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Not yet recruiting NCT07346365

Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent

No phase Interventional Stent Dislodgement ERCP Pancreas Stent Post-ERCP Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pancreatic stent removal, standard group.
Who it may be relevant to
Registry conditions: Stent Dislodgement, ERCP, Pancreas Stent, Post-ERCP Pancreatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent: a Prospective, Randomised, Multicenter Study (SAFE PANCREAS)

Overview

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.

Interventions

  • Device pancreatic stent removal
    Removal of the pancreatic stent after 1 - 3 months after the placement
  • Device standard group
    Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP

Primary outcome measures

  • Number of participants with treatment-related adverse events [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • prophylactic pancreatic stent (5Fr 4cm length)
  • informed consent

Exclusion criteria

  • necrotising post-ercp-pancreatitis
  • pregnancy/breastfeeding
  • Billroth II

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Johann Wolfgang Goethe-Universität Frankfurt am Main — Frankfurt

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 PMID 39222928
  • Dultz 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. PMID 30502123
  • Dumonceau 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. PMID 31863440

Identifiers

NCT: NCT07346365 · FloMi2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗