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

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

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.

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

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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