Pancreatic Duct DilatationNCT05385354
Main Pancreatic Duct Diameter
An observational study of Pancreatic Duct Dilatation, run by Technical University of Munich at 1 site in Germany.
Trial summary
The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts: Pancreatic head Pancreatic neck Pancreatic body Pancreatic tail Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Duct Dilatation
- How many people
- 115 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2022to 30 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract
Who may be able to join
- Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract
- Indication for EUS is undependent from the study
- Written informed consent
- Age ≥18 years
Who cannot join
- Pancreatic diseases (chronic or acute pancreatitis, pancreatic tumor, pancreatic cyst, etc.)
- Disorders of papilla duodeni major/minor (adenoma/carcinoma of papilla duodeni major or minor)
- Biliary disorders (bile duct stones, cholangio carcinoma, cholangitis)
- Elevated Bilirubin and/or Lipase
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic and Policlinik of Internal Medicine II
Munich, Bavaria, 81675
About this study
Official title: Normal Values of Main Pancreatic Duct Diameter
The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts:
- Pancreatic head
- Pancreatic neck
- Pancreatic body
- Pancreatic tail
Read the detailed description
All patients without pancreatic or biliary disorders undergoing upper-GI endoscopic ultrasound (EUS) are eligible for the study.
The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound in millimeters at four different parts:
- Pancreatic head
- Pancreatic neck
- Pancreatic body
- Pancreatic tail
- Conditions
- Pancreatic Duct Dilatation
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal diameter of main pancreatic duct in millimeters
Measurements of main pancreatic duct at different sections of the pancreas
Measured: The measurement is performed once during endosonography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start3 May 2022
- Primary completion15 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Duct DilatationStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veit Phillip, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385354
- Sponsor's protocol ID
- MDP-1
- Status last verified
- Nov 2024
- First submitted
- 6 May 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values of Main Pancreatic Duct Diameter
- ClinicalTrials.gov ID
- NCT05385354
- Acronym / sponsor ID
- MDP-1
- Conditions
- Pancreatic Duct Dilatation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 23 May 2022 (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 maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts:
- Pancreatic head
- Pancreatic neck
- Pancreatic body
- Pancreatic tail
Detailed description
All patients without pancreatic or biliary disorders undergoing upper-GI endoscopic ultrasound (EUS) are eligible for the study.
The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound in millimeters at four different parts:
- Pancreatic head
- Pancreatic neck
- Pancreatic body
- Pancreatic tail
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract
Key inclusion criteria (4 listed)
- Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract
- Indication for EUS is undependent from the study
- Written informed consent
- Age ≥18 years
Key exclusion criteria (4 listed)
- Pancreatic diseases (chronic or acute pancreatitis, pancreatic tumor, pancreatic cyst, etc.)
- Disorders of papilla duodeni major/minor (adenoma/carcinoma of papilla duodeni major or minor)
- Biliary disorders (bile duct stones, cholangio carcinoma, cholangitis)
- Elevated Bilirubin and/or Lipase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal diameter of main pancreatic duct in millimeters
Time frame: The measurement is performed once during endosonography.
Measurements of main pancreatic duct at different sections of the pancreas
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 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Recruiting
Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)
Pancreatitis, Acute, Bleeding
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Duct Dilatation, run by Technical University of Munich 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 4 inclusion and 4 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 12 Nov 2024. 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?
Maximal diameter of main pancreatic duct in millimeters (time frame: The measurement is performed once during endosonography.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.