A prospective evaluation of pancreatic cyst surveillance, based on the consensus statement, formulated by the European study group on cystic tumours of the pancreas

Recruiting

Conditions: cystic tumor of the pancreas
Pancreatic cyst
10017991

Registration Number: NL-OMON55977

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 2500

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)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are:<br /><br>1. Number of cysts reaching an indication for resection.<br /><br>2. Number of patients, diagnosed with a malignant cyst (either high-grade<br /><br>dysplasia or carcinoma).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are to evaluate:<br /><br>1. The course of patients with an indication for cyst resection (surgery,<br /><br>outcome, and recurrence).<br /><br>2. Cyst evolution, in terms of development of symptoms, cyst growth, nodules,<br /><br>and secondary duct dilation.<br /><br>3. The perceived burden of surveillance for participating subjects.<br /><br>4. Potential risk factors for malignancy.<br /><br><br /><br>and<br /><br>5. To build a micro-simulation screening analysis (MISCAN) model, based on the<br /><br>outcome data of this study, in order to determine the optimal surveillance<br /><br>strategy for pancreatic cysts. </p><br>