Complicated Crohn's Disease Clinical Trial
Official title:
Use of Fecal Calprotectin as a Surrogate Marker for Macroscopic Recurrence of Disease in Patients With Crohn's Disease After Intestinal Resection
our primary objective is to correlate fecal calprotectin with currently used Crohn's disease endoscopic disease activity scores used for predicting endoscopic recurrence. Our secondary objectives will be to determine a cutoff for early macroscopic recurrence of disease based on surveillance colonoscopies , and to compare this with other surrogate markers .
Fecal calprotectin is a non invasive marker of intestinal inflammation. It is highly
sensitive for the detection of active Crohn's disease (13) and mucosal healing (14). Levels
higher than 250 mg/L are associated with relapse, and levels < 50 usually with remission.
Mucosal healing was noted in patients with calprotectin levels less < 130 mg/L, and a mean
level < 30 mg/L (13,14) .It is therefore an excellent candidate for a simple clinically
available surrogate marker for endoscopic recurrence after intestinal resection in Crohn's
disease. In the current study, our primary objective is to correlate fecal calprotectin with
currently used Crohn's disease endoscopic disease activity scores used for predicting
endoscopic recurrence. Our secondary objectives will be to determine a cutoff for early
macroscopic recurrence of disease based on surveillance colonoscopies , and to compare this
with other surrogate markers .
Methods This will be a prospective non-interventional observational study, performed at the
Sourasky Medical center in Tel Aviv, over two years.
Patients with confirmed Crohn's disease undergoing intestinal resection for complicated
Crohn's disease - will be followed for one year, and undergo a follow- up colonoscopy
between 6-9 months after surgery. Patients will be seen at enrollment and follow-up visits,
3,6,9& 12 months after surgery. At enrollment, sites of disease, age of onset, smoking
history and previous medication use will be registered, as well as presence of strictures
and fistula, or previous surgery. At all visits, patients will be questioned regarding
disease symptoms, smoking, and medication use. During each of the follow-up visits, patients
will be examined, weighed, and have a disease activity index recorded. At all follow-up
visits, they will undergo the following tests; CBC, ESR, CRP, and fecal calprotectin. Sera
will be stored for antibodies such as ASCA or anti glycan antibodies.
During colonoscopy, disease recurrence will be evaluated by two scores, the Rutgeerts score
and the CDEIS score, both containing 4 grades. Recurrence will be assessed by histological
findings as well.
End points For the primary outcome, we will check if calprotecin levels are correlated with
endoscopic scores. We will also evaluate cutoffs of calprotectin that are correlated with
grade 3 or 4 Rutgeerts or CDEIS.
Other secondary endpoints will include:
Correlation between calprotectin and early clinical relapse (within one year) Correlation
between calprotectin and histologic relapse (within one year) Correlation between anti
glycan antibodies and early clinical relapse (within one year) Correlation between CDEIS and
antiglycan antibodies
;
Observational Model: Case-Only, Time Perspective: Prospective