1. To determine the prevalence of gastric fundic gland polyps in patients undergoing routine upper gastrointestinal endoscopy2. To determine the prevalence of dysplasia in these gastric fundic gland polyps3. To determine the prevalence of gastritis…
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Description of
- the prevalence of gastric fundic gland polyps in this population
- the prevalence of dysplasia in these gastric fundic gland polyps
- the prevalence of gastritis, atrophy, intestinal metaplasia, dysplasia and
Helicobacter pylori
- the serum levels of gastrin, pepsinogen I and II, and anti-Helicobacter
pylori antibodies.
- the results of the questionnaire assessment
Secondary outcome
not applicable
Background summary
Gastric fundic gland polyps are benign gastric polyps that initially were
described in association with Familial Adenomatous Polyposis Coli (FAP), in
which these polyps are found in 40-60% of the patients. Later, these polyps
were recognized to occur sporadically, which is now their most common
presentation. In literature, gastric fundic gland polyps are described in 0.5 -
5 % of upper endoscopy procedures, with varying prevalences depending on the
study population. The prevalence of gastric fundic gland polyps seems to be
increasing, but this could be explained by co-factors such as the use of
different nomenclatures of gastric polyps and the progress in videoendoscopy.
The pathogenesis and etiology of gastric fundic gland polyps is still unclear.
In some studies, a positive association with the use of protonpumpinhibitors
was found, while in other studies this association could not be confirmed.
Several studies have described a negative association between gastric fundic
gland polyps and infection with Helicobacter pylori, but the reason remains
unclear. There seems to be no association between gastric fundic gland polyps
and several types of gastritis.
Unlike in FAP-associated gastric fundic gland polyps, dysplasia is seldomly
found in sporadic gastric fundic gland polyps. The two types of polyps are
histologically similar but genetically different, with mutations in the
APC-gene in the FAP-associated polyps and mutations in the beta-catenin gene in
the sporadic ones.
The occurence of sporadic gastric fundic gland polyps seems to be associated
with an increased incidence of colorectal adenomas. The impact of this finding
is still unclear and it can not be stated yet that a colonoscopy should be
performed when gastric fundic gland polyps are detected.
Study objective
1. To determine the prevalence of gastric fundic gland polyps in patients
undergoing routine upper gastrointestinal endoscopy
2. To determine the prevalence of dysplasia in these gastric fundic gland polyps
3. To determine the prevalence of gastritis, atrophy, intestinal metaplasia,
dysplasia, Helicobacter pylori in patients with and without fundic gland polyps
4. To obtain information about demographic factors, medical history, history of
familial diseases, medication, other intoxications and symptoms in patients
with and without fundic gland polyps
5. To obtain information about the serum levels of gastrin, pepsinogen I and
II, and anti-Helicobacter pylori antibodies in patients with and without fundic
gland polyps.
Study design
All patients undergoing a routine upper gastrointestinal endoscopy will receive
a letter explaining the aim and procedure of the study. An informed consent
form is included in this letter.
All patients with signed informed consent in whom gastric fundic gland polyps
are found, will be included as well as the next two patients in the endoscopy
programme who do not have gastric fundic gland polyps.
During the endoscopy, 2 gastric antrum and 2 gastric corpus biopsies will be
taken as well as 1 or 2 biopsies from the found polyps. In the polyp material,
the histopathological diagnosis will be checked as well as the presence and
grade of dysplasia in these polyps. In the gastric biopsy specimens the
presence and grade of gastritis, atrophy, dysplasia and intestinal metaplasia
will be checked as well as the presence of Helicobacter pylori.
After the endoscopy, the patients will be asked to fill out a questionnaire
with questions regarding symptoms, medication, intoxications, medical history
and history of familial diseases. In addition, a venous blood sample will be
obtained in which gastrine and pepsinogen I and II will be measured, as well as
anti-Helicobacter pylori antibodies.
Study burden and risks
There are no risks associated with participation in this study, neither will
patients benefit from it. The burden of participation consists of a lengthening
of the upper gastrointestinal endoscopy with at most 2 minutes, the
questionnaire assessment and the obtaining of the venous blood sample.
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
age > or = 18 years
signed informed consent
cases: endoscopical presence of gastric fundic gland polyps
controls: no endoscopical presence of gastric fundic gland polyps
Exclusion criteria
coagulation disorder
use of warfarin or other anti-coagulant medication if uncorrected at the time of endoscopy
liver cirrhosis
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 | NL13536.078.06 |