Early detecting of dysplasia and adenocarcinoma in patients with long excisting crohn's disease.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determin the frequency of small bowel dysplasia and adenoma carcinoma by
endoscopy with biopsies in a population of Crohn's disease patients with a high
risk of dysplasia and adenomacacinoma due to a disease history of more than ten
years.
Secondary outcome
1.2.1. Evaluation of the feasibility of endoscopic surveillance defined as
success rate of reaching the small intestine lesions endoscopicly and to
collect biopsies
1.2.2. Evaluation of the importance of indigo carmine colouring for diagnosis
of dysplasia and cancer of the small intestine
1.2.3. Determination of the factors associated with the presence of dysplasia
and cancer.
1.2.4. Evaluation of the complication caused by the endoscopic procedures and
biopsies
Background summary
Adenoma of the small intestine is rare and represents 2% of the digestive
cancers. The disease appears more often in patients with crohn*s diseaese.
Recent meta analysis of 9642 patients showed a relative risk of adenoma
carcinoma of the small intestine of 28.4 compared with the regular population.
The risk has increased in patients with exclusive small intestine involvement
(relative risk 58.5).
The average survival time after diagnosis is 28 months. One of the reasons for
this bad prognosis is the late stage in which the diagnosis is made. Often the
diagnosis is made after resection, because the clinical symptoms and radiology
findings of a adenoma carcinoma of the small intestine are similar to
inflammatory stenosis.
In analogy with the surveillance strategy for dysplasia in patients with
ulcerative colitis and crohn*s disease of the colon, a screening of the small
intestine in long existing crohn*s disease should be very effective to locate
the disease.
Study objective
Early detecting of dysplasia and adenocarcinoma in patients with long excisting
crohn's disease.
Study design
Study with an international prospective cohorte.
Study burden and risks
There is no extra burden of risk for patients participating in this study. When
a patient decides not to participate he/she will also undergo a endoscopy with
biopsies as part of their regular patient care.
meibergdreef 9
Amsterdam 1105 AZ
NL
meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- M. Crohn of the jejunum and/or ileum with or without other involved areas of the gastrointestinal system
- Lesions of the small intestine which exist for at least 10 years (patient with a ileocolonic anastomosis with isolated ileal lesions for more than 10 years may be included, but this sub group may only be 30% of the included patients).
- Crohn lesions accessible by endoscopy
- CT scan or MRI of the small intestine in the last 12 months to locate the lesions.
- Signed informed consent
Exclusion criteria
- History of dysplasia or cancer of the small intestine
- Contra-indication for an endoscopy
- Not willing to participate
- Pregnancy
- Participating in an other clinical trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01180452 |
| CCMO | NL40151.018.12 |