Clinical trial · Observational
EUS-guided Through-the-needle Microforceps Biopsy Outcomes
How Does the EUS-guided Through-the-needle Microforceps Biopsy Improve Diagnosis of Pancreatic Cystic Lesions: A Multicenter Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided through-the-needle microbiopsy forceps (Moray) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TTNB group
- description
- Patients with PCLs suitable for biopsy.
- interventionNames
- Device: EUS-guided through-the-needle microbiopsy forceps (Moray)
Primary outcomes (1)
- measure
- The increment in diagnostic yield
- timeFrame
- 1 year
- description
- The diagnostic performance (accuracy) of the device will be compared to standard evaluation accuracy (cross-sectional imaging and EUS-FNA with cyst fluid analysis) and finally corroborated with surgery biopsy and 12 month follow up (gold standard).
Secondary outcomes (4)
- measure
- Percentage of technical success
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥ 18 years old patients. * Patints that agree to participate in the study. * PCLs ≥ 10mm, large enough to accommodate the microforceps. * Patients with PCLs and high-risk features (cyst \> 3 cm, thickened wall, dilated pancreatic duct, mural nodules and solid component). * New diagnosis of a PCL or interval changes in morphology on surveillance (cyst growth or high-risk features). * Patients with PCLs and symptoms (e. g. pancreatitis, abdominal pain, obstructive jaundice). * Patients with PCLs but without high-risk features and anxiety about the diagnosis. Exclusion Criteria: * Inability to provide informed consent for the procedure. * Pregnancy. * Platelet count less than 50,000/ml or International Normalized Rate (INR) \>2. * Esophageal stricture or any pathology that does noy allows performing EUS.
References
Publications (16)
- RESULTStark A, Donahue TR, Reber HA, Hines OJ. Pancreatic Cyst Disease: A Review. JAMA. 2016 May 3;315(17):1882-93. doi: 10.1001/jama.2016.4690. PMID 27139061
- RESULTLee KS, Sekhar A, Rofsky NM, Pedrosa I. Prevalence of incidental pancreatic cysts in the adult population on MR imaging. Am J Gastroenterol. 2010 Sep;105(9):2079-84. doi: 10.1038/ajg.2010.122. Epub 2010 Mar 30. PMID 20354507
- RESULTCorrea-Gallego C, Ferrone CR, Thayer SP, Wargo JA, Warshaw AL, Fernandez-Del Castillo C. Incidental pancreatic cysts: do we really know what we are watching? Pancreatology. 2010;10(2-3):144-50. doi: 10.1159/000243733. Epub 2010 May 17. PMID 20484954
- RESULTCho CS, Russ AJ, Loeffler AG, Rettammel RJ, Oudheusden G, Winslow ER, Weber SM. Preoperative classification of pancreatic cystic neoplasms: the clinical significance of diagnostic inaccuracy. Ann Surg Oncol. 2013 Sep;20(9):3112-9. doi: 10.1245/s10434-013-2986-6. Epub 2013 Apr 18. PMID 23595223
- RESULTRogart JN, Loren DE, Singu BS, Kowalski TE. Cyst wall puncture and aspiration during EUS-guided fine needle aspiration may increase the diagnostic yield of mucinous cysts of the pancreas. J Clin Gastroenterol. 2011 Feb;45(2):164-9. doi: 10.1097/MCG.0b013e3181eed6d2. PMID 20818233
- RESULTHong SK, Loren DE, Rogart JN, Siddiqui AA, Sendecki JA, Bibbo M, Coben RM, Meckes DP, Kowalski TE. Targeted cyst wall puncture and aspiration during EUS-FNA increases the diagnostic yield of premalignant and malignant pancreatic cysts. Gastrointest Endosc. 2012 Apr;75(4):775-82. doi: 10.1016/j.gie.2011.12.015. Epub 2012 Feb 7. PMID 22317883
- RESULTAlkaade S, Chahla E, Levy M. Role of endoscopic ultrasound-guided fine-needle aspiration cytology, viscosity, and carcinoembryonic antigen in pancreatic cyst fluid. Endosc Ultrasound. 2015 Oct-Dec;4(4):299-303. doi: 10.4103/2303-9027.170417.