Clinical trial NCT03161886: A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
Official title: A Treat-to-target Strategy Using Pan-enterica Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Children, Only
Keywords: colon capsule endoscopy
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.

Detailed description: This first prospective study on mucosal healing (MH) and deep remission (DR) in pediatric Crohn's Disease aims to evaluate:

* The ability of Pan-enteric capsule endoscopy (PCE) to assess MH and DR rates at three time points and to guide a treat-to-target strategy was the primary outcome sought.
* The efficacy of a "treat-to-target" strategy to MH and DR rates over 24 and 52 weeks was evaluated as a secondary outcome;
* Comparison between PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS) in evaluating intestinal inflammation.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Crohn's Disease made at least 3 months before the enrolment;
* subject was referred for endoscopic and imaging follow-up in Crohn's Disease
* signed informed consent.

Exclusion Criteria:

* Subject has dysphagia
* Subject has renal insufficiency
* Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
* Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.

Primary outcomes:
measure: Monitoring mucosal healing
timeFrame: 52 weeks
measure: Monitoring deep remission
timeFrame: 52 weeks
Secondary outcomes:
measure: Treat to Target
timeFrame: 52 weeks
measure: Diagnostic Yield
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Sapienza - University of Rome, Azienda Policlinico Umberto I
name: Salvatore Oliva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliva S, Cucchiara S, Civitelli F, Casciani E, Di Nardo G, Hassan C, Papoff P, Cohen SA. Colon capsule endoscopy compared with other modalities in the evaluation of pediatric Crohn's disease of the small bowel and colon. Gastrointest Endosc. 2016 May;83(5):975-83. doi: 10.1016/j.gie.2015.08.070. Epub 2015 Sep 9.
citation: Oliva S, Aloi M, Viola F, Mallardo S, Civitelli F, Maccioni F, Hassan C, Papoff P, Cucchiara S, Cohen SA. A Treat to Target Strategy Using Panenteric Capsule Endoscopy in Pediatric Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2060-2067.e1. doi: 10.1016/j.cgh.2018.10.015. Epub 2018 Oct 13.