Clinical trial · Interventional
Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions
Comparación de Tres técnicas de Biopsia Guiada Por Endosonografia de Lesiones sólidas pancreáticas
NCT04843956CI-TRIAL-00051281unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Patients with a diagnosis of solid pancreatic lesions evidenced by imaging studies (CT, MRI) and who undergo endoscopic ultrasound-guided biopsy will be selected. Biopsies will be taken using modified tip needles (FNB) three different methods (capillary by suction, capillary without suction and wet suction). From the results obtained from the pathology service, 3 variables will be assessed; Cellularity, blood contamination and suitability for a diagnosis.
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 Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic ultrasound-guided biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with solid pancreatic lesions
- description
- Patients who will undergo endoscopic ultrasound biopsy. Samples of at least 3 passes will be obtained, each pass obtained with a different technique (capillary with suction, capillary without suction and wet suction)
- interventionNames
- Diagnostic Test: Endoscopic ultrasound-guided biopsy
Primary outcomes (1)
- measure
- Quality of the sample in relation to the technique
- timeFrame
- 18 months
- description
- Establish if there is a difference in the quality of the sample in relation to the technique used to obtain it
Secondary outcomes (1)
- measure
- Sample contamination relative to technique
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years old * Any gender. * Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis. Exclusion Criteria: * That no lesion in the pancreas is identified by EUS. * Pancreatic lesions with a cystic component. * Alteration of coagulation parameters (INR\> 1.5, Platelets \<50,000 / mm3) or having taken antiplatelet agents or oral anticoagulants one week prior to the biopsy. * History of acute pancreatitis in the last 4 weeks. * Pregnant * Refusal or inability to sign informed consent
References
Publications (10)
- BACKGROUNDLee YN, Moon JH, Kim HK, Choi HJ, Choi MH, Kim DC, Lee TH, Cha SW, Cho YD, Park SH. Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study. Endoscopy. 2014 Dec;46(12):1056-62. doi: 10.1055/s-0034-1377558. Epub 2014 Aug 6. PMID 25098611
- BACKGROUNDCrino SF, Manfrin E, Scarpa A, Baldaque-Silva F, Carrara S, De Nucci G, Di Mitri R, Gines A, Iglesias-Garcia J, Itoi T, Kitano M, Nguyen NQ, Deprez PH, Poley JW, Shami VM, Tarantino I, Larghi A. EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial. Dig Liver Dis. 2019 Jun;51(6):901-906. doi: 10.1016/j.dld.2019.03.008. Epub 2019 Apr 8. PMID 30975612
- BACKGROUNDBor R, Vasas B, Fabian A, Balint A, Farkas K, Milassin A, Czako L, Rutka M, Molnar T, Szucs M, Tiszlavicz L, Kaizer L, Hamar S, Szepes Z. Prospective comparison of slow-pull and standard suction techniques of endoscopic ultrasound-guided fine needle aspiration in the diagnosis of solid pancreatic cancer. BMC Gastroenterol. 2019 Jan 9;19(1):6. doi: 10.1186/s12876-018-0921-9. PMID 30626331
- BACKGROUNDAadam AA, Oh YS, Shidham VB, Khan A, Hunt B, Rao N, Zhang Y, Tarima S, Dua KS. Eliminating the Residual Negative Pressure in the Endoscopic Ultrasound Aspirating Needle Enhances Cytology Yield of Pancreas Masses. Dig Dis Sci. 2016 Mar;61(3):890-9. doi: 10.1007/s10620-015-3860-0. Epub 2015 Sep 7. PMID 26346997
- BACKGROUNDLee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21. PMID 23433878
- BACKGROUNDKudo T, Kawakami H, Hayashi T, Yasuda I, Mukai T, Inoue H, Katanuma A, Kawakubo K, Ishiwatari H, Doi S, Yamada R, Maguchi H, Isayama H, Mitsuhashi T, Sakamoto N; Japan EUS-FNA Negative Pressure Suction Study Group. High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2014 Dec;80(6):1030-7.e1. doi: 10.1016/j.gie.2014.04.012. Epub 2014 Jun 2.