The overall objective is to assess the effectiveness of treating patients with corticosteroids prior to surveillance in order to diminish the pitfall of active inflammation.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study outcome is presence of histological inflammation of the mucosa
Secondary outcome
Secondary study paramteres are presence of other pathologic findings during
endoscopy and/or in the pathology report and the management of these
pathological findings. Patient characteristics that will furthermore be used in
the analysis are demographic factors, like age and sex and disease
characteristics like disease duration, activity and course as well as
medication use.
Background summary
Patients with inflammatory bowel disease have a sufficient increased risk of
developing colorectal carcinoma. Therefore surveillance for detecting early
dysplasia using colonoscopy, could be performed by screening patients with
colitis for neoplasia 8-10 yr after disease onset. However, there are some
limits to this surveillance. One of the pittfals is active inflammation at time
of surveillance. The specificity of dysplasia as a marker of precancer or
cancer is controversial. Lesser degrees of inflammation are difficult to
distinguish histologically from regenerative changes as a result of
inflammation. Therefore surveillance cannot be performed when active mucosal
inflammation is present. In that case patients first have to get treatment in
order to get mucosal healing before they can get another surveillance
colonoscopy. This is a burden to the patients and a stress to the endoscopy
centers.
Study objective
The overall objective is to assess the effectiveness of treating patients with
corticosteroids prior to surveillance in order to diminish the pitfall of
active inflammation.
Study design
Randomized clinical trial
Intervention
Patients will be randomized to either two weeks daily 20 mg Prednisone and
Calcium vit. D prior to surveillance colonoscopy or no treatment at all.
Patients in the treatment arm will be asked to fill out a short questionnaire
in order to asses therapy adherence.
Study burden and risks
Use of prednisone is in general not associated with side effects, only in case
of high dosis of longterm use. However, there are some possible side effects
like fluid problems (e.g. fluid retention), psychological problems (e.g. mood
swings), and skin reactions. In order to prevent osteoporosis due to longterm
use of corticosteroids calcium tablets will be prescribed to the patients.
There is a potential benefit associated with participation in this study. The
use of Prednison is likely to diminish the possible active mucosal inflammation
which will result in mucosal healing and probably a better assesment of the
biopsy material in order to detect (pre)cancer. This will prevent patients from
needing a second surveillance colonoscopy due to active mucosal inflammation.
s-Gravendijkwal 230, kamer Ba 393
3015 CE Rotterdam
NL
s-Gravendijkwal 230, kamer Ba 393
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed with either ulcerative colitis or Crohn???s disease by established criteria scheduled for surveillance colonoscopy between April 1, 2008 and March 31, 2009 in the Erasmus Medical Center will be entered into this study.
Exclusion criteria
Exclusion criteria are: diabetes, pregnancy, hypertension and known adverse reactions on earlier use of Prednisone.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-001427-61-NL |
| CCMO | NL21825.078.08 |