EUS-guided Through-the-needle Microforceps Biopsy Outcomes

Summary

INTRODUCTION: The diagnosis of pancreatic cystic lesions (PCLs) is increasing due to improvements of cross-sectional imaging. It is mandatory, for appropriate management, to make an accurate diagnosis and risk stratification, since some of these lesions may harbor malignancy or have potential for malignant transformation and hence surgical resection is required. Diagnostic evaluation of PCLs can be challenging, requiring a combination of different methods. Usually PCLs are been initially detected by cross-sectional imaging. However, imaging alone has not been shown to reliably identify the underlying pathology in PCLs with a high degree of accuracy. Hence, Endoscopic ultrasound with fine-needle aspiration (EUS-FNA) is routinely performed. EUS-FNA plays an important role in cyst characterization since allows morphological examination (EUS-B mode), aspiration for cytology and cyst fluid analysis for carcinoembryonic antigen (CEA), amylase and glucose levels; and allows to tissue sample in case of mural nodules o wall thickness. Even though EUS-FNA has been shown to be the test of choice for select lesions with high-risk features, has its limitations related to low sensitivity and specificity. The morphological characterization by EUS of PCL, as well as with the cross-sectional images, depends most of the time, on the subjective interpretation of the operator, which can be very difficult sometimes and depend on experience. A cyst fluid CEA cutoff of 192 ng/mL has been commonly accepted for differentiating mucinous from non-mucinous cysts. However, has the limitation of requiring at least 0.5 mL of cyst fluid for CEA analysis, has a relatively low sensitivity (75%) and specificity (84%), cannot differentiate cyst histotypes, and controversial results have been reported. Finally targeted cyst wall with the tip of the FNA needle can increase the diagnostic accuracy, yet the cytological yield with EUS-FNA remains low due to the relatively small tissue sample. Hence, diagnostic accuracy of currently available tools for evaluation of PCLs including cross-sectional imaging, EUS morphologic features, EUS-FNA for cyst fluid analysis and cytology is not perfect, leading to possible misdiagnosis.

Conditions

• Pancreatic Cyst

Interventions

DEVICE

EUS-guided through-the-needle microbiopsy forceps (Moray)

EUS-TTNB procedure technique. An endosonographer of each institution will perform the EUS procedures. Cysts morphology will be recorded and then punctured by using a 19-gauge EUS-FNA needle. Then the through-the-needle microbiopsy forceps (Moray) will be inserted through the needle into the cystic lumen. Microbiopsies will be obtained from the cyst wall randomly and from mural nodules or septae when observed. The open jaws of the forceps will be pushed onto the cyst wall, closed and pulled back to cause visible tenting. Two "bites" per pass will be obtained. Then the forceps will be removed and the specimen placed in formalin vials. The procedure will be repeated 2 times, or until 2 visible specimens are obtained. After completion of biopsies, the cyst fluid will be completely aspirated and sent for CEA, amylase, glucose and cytology analyses. If a mural nodule is visualized on EUS, it will be accessed separately by using the 19-gauge needle for EUS-FNA cytology.

Sponsors & Collaborators

• Institute of Gastroenterology and Advance Endoscopy

  lead OTHER

Principal Investigators

• Manuel Valero, MD · Institute of Gastroenterology and Advanced Endoscopy (IGEA)

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-22

Primary Completion

2022-10-01

Completion

2022-11-01

Countries

• Argentina

Study Locations