
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SRH Wald-Klinikum Gera GmbH, Asklepios Kliniken Hamburg GmbH, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Helios Klinikum Krefeld, Sana Klinikum Offenbach, St. Josef Hospital Bochum, University Hospital, Aachen, University Hospital, Essen, University Hospital Freiburg, University Hospital Muenster, University Hospital Tuebingen, University of Göttingen, University Hospital, Basel, Switzerland, Centrum Gastroenterologie Bethanien, University Hospital Munich, University of Wuerzburg
- Responsible party
- Principal investigator, Georg Dultz, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346365
- Sponsor's protocol ID
- FloMi2025
- Acronym
- SAFE PANCREAS
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michael FA, Feldmann C, Erasmus HP, Kubesch A, Goerguelue E, Knabe M, Abedin N, Heilani M, Hessz D, Graf C, Walter D, Finkelmeier F, Mihm U, Lingwal N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. A novel ultrasound-based algorithm for the detection of pancreatic stents placed for prophylaxis of post-ERCP pancreatitis: a prospective trial. Ultraschall Med. 2025 Apr;46(2):177-185. doi: 10.1055/a-2407-9651. Epub 2024 Sep 2.
PubMed 39222928Dultz G, Gerber L, Zeuzem S, Bojunga J, Friedrich-Rust M. Prolonged retention of prophylactic pancreatic stents is not associated with increased complications. Pancreatology. 2019 Jan;19(1):39-43. doi: 10.1016/j.pan.2018.11.011. Epub 2018 Nov 22.
PubMed 30502123Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent: a Prospective, Randomised, Multicenter Study (SAFE PANCREAS)
- ClinicalTrials.gov ID
- NCT07346365
- Acronym / sponsor ID
- SAFE PANCREAS / FloMi2025
- Conditions
- Stent Dislodgement, ERCP, Pancreas Stent, Post-ERCP Pancreatitis, Prophylactic Pancreatic Stent
- Keywords
- ercp, prophylactic pancreatic stent, post-ercp-pancreatitis, pancreatic stent, post-ercp pancreatitis, PEP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- SRH Wald-Klinikum Gera GmbH, Asklepios Kliniken Hamburg GmbH, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Helios Klinikum Krefeld, Sana Klinikum Offenbach, St. Josef Hospital Bochum, University Hospital, Aachen, University Hospital, Essen, University Hospital Freiburg, University Hospital Muenster, University Hospital Tuebingen, University of Göttingen, University Hospital, Basel, Switzerland, Centrum Gastroenterologie Bethanien, University Hospital Munich, University of Wuerzburg
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 16 Jan 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.
A multicenter, prospective, controlled randomized study to investigate the optimal duration of protective pancreatic stents after endoscopic retrograde cholangiopancreatography (ERCP).
The primary endpoint is the complication rate that can be clinically attributed to the remaining pancreatic prosthesis or its removal in the study groups. Secondary endpoints are spontaneous removal of the pancreatic stent, length of hospital stay, rate of follow-up examinations per group, influencing factors, and a possible exploratory analysis.
Detailed description
After study consent, randomization takes place into the standard group (removal of the protective pancreatic stent after 12 hours at the earliest and 10 days at the latest by esophagogastroduodenoscopy/ERCP) or into the intervention group (removal of the protective pancreatic stent after 4 weeks at the earliest, but no later than 3 months).
Both the baseline data and randomization are planned on a secure online platform (http://myresearchmanager.com).
Before removing the pancreatic stent, non-invasive diagnostics may be performed in accordance with hospital standards, and endoscopy may be omitted if the pancreatic stent is found to be displaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Device: standard groupStandard time of the removal |
| Interventional - delayed removal | Experimental | Device: pancreatic stent removalStent removal after 1 - 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- prophylactic pancreatic stent (5Fr 4cm length)
- informed consent
Key exclusion criteria (3 listed)
- necrotising post-ercp-pancreatitis
- pregnancy/breastfeeding
- Billroth II
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 stent removalRemoval of the pancreatic stent after 1 - 3 months after the placement | Device | Interventional - delayed removal |
| standard groupRemoval at intervals of 12 hours up to a maximum of 10 days after the index ERCP | Device | Standard |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: From enrollment to the end of treatment at 6 months
Side effects (number and type) which occur due to the stent insertion, retention after more than 10 days and/or after the removal of the stent
5 secondary outcomes
Spontaneous dislocation
Time frame: From enrollment to the end of treatment 6 months
Follow-up examinations for pancreatic stent detection
Time frame: From enrollment to the end of treatment at 6 months
ERCP procedures
Time frame: During visit Nr 1 (Day 10 after enrollment)
Days of hospital stay
Time frame: From the date of hospital admission (Day 1) up to hospital discharge, assessed up to 90 days.
Explorative analysis of the collected data
Time frame: Through study completion, an average of 1 year
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 16 Jan 2026.
- Results publication: PubMed 39222928Michael FA, Feldmann C, Erasmus HP, Kubesch A, Goerguelue E, Knabe M, Abedin N, Heilani M, Hessz D, Graf C, Walter D, Finkelmeier F, Mihm U, Lingwal N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. A novel ultrasound-based algorithm for the detection of pancreatic stents placed for prophylaxis of post-ERCP pancreatitis: a prospective trial. Ultraschall Med. 2025 Apr;46(2):177-185. doi: 10.1055/a-2407-9651. Epub 2024 Sep 2.
- Results publication: PubMed 30502123Dultz G, Gerber L, Zeuzem S, Bojunga J, Friedrich-Rust M. Prolonged retention of prophylactic pancreatic stents is not associated with increased complications. Pancreatology. 2019 Jan;19(1):39-43. doi: 10.1016/j.pan.2018.11.011. Epub 2018 Nov 22.
- Results publication: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreatic stent removal and standard group in people with Stent Dislodgement and ERCP, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 2 inclusion and 3 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 16 Jan 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 Germany. 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 Florian Michael, Dr. med. (004915117191302, Fmichael@med.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: From enrollment to the end of treatment at 6 months). 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 NCT07346365, which also lists 3 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 16 Jan 2026.