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Prognostic Value of Implementing VCE on Top in Constitutional VWD-patients With GI-bleeding

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04466878
Enrollment
50
Registered
2020-07-10
Start date
2015-01-01
Completion date
2017-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Von Willebrand Diseases

Keywords

Gastrointestinal bleeding, Videocapsule endoscopy, Angiodysplasia

Brief summary

Inclusion criteria: Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included. Patients with acquired von Willebrand syndrome will not be included. Material and Methods: A 15-items survey that will be sent to the 30 centers involved in the French network for bleeding disorders (MHEMO) to identify VWD-patients referred for endoscopic exploration of at least one GI-bleeding from January 2015 to December 2017. Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included. Constitutional VWD diagnosis will be confirmed confirmed centrally in all patients by the French reference center for von Willebrand disease. A GI-bleeding episode will be defined as any overt or occult GI-bleeding (unexplained chronic iron deficiency anemia causing a drop of hemoglobin level by more than 2 g/dL from baseline). We will analyze patient characteristics, GI-bleeding pattern, VWD type/subtype, nature (gastroscopy, colonoscopy or VCE) and results of the endoscopic exploration and management that was applied: endoscopic therapy by argon plasma coagulation, on-demand/prophylactic-VWF replacement therapy, use of antiangiogenic drugs. If angiodysplasia without another bleeding source is identified, GI-bleeding will be categorized as angiodysplasia, if another lesion is identified GI-bleeding will be categorized as "no-angiodysplasia" and if no bleeding source is identified, GI-bleeding will be categorized as obscure GI-bleeding. Recurrence will be defined as evidence of overt GI-bleeding or a drop of hemoglobin level by more than 2 g/dL from baseline.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- At least one overt or occult GI-bleeding (unexplained iron deficiency anemia causing a drop of hemoglobin level by more than 2g/dL from baseline) episode between January 1st 2015 and December 31th 2017

Exclusion criteria

* acquired Von Willebrand syndrome

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy3-years follow-upDiagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy compared to conventional endoscopy alone in VWD-patients with GI-bleeding

Secondary

MeasureTime frameDescription
Risk prediction of GI-bleeding recurrence with videocapsule endoscopy2-years follow-upRecurrence-free survival after the first GI-bleeding event according to the presence of angiodysplasia on videocapsule endoscopy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026