Primary aim of this study is to validate easy and reliable tests to detect EPI in patients after gastrointestinal surgery. The 72-hour faecal fat quantification (gold standard), will be compared with a shortened version of 24-hours, the FET and 13C-…
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is diagnostic accuracy of easy diagnostic test(s) and
the presence of steatorrhea-related symptoms to diagnose EPI, compared to the
72-hour faecal fat quantification.
Secondary outcome
- presence of micronutrient deficiencies
- incidence of EPI in this patient group
- evaluate whether the occurrence of EPI can be predicted based of specific
signs and symptoms
- evaluate the effect of changes in therapy based on the results of the
diagnostic tests included in this study
- evaluate the effect of EPI on overall quality of life in postoperative
patients
Background summary
In patients with cancer of the periampullary region, weight loss is a serious
problem, affecting 80% already at diagnosis. For this, both primary and
secondary tumour effects are responsible. Exocrine pancreatic insufficiency
(EPI) is a secondary tumour effect, in which the pancreas is unable to deliver
sufficient pancreatic enzymes into the small intestinal lumen to digest food.
It may occur due to gland atrophy, obstruction of the pancreatic duct,
anatomical changes or removal of functional pancreatic tissue after surgery. A
shortage of pancreatic enzymes causes maldigestion, primarily of fat, leading
to steatorrhea-related symptoms, weight loss, malnutrition, and an impaired
quality of life. This not only affects patients with cancer of the
periampullary region, it can also affect patients who underwent
gastrointestinal surgery for cancer, including a pancreatoduodenectomy (PD),
gastrectomy, or esophagectomy. To prevent these symptoms patients should be
treated with an adequate dosage of pancreatic enzymes. The gold standard to
diagnose EPI is the 72-hour faecal fat quantification. This is a time-consuming
and burdensome test, as patients need to follow a strict diet of 80-100 grams
of fat during 5 days and collect all stool during the last 72 hours. The Faecal
Elastase-1 Test (FET), is currently mostly used in clinical practice, as only a
small stool sample is needed without any dietary restrictions. Previous
studies, including a pilot study from the Amsterdam University Medical Center,
suggest that the FET is possibly less accurate to detect EPI in patients after
gastrointestinal surgery. Aim of this study is to investigate the value of
several diagnostic tests, including a shortened version of the current gold
standard test, to detect EPI in these patients.
Study objective
Primary aim of this study is to validate easy and reliable tests to detect EPI
in patients after gastrointestinal surgery. The 72-hour faecal fat
quantification (gold standard), will be compared with a shortened version of
24-hours, the FET and 13C-mixed triglyceride (13C-MTG) breath test. These
parameters will also be compared with the presence of steatorrhea-related
symptoms. Secondary endpoints are presence of micronutrient deficiencies,
incidence of EPI in this patient group and to evaluate whether the occurrence
of EPI can be predicted based of specific signs and symptoms.
Study design
Prospective observational cohort study
Study burden and risks
In current practice, there is no unequivocal protocol to supplementation of
pancreatic enzymes after gastrointestinal surgery. As a result patients may be
undertreated or over treated, often without objective confirmation of exocrine
insufficiency trough a valid diagnostic test. The benefit of participating in
this study is that patients will undergo diagnostic tests to objectively
determine the presence of EPI. As a result, all patients with confirmed EPI
will be treated with pancreatic enzymes. Burden of this study is expected to be
low, as patients will undergo several diagnostic tests, most of them part of
standard clinical care. Therefore no serious events are foreseen for patients
joining this study.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1) Age * 18 years;
2) Written informed consent;
3) Understanding of the Dutch language;
4) Willing and capable of following the instructions for this study;
5) Patients need to be able to achieve a minimal daily dietary fat intake of *
60 grams.
Exclusion criteria
1) Any known gastrointestinal disease or major gastrointestinal surgery (apart
from a PD, esophagectomy, gastrectomy) that could potentially affect the
intestinal absorption or metabolism of fat (e.g. short bowel, irritable bowel
disease, cystic fibrosis, chronic pancreatitis among others).
2) Gastroparesis of any aetiology (not applicable for group III and IV) .
3) Serious concomitant systemic disorders that would compromise the safety of
the patient or his/her ability to complete the study, at the discretion of the
treating physician.
4) Patients who are unable to cease anti-diarrheal medication or laxatives,
based on the physician*s experience.
5) Patients who are suspected not to be reliable in participating in this
study, based on the physician*s experience.
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 | NL68432.029.19 |