The aim of this study is: 1) to determine the burden of ERCP in patients undergoing ERCP (descriptive study) and 2) to determine patients preferences for treatment strategy of CBDS (Discrete Choice Experiments).
ID
Source
Brief title
Condition
- Bile duct disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part I:
Burden of ERCP
Part II:
Patient preferences for CBDS treatment
Secondary outcome
Part I:
Physical symptoms (throat ache, nausea etc), quality of life and functional
results (Bilirubine, ALAT, ASAT etc).
Part II:
The relevance and importance of determinants of patient preferences for CBDS
treatment (characteristics of the treatment options, and respondent
characteristics)
Background summary
At the Erasmus MC Rotterdam, yearly 750 ERCPs and at the University Medical
Center Utrecht, yearly 350 ERCPs are performed. An ERCP is an invasive
procedure that is burdensome to patients and is associated with anxiety and
discomfort. In addition, patients may have recurrent symptoms, requiring a
reintervention, which may increase the burden of ERCP.
Common bile duct stones (CBDS) are the most common indication for ERCP.
Currently, two endoscopic treatment strategies are available for the removal of
CBDS. First, an endoscopic sphincterotomy (ES) followed by a cholecystectomy
can be performed for the treatment of CBDS. Second, stone extraction by ERCP
can be followed by a wait-and-see policy.
Currently, the patient preference for CBDS treatment is unknown. In addition,
nothing is known on the experienced health status. Do the advantages of an
invasive ERCP or CBDS treatment compensate for its disadvantages? The treatment
for CBDS seems to depend on the preference of the physician. Knowledge on the
burden of ERCP and patient preferences for CBDS treatment may contribute to the
improvement of counseling patients undergoing ERCP and/or treatment for CBDS.
Study objective
The aim of this study is: 1) to determine the burden of ERCP in patients
undergoing ERCP (descriptive study) and 2) to determine patients preferences
for treatment strategy of CBDS (Discrete Choice Experiments).
Study design
Multicenter, prospective observational study with 7-day follow-up, subdivided
in part I (burden of ERCP), part II (patient preferences for treatment
modalities of CBDS).
Study burden and risks
Part I:
Patients will fill in a burden of ERCP quationnaire on day 1. Physical symptoms
will be measured during 7 day follow-up after ERCP, by means of (telephone)
interviews on day 0, 1 and 7.
Filling in all questionnaires during the 7-day follow up will take 20 minutes
of time.
Part II:
Patients will fill in a questionnaire on preferences for CBDS treatment on day
0. Filling in this questionnaire will take 15 minutes.
's Gravendijkwal 230
3015 CE Rotterdam
Nederland
's Gravendijkwal 230
3015 CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Part I: Burden of ERCP
a) Patient is undergoing an ERCP at the Erasmus MC-University Medical Center Rotterdam or University Medical Center Utrecht
b) Informed consent
Part II: Patient preference for common bile duct stone (CBDS) treatment
a) Patient is undergoing an ERCP for CBDS
b) Patient is referred from the Erasmus MC-University Medical Center Rotterdam or University Medical Center Utrecht
c) Patient participates in Part I
d) Informed consent
Exclusion criteria
Part I: Burden of ERCP
a) Patient is referred from another hospital
b) Not being able to fill out the questionnaire
Part II: Patient preference for CBDS treatment
a) Patient is referred from another hospital
b) Not able to fill in the questionnaire
c) Comorbid disease (e.g. malignancy, terminal illness, WHO performance score of 4)
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 | NL17558.078.07 |