Objective of this study is to determine the prevalence of vitamin B12 deficiency among patients who underwent esophagectomy with GTR. The following specific research questions heve been defined:- What is the prevalence of vitamin B12 deficiency in…
ID
Source
Brief title
Condition
- Vitamin related disorders
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study is the presence of vitamin B12 deficiency, prior
or after esophagectomy with GTR.
Secondary outcome
- The time of onset of a vitamin B12 deficiency durin follow-up.
- Vitamine B12 intake, according to standerdized questionnaires
Background summary
The absorbtion of vitamin B12 in the human body is a fased process. Extracting
B12 out of nutrition and binding it to Intrinsic Factor (IF) are processes that
take place in the stomach. Furthermoere, IF is produced by cells in the stomach
wall. In patients who undergo a esophagectomy with gastric tube reconstruction
(GTR) for esophageal carcinoma, part of the stomach is removed. Also, a
vagotomy is performed, which reduces the production of gastric acid by the
stomach endothelium.
One of the possible adverse effects of the operation is that, on term, patients
can develop a vitamin B12 deficiency. Possible contributing factors for this
are an absolute shortage of IF or perhaps a shortage of gastric acid, which
will lead to a reduced extraction of vitamin B12 out of nutrition.
Earlier studies already showed an increased prevalence of vitamin B12
deficiency in patients who underwent gastric reduction surgery because of
morbid obesity.
Vitamin B12 deficiencies can be symptomatic, in most cases resulting in a
reversible macrocytic anemia, but can also result in irreversible neurological
damage. Nowadays, screening for vitamin B12 deficiency in patients after
esophagectomy with GTR is not common practice.
For this study, we hypothesized that there is a higher prevalence of vitamin
B12 deficiency in patients who underwent esophagectomy with GTR.
Study objective
Objective of this study is to determine the prevalence of vitamin B12
deficiency among patients who underwent esophagectomy with GTR. The following
specific research questions heve been defined:
- What is the prevalence of vitamin B12 deficiency in patients with esophageal
carcinoma prior to esophagectomy?
- What is the prevalence of vitamin B12 deficiency in patients after
esophagectomy with GTR?
- In what period after esophagectomy do patients develop a vitamin B12
deficiency?
- How many of the found deficiencies are symptomatic and thus need immediate
vitamin B12 suppletion?
Study design
Prospective, multi center study.
Patients who are visiting the outpatient clinic in follow-up after undergoing
esophagectomy with GTR or patients placed on the waiting list for this
procedure will be asked to participate in the sudy. If patients decide to
participate, a blood sample will be taken during follow-up in the out-patient
clinic. These samples will be investigated for vitamine B12 deficiency.
Patient who are included in the study before their operation will also donate
three blood samples on the day of admission before operation.
Furthermore, patients will be required to fill in a questionnaire to provide
insight in their diatary intake of vitamin B12.
Patient's participation will stop in case of:
1. A vitamin B12 deficiency is found in the patient.
2. A patient has completed the 5 year follow up after his/her esophagectomy.
In case a vitamin B12 deficiency is found in a patient, he/she will be referred
back to his/her General Practitioner for further treatment.
Study burden and risks
The burden on patients hwo participate in the study will be limited to the
out-patient clinic visits that will be prolonged by 5 minutes per visit, the
time that is needed to take the extra blood samples.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Esophageal carcinome for which esophagectomy with gastric tube reconstruction has been performed or will be performed in the near future.
- Signed Informed Consent.
- Aivailable for follow-up
- Age > 18 years.
Exclusion criteria
- Treatment with any kind of vitamin B12 within the last two months.
- Not able to fill out a questionnaire in Dutch.
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 | NL31089.078.10 |