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

May 21, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

- VWD-patients fulfilling the inclusion criteria of the French reference center for VWD

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy
Time Frame: 3-years follow-up
Diagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy compared to conventional endoscopy alone in VWD-patients with GI-bleeding
3-years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk prediction of GI-bleeding recurrence with videocapsule endoscopy
Time Frame: 2-years follow-up
Recurrence-free survival after the first GI-bleeding event according to the presence of angiodysplasia on videocapsule endoscopy
2-years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

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 (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020 02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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