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Completed

NCT Number: NCT03649399

Sonographic Detection of Prophylactic Pancreatic Stents

The Retention of pancreatic stents for prophylaxis of post-ERCP pancreatitis (PEP) is assessed by abdominal x-ray according to international Guidelines. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases Stent Dislodgement

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum der J.W. Goethe-Universität

Frankfurt am Main, Germany

About this study

Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Several pharmacologic and procedure-related measurements have been established for post-ERCP pancreatitis (PEP) prophylaxis one being the placement of pancreatic duct stents in patients with high risk for PEP. The beneficial role of pancreatic stenting in the prophylaxis of PEP was demonstrated in large meta-analyses. The used stents have a high potential of self dislodgment, retained stents have to be removed endoscopically after 5-10 days. For evaluation of spontaneous stent passage abdominal x-ray ist used and accordingly retained stents removed. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient after pancreatic stent placement for prophylaxis of post-ERCP pancreatitis
  • age 18-79
  • signed informed consent

Exclusion criteria

  • any disease that rules out study participation
  • patient not legally competent to sign informed consent
  • chronic pancreatis as indication for pancreatic stenting

Treatment and study plan

Abdominal ultrasound

Diagnostic Test

Abdominal ultrasound for detection of the pancreatic stent

Primary outcomes

  1. Positive predictive value of the sonographic detection of pancreatic stents

    Time frame: 5-10 days after stent placement

    Test whether the stents can be detected reliably by ultrasound

Secondary outcomes

  1. Negative predictive value of the sonographic detection of pancreatic stents

    Time frame: 5-10 days after stent placement

    Test whether and why the stents cannot be detected reliably by ultrasound

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Sonographic Detection of Pancreatic Stents Placed for Prophylaxis of Post-ERCP Pancreatitis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2018
Registry last updated
Apr 22, 2020

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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