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Sonographic Detection of Prophylactic Pancreatic Stents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649399
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatitis Stent Dislodgement Diagnostic Test: Abdominal ultrasound Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sonographic Detection of Pancreatic Stents Placed for Prophylaxis of Post-ERCP Pancreatitis
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with pancreatic stent
abdominal ultrasound and x-ray for stent detection.
Diagnostic Test: Abdominal ultrasound
Abdominal ultrasound for detection of the pancreatic stent




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649399


Contacts
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Contact: Mireen Friedrich-Rust, MD 00496301 ext 5122 Mireen.Friedrich-Rust@kgu.de

Locations
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Germany
Klinikum der J.W. Goethe-Universität Recruiting
Frankfurt am Main, Germany
Contact: Mireen Friedrich-Rust, MD    +496301 ext 5122    Mireen.Friedrich-Rust@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Mireen Friedrich-Rust, MD University Hospital, Frankfurt

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Responsible Party: Johannes Vermehren, Prof., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03649399    
Other Study ID Numbers: 419/17
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases