PancreatitisNCT03649399
Sonographic Detection of Prophylactic Pancreatic Stents
A study testing Abdominal ultrasound in people with Pancreatitis and Stent Dislodgement, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pancreatitis, Stent Dislodgement
- What is being tested?
- Abdominal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 21 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient after pancreatic stent placement for prophylaxis of post-ERCP pancreatitis
- age 18-79
- signed informed consent
Who cannot join
- any disease that rules out study participation
- patient not legally competent to sign informed consent
- chronic pancreatis as indication for pancreatic stenting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonographic Detection of Pancreatic Stents Placed for Prophylaxis of Post-ERCP Pancreatitis
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.
Read the 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.
- Conditions
- Pancreatitis, Stent Dislodgement
- Being tested
- Abdominal ultrasound
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasoundDiagnostic test
Abdominal ultrasound for detection of the pancreatic stent
| Study group | Role | What they receive |
|---|---|---|
| Patients with pancreatic stent | Experimental | abdominal ultrasound and x-ray for stent detection. Receives: Diagnostic Test: Abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of the sonographic detection of pancreatic stents
Test whether the stents can be detected reliably by ultrasound
Measured: 5-10 days after stent placement
Secondary outcomes (1)
Negative predictive value of the sonographic detection of pancreatic stents
Test whether and why the stents cannot be detected reliably by ultrasound
Measured: 5-10 days after stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Mar 2018
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Dultz, Johann Wolfgang Goethe University Hospital
- Investigators
- Mireen Friedrich-Rust, MD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649399
- Sponsor's protocol ID
- 419/17
- Status last verified
- Apr 2020
- First submitted
- 25 Aug 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michael FA, Gerber L, Weiler N, Hunyady PM, Abedin N, de la Vera AL, Stoffers P, Filmann N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. Transabdominal ultrasonography to reduce the burden of X-ray imaging in prophylactic pancreatic stent localization after ERCP-A prospective trial. United European Gastroenterol J. 2021 May;9(4):469-477. doi: 10.1002/ueg2.12063. Epub 2021 Apr 22.
PubMed 33887119
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Detection of Pancreatic Stents Placed for Prophylaxis of Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT03649399
- Acronym / sponsor ID
- 419/17
- Conditions
- Pancreatitis, Stent Dislodgement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreatic stent | Experimental | Diagnostic Test: Abdominal ultrasoundabdominal ultrasound and x-ray for stent detection. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient after pancreatic stent placement for prophylaxis of post-ERCP pancreatitis
- age 18-79
- signed informed consent
Key exclusion criteria (3 listed)
- any disease that rules out study participation
- patient not legally competent to sign informed consent
- chronic pancreatis as indication for pancreatic stenting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal ultrasoundAbdominal ultrasound for detection of the pancreatic stent | Diagnostic test | Patients with pancreatic stent |
Primary outcome
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
1 secondary outcome
Negative predictive value of the sonographic detection of pancreatic stents
Time frame: 5-10 days after stent placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 33887119Michael FA, Gerber L, Weiler N, Hunyady PM, Abedin N, de la Vera AL, Stoffers P, Filmann N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. Transabdominal ultrasonography to reduce the burden of X-ray imaging in prophylactic pancreatic stent localization after ERCP-A prospective trial. United European Gastroenterol J. 2021 May;9(4):469-477. doi: 10.1002/ueg2.12063. Epub 2021 Apr 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireen Friedrich-Rust, MD principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal ultrasound in people with Pancreatitis and Stent Dislodgement, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value of the sonographic detection of pancreatic stents (time frame: 5-10 days after stent placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03649399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.