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NCT Number: NCT07346365

Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent

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.

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Key information

Conditions

Stent Dislodgement ERCP Pancreas Stent Post-ERCP Pancreatitis Prophylactic Pancreatic Stent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

pancreatic stent removal

Device

Removal of the pancreatic stent after 1 - 3 months after the placement

standard group

Device

Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP

Primary outcomes

  1. 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

Secondary outcomes

  1. Spontaneous dislocation

    Time frame: From enrollment to the end of treatment 6 months

    Due the examinations by ultrasound and x-ray or endoscopy, the rate of how many patients had a spontaneous dislocation will be evaluated

  2. Follow-up examinations for pancreatic stent detection

    Time frame: From enrollment to the end of treatment at 6 months

    Follow-up examinations for pancreatic stent detection - retention or spontaneous dislocation - by ultrasound, x-ray or endoscopy examination

  3. ERCP procedures

    Time frame: During visit Nr 1 (Day 10 after enrollment)

    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)

  4. Days of hospital stay

    Time frame: From the date of hospital admission (Day 1) up to hospital discharge, assessed up to 90 days.

    The total number of days participants remain hospitalized from the date of admission until the date of discharge.

  5. Explorative analysis of the collected data

    Time frame: Through study completion, an average of 1 year

    The all data collected will be evaluated and explored for factors influencing our primary endpoint

Study contacts

Contact information is provided by the study sponsor or research team.

Florian Michael, Dr. med.

CONTACT

[email protected]

004915117191302

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Asklepios Kliniken Hamburg GmbH
  • Centrum Gastroenterologie Bethanien
  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
  • Helios Klinikum Krefeld
  • Medizinische Universitätsklinik Tübingen
  • Münster University Hospital, Germany
  • SRH Wald-Klinikum Gera GmbH
  • Sana Klinikum Offenbach
  • St. Josef Hospital Bochum
  • University Hospital Freiburg
  • University Hospital Munich
  • University Hospital, Aachen
  • University Hospital, Basel, Switzerland
  • University Hospital, Essen
  • University of Göttingen
  • University of Wuerzburg

Registry information

Official study title

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

Acronym: SAFE PANCREAS

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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