NCT06642805

Brief 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 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Dec 2028

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
4.1 years until next milestone

Study Start

First participant enrolled

December 1, 2028

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

Same day

First QC Date

October 4, 2024

Last Update Submit

February 6, 2026

Conditions

Duodenal Obstruction

Outcome Measures

Primary Outcomes (2)

  • frequency of biliar complication after surgical treatment of duodenal atresia

    1 year

  • frequency of pancreatic complication after surgical treatment of duodenal atresia

    1 year

Study Arms (1)

Cohort bilious

Procedure: duodenal atresia

Interventions

duodenal atresiaPROCEDURE

surgery for duodenal atresia

Cohort bilious

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients under 16 years who underwent surgery for duodenal atresia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Duodenal Obstruction

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesIntestinal Obstruction

Central Study Contacts

Aurora MARIANI

CONTACT

0241353637aurora.mariani@chu-angers.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 15, 2024

Study Start (Estimated)

December 1, 2028

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

February 10, 2026

Record last verified: 2026-02