Establishing a Sonographic Based Algorithm to Verify Pancreatic Stent Position Placed to Prevent Post-ERCP Pancreatitis Before Endoscopic Removal

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Post-ERCP Acute Pancreatitis; X-rays; Pancreatic Stent; Ultrasound

Treatments: Diagnostic Test: Sonographic based visualization of a pancreatic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT04546867

FRA-UNI-PANCSTENT-2020

Details and patient eligibility

About

The present study is a prospective, single-center study. A total of 88 patients, who had placed a pancreatic stent for preventing post-ERCP pancreatitis, will be included in the study. Aim of the study is to establish a new algorithm based on a sonographic approach to remove the placed pancreatic stents. Another aim is to compare high-end sonographic devices with devices of medium price scale one's used on the ward.

On the day of removal of the pancreatic stent, all patients receive a sonography by an experienced investigator on the ward and by another, uninformed investigator with a high-end device. If a pancreatic stent is visualized in the pancreatic duct, the patient will have an esophagogastroduodenoscopy to remove the pancreatic stent. If sonography cannot find a pancreatic stent in the pancreatic duct an x-ray will be performed as suggested by the European and international guidelines. If the pancreatic stent spontaneously dislocated into the small bowel tract according to x-ray, no further investigation will be performed. If a stent is visulized in situ by x-ray, it will be removed by endoscopyl.

Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• placement of prophylactic pancreatic stent to prevent post-ERCP-pancreatitis
• age of at least 18 years
• written informed consent

Exclusion criteria

• diseases that prevent sonography, x-ray or esophagogastroduodenoscopy
• no given consent
• other indication for pancreatic stenting

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Sonography arm

Other group

Description:

Sonography is being performed by expericenced investigators to visualize a pancreatic stent in the pancreatic duct. If the stent is being visualized, an endoscopy will be performed to remove the stent. Otherwise, x-ray will be needed to confirm the sonographic finding of a dislodged pancreatic stent with no further need of intervention. If x-ray finds a pancreatic stent in situ opposingly to ultrasound, an endoscopy will be performed to confirm the stents position and eventually remove it.

Treatment:

Diagnostic Test: Sonographic based visualization of a pancreatic stent