First, to establish the yield of the currently propagated pancreatic cyst surveillance program, and second, to identify possible alternative surveillance strategies, which might be more (cost) effective.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are:
1. Number of cysts reaching an indication for resection.
2. Number of patients, diagnosed with a malignant cyst (either high-grade
dysplasia or carcinoma).
Secondary outcome
Secondary endpoints are to evaluate:
1. The course of patients with an indication for cyst resection (surgery,
outcome, and recurrence).
2. Cyst evolution, in terms of development of symptoms, cyst growth, nodules,
and secondary duct dilation.
3. The perceived burden of surveillance for participating subjects.
4. Potential risk factors for malignancy.
and
5. To build a micro-simulation screening analysis (MISCAN) model, based on the
outcome data of this study, in order to determine the optimal surveillance
strategy for pancreatic cysts.
Background summary
Asymptomatic pancreatic cysts are a common finding in this time of elaborate
imaging. The malignant potential of these cysts is probably small, but data
regarding risks are not available. Generally, an intensive surveillance
strategy is chosen, driven out of fear to miss one of the most deadly cancers,
and based on international recommendations. This strategy may be justified for
some individuals, to timely detect malignant progression, but the majority of
cysts will never progress. Consequently, most patients are undergoing lifelong
redundant (and costly) investigations.
Study objective
First, to establish the yield of the currently propagated pancreatic cyst
surveillance program, and second, to identify possible alternative surveillance
strategies, which might be more (cost) effective.
Study design
An international multicenter observational cohort study that will run for 15
years. The first analysis will take place in 2018. Results will be available in
2020.
Study burden and risks
There will be no risk for patients participating in this study. The follow-up
schedule is in accordance with common practice and recently published treatment
recommendations. The burden for participating patients will be to fill out a
questionnaire after each follow-up visit. In addition, two to three extra blood
samples will be obtained, during the vena-puncture procedure that is part of
the follow-up schedule. At last, pancreatic juice will be collected in patients
with worrisome features after injection of secretine, which does not harbor any
significant risks, yet prolongs procedure time with 5-10 minutes.
A part of the participants with a low-risk cyst will be participating in a
one-time focus group or interview. All the participants with a low-risk cyst
will get a one-time additional questionnaire.
A potential benefit of study participation will be a better compliance to the
surveillance program.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Individuals with a pancreatic cyst (either newly or previously diagnosed)
• Cyst surveillance is warranted, according to the treating physician
• Age >18
• Informed consent
Exclusion criteria
• History of chronic pancreatitis
• Suspected pseudocyst
• Suspected serous cystadenoma
• Von Hippel-Lindau disease
• Limited life expectancy (< 2 years)
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 | NL45556.078.13 |