Clinical trial · Interventional
Enteroscopy for Early Diagnosis of Tumors in Celiac Disease
A Capsule Endoscopy and Double Balloon Enteroscopy Sequential Approach for Early Detection of Gastrointestinal Tumors in Celiac Disease: a Prospective Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Celiac disease (CD) is the most common chronic autoimmune enteropathy in Western Countries with an estimated prevalence ranging from 1:100 to 1:200. It is usually characterized by a benign course with clinical and histological remission, provided that a strict gluten-free diet (GFD) is followed by patients. Less frequently, CD can be characterized by a complicated course, when facing with a refractory disease (RCD) or with malignancies of the gastrointestinal (GI) tract, namely lymphoma and adenocarcinoma of the small bowel (SB). Different studies estimated a relative risk (RR) for neoplastic GI complications in CD ranging from 2 to 40 and from 10 to 60 for primary gut lymphoma and adenocarcinoma, respectively. Although uncommon, the discussed malignancies has a severe prognosis, reflecting the need for an early diagnosis. This project aims to establish an enteroscopic approach to improve the diagnostic timing and survival of CD patients at risk to develop SB tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Celiac Disease | — | UNRESOLVED | — |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capsule endoscopy, double balloon enteroscopy sequential use | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enteroscopy
- description
- Capsule endoscopy, double balloon enteroscopy sequential use
- interventionNames
- Device: Capsule endoscopy, double balloon enteroscopy sequential use
Primary outcomes (1)
- measure
- Identification of celiac patients at higher risk of developing small bowel neoplasia and evaluation of the the usefulness of VCE and DBE
- timeFrame
- After 18 months an interim analysis has been planned; At the end of the project, after 36 months, the achievement of the expected number of cases is planned, complete of all the statistical analysis.
- description
- Consecutive CD patients attending to the "Center for Prevention and Diagnosis of Celiac Disease", "Fondazione IRCCS CàGranda-Ospedale Maggiore Policlinico - Milano" will be prospectively evaluated.The subjects fulfilling the entry criteria giving their written consent to the study will undergo the following work-up: routineblood tests, upper GI endoscopy with biopsies; determination of histologic grading (Marsh-Oberhuber grading) and CD3/CD8 immunohistochemistry; VCE. Abdominal and small bowel ultrasounds. Further investigations will be carried out when clinically indicated. In detail: DBE when facing with positive findings at VCE. It is planned to enroll 60-80 CD patients/years and controls with an expected prevalence of tumors of 5% and 0.5% in CD and controls respectively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: i) diagnosis of celiac disease when aged over 50 years, with persistence/recurrence of gastrointestinal symptoms after 6 months on gluten free diet ii) lack of compliance to gluten free diet (defined as conscious and regular gluten ingestion for at least two years) iii) presence of alarm symptoms/signs, either at diagnosis or during the follow up Exclusion Criteria: * age lower than 18 years * absence of written informed consent to participate in the study
References
Publications (0)
Data not yet available