Cystic Tumors of Pancreas Clinical Trial
Official title:
Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in Cystic Tumors of the Pancreas
This study focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images. Characterizing more malignant tumors in the pancreas.
1. Medical background: Pancreatic cysts are quite rare, but are being increasingly
recognized due to the expanding use of cross-sectional imaging. They are classified into
three main classes: pseudocysts, serous cysts and mucinous cystic neoplasms. Either
intraductal papillary mucinous neoplasm (IPMN) or mucinous cyst adenomas / mucinous
cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or
pre-malignant and are considered for surgical resection, whereas pseudocysts and serous
cysts are considered benign and with a low potential for malignancy. Pseudocysts and
serous cysts are usually only considered for surgical resection when symptomatic or
enlarging.
2. Clinical background:
2.1. Endoscopic Ultrasound (EUS) is the diagnostic method of choice when a pancreatic
lesion is found incidentally on cross-sectional imaging. Endoscopic ultrasound-guided
fine needle aspiration (EUS-FNA) is a procedure where a target tissue in proximity to
the GI tract is biopsied using a fine needle guided in real time by an ultrasound probe
fixed at the tip of an endoscope. It may therefore be applied to pancreatic lesions, or
lymph nodes examination.
2.2. The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image
organs within or adjacent to the GI tracts with a miniprobe inserted through an
endoscopic needle. The fundamental technology as well as the principle of operation of
nCLE are substantially similar to pCLE.
3. Clinical evidence: Previous studies enabled to define interpretation criteria on the
micro-structure of benign pancreatic cysts. Less data is available on malignant
pancreatic cysts, except for a few images done in a pilot study of identification of
pancreatic cystic neoplasms.
4. Objectives:
4.1 The primary objective of the study is to assess the diagnostic performance of the
Cellvizio nCLE system in diagnosing pancreatic cysts, when associated with other
diagnostic information.
4.2 The secondary objectives are to assess the potential impact of the Cellvizio nCLE
system on patient management and validate the interpretation classification criteria
that were created during the previous studies.
5. Design:
This study will be conducted in a single center in China.
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