Introduction
Crohn's disease (CD) is a heterogeneous condition that can affect the entire gastrointestinal tract, with isolated small bowel (SB) involvement occurring in 20–30% of patients. According to ECCO and other international guidelines, the standard diagnostic approach for CD includes ileocolonoscopy and cross-sectional SB imaging. When these modalities yield inconclusive results, video capsule endoscopy (VCE) is recommended for evaluating SB mucosa. Despite negative findings on comprehensive evaluations, a significant proportion of patients continue to experience symptoms suggestive of CD. This study aimed to assess the long-term outcomes of patients with a negative comprehensive assessment for CD and a negative VCE study.
Aims & Methods
This retrospective cohort study was conducted at a large tertiary inflammatory bowel disease (IBD) center in Israel, serving a broad catchment area and providing VCE services for the entire national population insured by the largest Israeli health maintenance organization. Patients referred for VCE due to suspected CD and inconclusive endoscopy and cross-sectional imaging findings between 2008 and 2017 were included. Two individual capsule endoscopy readers revised all VCE studies. Longitudinal electronic medical records were analyzed to identify subsequent CD or alternative diagnoses. Clinical and laboratory data at the time of the index VCE were also evaluated.
Results
A total of 615 patients were included, of whom 354 (57.5%) were female, with a median age of 36 years (IQR: 27–55). CD was diagnosed in 192 patients (31.2%) based on the index VCE, with a median Lewis score (LS) of 900 (IQR: 450–1350). The remaining 423 patients (68.8%) had normal or minimal findings (LS <135) on VCE. This sub-cohort with negative VCE findings was further followed for a median duration of 8 years (IQR: 5–10; range: 3–12), corresponding to 3,042 patient years of observation. Notably, during follow-up, only 19 patients (4.5%) were diagnosed with CD; the majority based on clinical judgement alone (with no other objective findings), while one patient was diagnosed after a third VCE study. The median time to CD diagnosis was 1.5 years (IQR: 1–3) post-index VCE. Neither clinical symptoms nor basic laboratory results at the time of index VCE predicted CD diagnosis following the negative index VCE.
Conclusion
The incidence of CD diagnosis following a negative VCE study is exceptionally low, with most diagnoses occurring early after the index study. Patients with negative VCE findings may benefit from further diagnostic evaluation to investigate non-CD etiologies for their symptoms.
Disclosure
Iris Dotan: Consultation/advisory board: Abbvie, Arena, Cambridge Healthcare, Celltrion, Celgene/BMS, Ferring, Janssen, MSD, Neopharm, Pfizer, Rafa laboratories, Roche/Genentech, and Takeda; and Speaking/teaching: Abbvie, Celltrion, Celgene/BMS, Ferring, Falk Pharma, Janssen, MSD, Neopharm, Pfizer, Rafa laboratories, Roche/Genentech, Sandoz, and Takeda. Jacob E Ollech: reports institutional research grants from Pfizer. Henit Yanai: Advisory Committee or Review Panels: Takeda, Abbvie, Pfizer, Janssen, BMS, and Eli Lilli; Grant/Research Support: Pfizer; Speaking and Teaching: Abbvie, Pfizer, Takeda, Novartis, and BMS. . Irit Avni-Biron reports honoraria for lectures from AbbVie, Janssen and Takeda, Clinical research specialist, R&D clinical intelligence, Medtronic.
The remaining authors declare no conflicts of interest relevant to this article to disclose