Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent (SAFE PANCREAS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-ERCP Pancreatitis; ERCP; Stent Dislodgement; Pancreas Stent; Prophylactic Pancreatic Stent
• Intervention / Treatment: Device: standard group; Device: pancreatic stent removal

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 Type: Interventional
• Enrollment (Estimated): 358
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian Michael, Dr. med.; Phone Number: 004915117191302; Email: Fmichael@med.uni-frankfurt.de

Study Locations

• Germany
  • Frankfurt, Germany
    • Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Contact: Florian Michael, Dr. med.; Phone Number: 004915117191302; Email: Fmichael@med.uni-frankfurt.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; Standard time of the removal	Device: standard group; Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP
Experimental: Interventional - delayed removal; Stent removal after 1 - 3 months	Device: pancreatic stent removal; Removal of the pancreatic stent after 1 - 3 months after the placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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.	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	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Collaborators: University Hospital, Essen; University Hospital, Basel, Switzerland; University Hospital Freiburg; Asklepios Kliniken Hamburg GmbH; Sana Klinikum Offenbach; University of Göttingen; University Hospital, Aachen; St. Josef Hospital Bochum; SRH Wald-Klinikum Gera GmbH; Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum; Medizinische Universitätsklinik Tübingen; Helios Klinikum Krefeld; University Hospital Munich (LMU); Münster University Hospital, Germany; Universitätsklinik Würzburg; Centrum Gastroenterologie Bethanien

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: PEP; ercp; pancreatic stent; prophylactic pancreatic stent; post-ercp-pancreatitis; post-ercp pancreatitis
• Other Study ID Numbers: FloMi2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No