NCT07346365

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
74mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jan 2026Jun 2032

First Submitted

Initial submission to the registry

November 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

5.9 years

First QC Date

November 25, 2025

Last Update Submit

January 14, 2026

Conditions

ERCPPancreas StentPost-ERCP PancreatitisProphylactic Pancreatic StentStent Dislodgement

Keywords

ercpprophylactic pancreatic stentpost-ercp-pancreatitispancreatic stentpost-ercp pancreatitisPEP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Spontaneous dislocation

    From enrollment to the end of treatment 6 months

  • Follow-up examinations for pancreatic stent detection

    From enrollment to the end of treatment at 6 months

  • ERCP procedures

    During visit Nr 1 (Day 10 after enrollment)

  • Days of hospital stay

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

  • Explorative analysis of the collected data

    Through study completion, an average of 1 year

Study Arms (2)

Standard

ACTIVE COMPARATOR

Standard time of the removal

Device: standard group

Interventional - delayed removal

EXPERIMENTAL

Stent removal after 1 - 3 months

Device: pancreatic stent removal

Interventions

standard groupDEVICE

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

Standard
pancreatic stent removalDEVICE

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

Interventional - delayed removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt, Germany

Location

Related Publications (3)

  • 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.

    PMID: 39222928RESULT

  • 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: 30502123RESULT

  • 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: 31863440RESULT

Central Study Contacts

Florian Michael, Dr. med.

CONTACT

004915117191302Fmichael@med.uni-frankfurt.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician at Clinic of Gastroenterology, Johann Wolfgang Goethe University Hospital

Study Record Dates

First Submitted

November 25, 2025

First Posted

January 16, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

June 1, 2032

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)