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

Johann Wolfgang Goethe University Hospital

Status: Not yet enrolling

Conditions: Post-ERCP Pancreatitis; ERCP; Stent Dislodgement; Pancreas Stent; Prophylactic Pancreatic Stent

Treatments: Device: pancreatic stent removal; Device: standard group

Study type: Interventional

Funder types: Other

Identifiers

NCT07346365

FloMi2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 358 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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358 participants in 2 patient groups

Standard

Active Comparator group

Description:

Standard time of the removal

Treatment:

Device: standard group

Interventional - delayed removal

Experimental group

Description:

Stent removal after 1 - 3 months

Treatment:

Device: pancreatic stent removal