With this study we want to investigate the possible correlation between pre malignant abnormalities in the colon and inflamation of the colonic mucosa in patients with long lasting (more than 8 years) diverticular disease.Patients included will…
ID
Source
Brief title
Condition
- Diverticular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study aims to evaluate the possible interaction between chronic
inflammation and precancerous lesions in diverticular disease.
Secondary outcome
Secondary Objectives:
Semi-quantitative scoring for
* Dysplasia
o No dysplasie
o Indefinite for dysplasia
o Low grade dysplasia
o High grade dysplasia
* Inflammation (active and chronic)
o 0 = normal looking (round nuclei) infiltrate of the lamina propria, with a
cell distribution gradient towards basal
o 1= loss of gradient (because more cells are located basely)
o 2 = loss of gradient and presence of neutrophil granulocytes
o 3 = loss of gradient and ulceration in combination with/or presence of crypt
abscesses
* Apoptosis
o 0 = 0 or 1 apoptotic cell per biopsy
o 1 = more than 1 apoptotic cell per biopsy
* Fibrosis
o 0 = no fibrosis
o 1 = presence of fibroses
Using immunohistochemical staining, cases indefinite for dysplasia will be
evaluated by
* MIB1
* P53
Background summary
The available literature regading the influence of chronic diverticular disease
on the colonmucosa is not ambigious. These are some studies stating to have
found increased rates of (pre) malignant abnormalies in patietns with chronic
diverticular disease.
Chronic inflammation can seriously effect the quality of the colonic mucosa.
Long term inlfammation in the colon is known to influence normal cellular
structure in a negative way. Which coul ultiimately lead to the presence of
high grade dysplasia and colorectal cancer.
The possible sequelea of chronic inflammation in patients with inflammatoire
bowel disease are well recorded. As patients with Crohns disease and/or Colitis
Ulcerosa are screened for the presence of colorectal carcinoma. The guidelines
state that specialists should commence screening an average 8 years after
diagnosis has been made, depending on disease activity.
Study objective
With this study we want to investigate the possible correlation between pre
malignant abnormalities in the colon and inflamation of the colonic mucosa in
patients with long lasting (more than 8 years) diverticular disease.
Patients included will undergo sigmoidoscopy or colonoscopy and bioptes will be
taken from three portions of the end of the colon. These biopties will be
scored by two independents skilled patholog
We hypothesise to find a positive correlation between severity of mucosa
inflammation and grade of colonic mucosa dysplasia. When such a correlation is
found more research regarding this subject is neccesary.
Study design
After H&E staining, semi-quantitative scoring for dysplasia, inflammation
(active and chronic), apoptosis and fibrosis is performed. Cases indefinite for
dysplasia will be evaluated by MIB1 and p53
.
Study burden and risks
Very slightly increased risk of a perforation of the colon.
In patients with long lasting diverticulitis an increased chance of developing
(pre)cancerous lesions could be present. Histological evaluation of tissue from
a site in chronic inflammation could show us if the risk of malignant
transformation is increased in these patients.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Informed consent (IC)
Patients undergoing a colonoscopy/sigmoidoscopy
Exclusion criteria
Refusal of participation
Inflammatory bowel disease
A medical history of colorectal cancer or pre-maligmant polyp(s)
Previous surgery of the colon
History of familial colon cancer
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 |
|---|---|
| CCMO | NL44351.029.13 |