NCT07346365

Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2031-12-01
• Completion: 2032-06-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: Germany