Feasibility of Molecular Biology in Pancreatic Cyst Tumors (CYST-GEN)

Hospital Saint Joseph

Status: Active, not recruiting

Conditions: Serous Cystadenoma; Pancreatic Cyst; IPMN; Mucinous Cystadenoma; Pancreas Cyst

Treatments: Genetic: Molecular biology analysis of pancreatic intra-cyst fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT03305146

2016-A01399-42

Details and patient eligibility

About

The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.

The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.

Full description

Multicenter study to determinate the feasibility of intra-cystic fluid DNA molecular analysis in patients with suspected cystic tumours of pancreas in whom EUS FNA is clinically indicated.

Morphological criteria obtained by MRI and computerised tomography (tumor characterization (size, metastases presence, dilatation of bile ducts), etiologic diagnosis, serious symptoms), biological exams (biomarkers), cytological analysis will lead to a diagnosis and a treatment.

The goal of this study is to compare this standard diagnostic modalities to diagnosis obtained by intra-cystic fluid DNA molecular analysis.

Is the DNA molecular analysis improve the diagnosis accuracy.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient older than 18 years of age, male or female
• Cystic tumor of the pancreas requiring a puncture under endoscopic control to determine the etiologic diagnosis and gravity.

Exclusion criteria

• Doubts regarding the etiological diagnosis of the pancreatic cyst
• Contraindications for the realization of a high digestive endoscopy
• Haemorrhagic disorder, haemostasis and coagulation disorder (TP <60%, TCa> 40 sec and platelets <60000 / mm3).
• AVK, AOD and AAP cannot be stopped

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 1 patient group

single arm

Experimental group

Description:

For inoperable patients with indeterminate cystic lesions of the pancreas,a EUS FNA will be performed and molecular biology analysis of pancreatic intra-cyst fluid collected by EUS FNA will be performed. For operable patients, after the pancreatic surgery, molecular biology analysis of extemporaneous pancreatic tissue specimen biopsy will be conducted.

Treatment:

Genetic: Molecular biology analysis of pancreatic intra-cyst fluid