Duodenal ObstructionBiliousNCT06642805
Bilio-pancreatic Complications of Congenital Duodenal Obstructions
An observational study of Duodenal Obstruction, run by University Hospital, Angers.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Duodenal Obstruction
- What is being tested?
- duodenal atresia
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Dec 2028to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients under 16 years who underwent surgery for duodenal atresia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Duodenal Obstruction
- Being tested
- duodenal atresia
- Medical subject headings
- Duodenal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duodenal atresiaProcedure or surgery
surgery for duodenal atresia
| Study group | Role | What they receive |
|---|---|---|
| Cohort bilious | Not described Receives: Procedure: duodenal atresia |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of biliar complication after surgical treatment of duodenal atresia
Measured: 1 year
frequency of pancreatic complication after surgical treatment of duodenal atresia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startDec 2028 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642805
- Sponsor's protocol ID
- 49RC24_0157
- Acronym
- Bilious
- Status last verified
- Feb 2026
- First submitted
- 4 Oct 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilio-pancreatic Complications of Congenital Duodenal Obstructions
- ClinicalTrials.gov ID
- NCT06642805
- Acronym / sponsor ID
- Bilious / 49RC24_0157
- Conditions
- Duodenal Obstruction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Dec 2028 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Oct 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort bilious | – | Procedure: duodenal atresia |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients under 16 years who underwent surgery for duodenal atresia
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| duodenal atresiasurgery for duodenal atresia | Procedure or surgery | Cohort bilious |
Primary outcome
frequency of biliar complication after surgical treatment of duodenal atresia
Time frame: 1 year
frequency of pancreatic complication after surgical treatment of duodenal atresia
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Related trials for Duodenal Obstruction
Active, not recruiting
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
Pancreatic Cancer Non-resectable, Bile Duct Cancer
Recruiting
GT Metabolic Magnet System in Adults With Gastrointestinal Disorders
Gastric Outlet Obstruction, Small Bowel Obstruction
RecruitingPhase 1
Study of SGR-1505 in Mature B-Cell Neoplasms
Mature B-Cell Neoplasm, Non Hodgkin Lymphoma
RecruitingPhase 2
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
Duodenal Neoplasm, Pancreatic Neoplasm
RecruitingObservational study
Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
Gastric Outlet Obstruction, Pancreatic Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Duodenal Obstruction, run by University Hospital, Angers.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurora MARIANI (0241353637 ext. +33, aurora.mariani@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of biliar complication after surgical treatment of duodenal atresia (time frame: 1 year). The study lists 2 primary outcomes in all. 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 10 Feb 2026.