- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06642805
Bilio-pancreatic Complications of Congenital Duodenal Obstructions (Bilious)
February 6, 2026 updated by: University Hospital, Angers
Congenital duodenal obstructions, often grouped under the term duodenal atresias, encompass a range of malformations of the duodenum that cause partial or complete obstruction.
In the long term, the main complications described fall within the spectrum of digestive occlusions (anastomotic stenosis, obstruction due to adhesions, and duodenal dysmotility) and may require surgical revisions.
Biliary and pancreatic complications, which are embryologically logical, are reported in the form of rare clinical cases.
The aim of the research is to identify biliopancreatic complications following duodenal atresia surgery in order to characterize them, estimate their national frequency, and determine any potential iatrogenic risk factors.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aurora MARIANI
- Phone Number: +33 0241353637
- Email: aurora.mariani@chu-angers.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients under 16 years who underwent surgery for duodenal atresia
Description
Inclusion Criteria:
- Patients who underwent surgery for duodenal atresia in a pediatric surgery department participating in the study over the past 20 years,
- legal representatives did not object to data collection
Exclusion Criteria:
- Patients ≥ 16 years at the time of surgery.
- Objection from the legal representatives of the child or the adult patient to the collection and use of health data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cohort bilious
|
surgery for duodenal atresia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
frequency of biliar complication after surgical treatment of duodenal atresia
Time Frame: 1 year
|
1 year
|
|
frequency of pancreatic complication after surgical treatment of duodenal atresia
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2028
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
October 4, 2024
First Submitted That Met QC Criteria
October 14, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
February 10, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49RC24_0157
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on duodenal atresia
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