Abstract

1
Abstract

• Assessment of endoscopic activity is of growing
  importance in Crohns disease (CD) both in
  clinical practice and in therapeutic trials. The
  Rutgeertss score (RS) is considered as the
  standard to evaluate endoscopic recurrence after
  surgery. The Crohn's Disease Endoscopic Index of
  Severity (CDEIS) is a prospectively developed and
  validated score widely used in CD trials, but not
  in this specific setting. The aim of this
  prospective study was to compare the two scores
  and to evaluate their reproducibility in
  assessing postoperative (po) endoscopic
  recurrence.
• Methods. Endoscopic data of 72 patients
  participating in two multicentre randomized
  clinical trials for the prevention of endoscopic
  recurrence after curative ileocolonic resection
  were used for the purpose of this study. During
  each procedure, endoscopic recurrence was graded
  using the RS ranging from i0 (no lesion) to i4,
  and the po-CDEIS was calculated for two segments
  (ileum and anastomosis). Endoscopies were
  recorded on videos in 39 patients, and each
  record was re-evaluated by 4 of 13 independent
  blinded observers using a balanced incomplete
  block randomization. The reproducibility of the
  two scores was calculated using the kappa
  estimates for the RS (agreement was considered as
  poor, moderate, good and excellent for kappa
  coefficients lt0.4, 0.4-0.6, 0.6-0.8 and gt0.8,
  respectively), and the intraclass correlation
  coefficient for the po-CDEIS.
• Results. In the whole population (n72), a
  significant correlation was found between the RS
  grade and the median po-CDEIS score (plt0.001),
  but with overlap, especially for the i2 and i3
  grades. In the subset of 39 patients used to
  assess the interobserver reproducibility, the
  kappa estimates were 0.51 (95CI 0.38-0.64),
  0.16 (0.02-0.20), 0.40 (0.30-0.50), 0.19
  (0.03-0.35), and 0.72 (0.61-0.83) for the i0, i1,
  i2, i3 and i4 grades of the RS, respectively. The
  kappa estimate was 0.57 (0.43-0.71) for the RS
  globally, 0.45 (0.23-0.66) for a scoregti1, and
  0.64 (0.44-0.83) for a score gti2. The intraclass
  correlation coefficient for the po-CDEIS was 0.52
  (95CI 0.36-0.67 plt0.001).
• Conclusion. The Rutgeerts score and the po-CDEIS
  correlate for assessment of endoscopic
  postoperative recurrence but the reproducibility
  of the two scores is moderate. Definition of
  endoscopic recurrence based on the sole use of a
  cutoff value is questionable.

2
Introduction

• Endoscopic recurrence is largely used as endpoint
  in clinical trials for postoperative prevention
  in Crohns disease. To be used in this setting,
  endoscopic score should be simple, reproducible
  and modified by therapies.
• The Rutgeerts score (RS) is considered as the
  standard because this five-scale score has been
  shown to be correlated with the delay of clinical
  recurrence, but it has never been strictly
  validated.
• The CDEIS (Crohns Disease Endoscopic Index of
  Severity) is a well validated score in
  ileocolonic active disease, but has never been
  evaluated for postoperative endoscopic
  recurrence.
• Aims of the study
• To compare the Rutgeerts score and the
  postoperative CDEIS (po-CDEIS)
• To study reproducibility of the two scores
• To study factors predictive of endoscopic
  recurrence.

3
Methods

• Multicentre prospective study.
• Endoscopic data coming from two clinical trials
  for prevention of endoscopic recurrence after
  ileocolonic resection.
• Inclusion criteria
• right ileocolectomy
• curative resection (resection of all macroscopic
  lesions)
• 4 types of evaluation were consigned after each
  colonoscopy performed 6-24 months after surgery
  using a standardized form including
• Qualitative global evaluation of severity EGQV
  (from 0 no lesion to 4, severe)
• Quantitative global evaluation Visual Analogic
  Scale (10 cm)
• Rutgeerts score RS (i,0 à i,4)
• po-CDEIS calculated for ileum and anastomosis
  taking into account presence of superficial and
  of deep lesions, surface of ulcerations and
  surface of lesions.
• Video recording for study of reproducibility.

4
Results-1

• Study population
• N 72
• Age (years) 31 (27-35)
• Female 39 (54)
• Smokers 20 (28)
• Duration (months) 28 (7-88)
• Prior surgery 13 (18)
• Penetrating disease 33 (46)
• Disease locationsmall bowel 41
  (58small bowel colon 28 (39)colon
  2 (3)

Médiane (percentiles)
2Ileoscopy not done (n3) Ileoileal anastomosis
(n1) Incomplete form (n1)
1GETAID 2001-1 azathioprine vs mesalazine and
GETAID 2001-2 Lactobacillus LA1 vs placebo
5
Results-2 Elementary lesions
ILEON
ANASTOMOSIS
Grade 1 ulcerations ?5 or ?50
circumferencepassable stenosislocalized
erythema or swollen mucosapseudopolyps or healed
ulcerations ?5

• Ulpro deep ulcerations
• Ulsup superficial ulcerations
• Ulpun punctiform ulcerations
• Stul ulcerated stenosis
• Stnul non ulcerated stenosis
• Eryfr frank erythema
• Mbsfl swollen mucosa
• Ppoly pseudopolyp
• Ciulc healed ulceration

6
Results-3 po-CDEIS correlation study
Plt0,001

• Kruskal-Wallis test

Plt0,001
Rutgeerts score
Kruskal-Wallis test
Spearmans correlation test
Median (percentiles) statistic test
7
Results-4 Rutgeertss score correlation study
n16
n29
n8
n5
n14
10
Plt0,001
8
Quantitative evaluation
6
Qualitative evaluation
4
2
0
0
1
2
3
4
Rutgeertss score
Rutgeertss score
Test de Kruskal-Wallis
8
Results-5 Reproducibility
Elementary lesions
ileon
kappa
anastomosis
0.5
0.4
0.3
0.2
0.1
0
-0.1
-0.2
-0.3
ulpro
ulsup
ulpun
stul
stnul
eryfr
mbsfl
ppoly
ciulc
Rutgeertss score
kappa
good
po-CDEIS
moderate
Intraclass correlation coefficient
0.52 (95CI 0.36-0.67)
poor
9
Results-6 Factors predictive for postoperative
endoscopic recurrence (multivariate analysis)
Disease behavior
Tobacco


50
50
45
45
40
40
35
35
30
30
25
25
non penetrating
non smokers
20
20
smokers
penetrating
15
15
10
10
5
5
0
0
0
1
2
3
4
0
1
2
3
4
Rutgeertss score
Rutgeertss score
Odds ratio, CI 95
10
Conclusion

• Rutgeertss score and po-CDEIS are well
  correlated.
• Reproducibility of the two scores is moderate.
• The choice of a cutoff value to define endoscopic
  recurrence is questionable. The use of a
  quantitative score like the po-CDEIS in clinical
  trials should be preferred.
• Our study confirms that smoking and penetrating
  behavior are independant factors predictive of
  severe endoscopic recurrence.