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Comparaison de la Chromo Endoscopie Virtuelle FICE (Fujinon Intelligent Chromoendoscopy) Avec la Coloscopie Conventionnelle Dans la détection de la Dysplasie Chez Patients Porteurs de Recto Colite ulcéro hémorragique (RCH).

18 Years
Open (Enrolling)
Ulcerative Colitis

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Trial Information

Comparaison de la Chromo Endoscopie Virtuelle FICE (Fujinon Intelligent Chromoendoscopy) Avec la Coloscopie Conventionnelle Dans la détection de la Dysplasie Chez Patients Porteurs de Recto Colite ulcéro hémorragique (RCH).

Patients will undergo two colonoscopies each, with an interval of three months between
procedures. This minimum time interval is chosen in order to allow for the healing of the
mucosa on sampled areas and thus prevent recognition of biopsy sites. The first procedure
will be randomly allocated to be either conventional white light endoscopy coupled with
targeted and random biopsies or high-resolution endoscopy with FICE system and
magnification. Randomisation will be achieved prior to the first endoscopy by means of
sealed envelopes. In each recruitment centre, one of the two endoscopists with experience in
endoscopic surveillance and treatment of ulcerative colitis will be assigned to carry out
the first procedure. The second procedure will automatically be scheduled with the second
endoscopist, who will be blinded as to the clinical and histological findings of the first

The two participating centres are already endowed with identical endoscopic equipment. All
examinations will be performed using the same high resolution endoscope (EC-590 ZW, Fujinon
Inc., Daitama, Japan). The zoom function on the device will only be used during the FICE
procedures. The system is equipped with the EPX 4400 processor (Fujinon Inc., Japan) that
enables the CVC technology. This digital processing system can switch between conventional
imaging and CVC imaging at any time during the procedure by means of a simple pushbutton on
the endoscope. The system has up to ten (# 10) settings designed to select the most suitable
wavelengths. In this study the CVC procedure will be performed using setting number three (#

The colonoscopy protocol will be the same in both participating centres. All patients will
undergo a bowel preparation consisting in the intake of four litres of hypertonic
polyethylene glycol solution. The procedures will be performed under conscious sedation
using propofol. The caecum will be reached in white light endoscopy in all cases. Cecal
intubation will be confirmed by identification of the ileocecal valve and appendiceal
orifice. Upon extubation, 20 mg of butyl scopolamine will be given intravenously, barring
any contraindication, to reduce colonic motility and facilitate the examination of the
colon. When performing the FICE procedure, the imaging mode will be switched to CVC at the
caecum and will then be used throughout withdrawal. The endoscopist will classify the degree
of inflammation in each segment of the colon on a scale and give the Mayo Clinic score
(proctosigmoiditis - left-sided colitis - Pan Colitis). The quality of the bowel preparation
will be noted. During the extubation phase, washing of the colon and aspiration of waste
will be accomplished in an optimal way to maximise the detection capabilities of each

The biopsy protocol is meant to reflect observed mucosal abnormalities and, in the case of
conventional colonoscopy, it will be supplemented by random samples taken every 10 cm of the
colon. A standard biopsy forceps will be used (Radial Jaw 4, Boston Scientific Inc., USA).
To reduce the risk of sampling error, a minimum of two biopsies for each suspicious lesion
will be performed. The number of lesions suspect of neoplasia will be noted and targeted by
each procedure. In the case of high-resolution FICE colonoscopy, an analysis of the surface
pattern will be performed for each targeted lesion according to the pit pattern
classification. Suspicious FICE lesions will be defined as having a polyploidy, flat or
irregular mucosal structure with Kudo pit pattern III - V, unusual ulcers, strictures or
areas with increased and disrupted vascular intensity revealed by dark
coloration/discoloration and confirmed with magnification (annexe 9). In conventional
endoscopy without FICE, suspicious lesions will be defined as polypoid or irregular mucosa,
and unusual ulcers or strictures. During the conventional white light endoscopy (but not
during FICE) additional four-quadrant random biopsies will be taken every 10 cm of colon and
placed in a specimen container of formalin. Targeted biopsy samples will be sent separately
for analysis.

The histopathological evaluation will be performed twice, by two different pathologists, at
each participating centre. The pathologists were recruited according to their expertise in
digestive histology. For the purposes of this study, they will be blinded to the assessment
of the endoscopist when analysing biopsy samples. The inflammation activity level of each
specimen will be ranked into the following categories: no inflammation, mild to moderate
inflammation or severe inflammation. Dysplasia will be classified according to the new
Vienna classification 21. Lesions classified as "indefinite for neoplasia" with no
differentiation between adenoma and colitis-associated dysplasia in biopsy material will be
not considered as neoplastic. The final histopathology findings will then be compared with
the endoscopic assessment with regards to the presence of intraepithelial neoplasia and
colorectal cancer.

Inclusion Criteria:

- Clinically and histologically verified UC

- Disease duration ≥ 8 years

- A Mayo score ≤ 8 with an endoscopic sub score ≤ 2

- CPAM affiliation

- Able to give written informed consent to participate in the study

Exclusion Criteria:

- Known intraepithelial neoplasia or colorectal cancer or any other active

- Previous colo-rectal surgery

- Non-treatable coagulopathy or hemostatic dysfunction (prothrombin index < 50% of
control or/and partial thromboplastin time > 50 seconds and/or thrombopenia < 60000 /

- Pregnancy

- Inability to give informed consent

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy)

Outcome Time Frame:

3 months between FICE and Conventional white light colonoscopy

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Departement d'Endoscopie digestive, CHU de Nice


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

October 2008

Completion Date:

October 2010

Related Keywords:

  • Ulcerative Colitis
  • patient with long-standing UC
  • Colitis
  • Colitis, Ulcerative
  • Ulcer