Clinical trial · Interventional
Wet Heparinized Suction for Abdominal Cancer
Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB) of Solid Abdominal Masses: A Randomized Prospective Trial
NCT05041335CI-TRIAL-00088780EUS HeparinwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Why stopped (as posted): study no longer proceeding
Summary
Brief summary (as posted)
The purpose of this research is to compare the amount and quality of tissue obtained by EUS-FNB when the device is flushed with an anticoagulant or "blood thinner" vs. saline a salt water solution as well as the use of a microsieve in order for the doctor to look at the tissue to check the acceptability of the specimens before sending for analysis. You will be randomly assigned (like a flip of a coin) to have either the blood thinner or the salt water solution placed within the needle being used to sample your abdominal tumor and to have either a sieve used or not. You will be one of 42 participants enrolled in this data collection study which includes 1 sites in the United States.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer of Esophagus | Malignant Esophageal Neoplasm | ALIAS | 0.90 |
| Cancer of Liver | Malignant Liver Neoplasm | ALIAS | 0.90 |
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
| Cancer of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microsieve | Other | — | UNRESOLVED |
| No heparin flush | Other | — | UNRESOLVED |
| No microsieve | Other | — | UNRESOLVED |
| wet heparinzed suction | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Heparin and microsieve
- description
- The needle will be prepped with 500 U heparin USP per 10 mL to coat the inside of the needle. The provider will expel the tissue onto the microsieve
- interventionNames
- Other: wet heparinzed suction
- Other: Microsieve
- type
- EXPERIMENTAL
- label
- Heparin and no microsieve
- description
- The needle will be prepped with 500 U heparin USP per 10 mL to coat the inside of the needle. The provider will expel the tissue into formalin
- interventionNames
- Other: wet heparinzed suction
- Other: No microsieve
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 year * Non-pregnant Patients * Patients with the presence of a solid abdominal mass as seen on diagnostic imaging \[ie. ultrasound (US), computer tomography (CT) or magnetic resonance imaging (MRI)\] scheduled to undergo EUS examination OR Patients who underwent a prior EUS-FNA/FNB for solid pancreatic mass and did not receive a conclusive diagnosis * Patients with platelet count \> 50,000 * Patients with International Normalized Ratio (INR) \< 1.5 Exclusion Criteria: * Age \< 18 years * Pregnant Patients * Patients who cannot consent for themselves * Patients with anticoagulants or anti-platelet agents (excluding aspirin) within the last 7-10 days * Patients with cystic abdominal masses * Patients with a platelet count \< 50,000 * Patients with an INR \> 1.5 * Patients with a heparin or porcine allergy * Patients with prior heparin induced thrombocytopenia (HIT) * Patient's with religious aversion to porcine-containing products
References
Publications (23)
- BACKGROUNDVilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available. PMID 1568614
- BACKGROUNDDumonceau JM, Deprez PH, Jenssen C, Iglesias-Garcia J, Larghi A, Vanbiervliet G, Aithal GP, Arcidiacono PG, Bastos P, Carrara S, Czako L, Fernandez-Esparrach G, Fockens P, Gines A, Havre RF, Hassan C, Vilmann P, van Hooft JE, Polkowski M. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017 Jul;49(7):695-714. doi: 10.1055/s-0043-109021. Epub 2017 May 16. PMID 28511234
- BACKGROUNDHebert-Magee S, Bae S, Varadarajulu S, Ramesh J, Frost AR, Eloubeidi MA, Eltoum IA. The presence of a cytopathologist increases the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration cytology for pancreatic adenocarcinoma: a meta-analysis. Cytopathology. 2013 Jun;24(3):159-71. doi: 10.1111/cyt.12071. PMID 23711182
- BACKGROUNDIglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12. PMID 21483464
- BACKGROUNDEloubeidi MA, Tamhane A, Jhala N, Chhieng D, Jhala D, Crowe DR, Eltoum IA. Agreement between rapid onsite and final cytologic interpretations of EUS-guided FNA specimens: implications for the endosonographer and patient management. Am J Gastroenterol. 2006 Dec;101(12):2841-7. doi: 10.1111/j.1572-0241.2006.00852.x. Epub 2006 Oct 6. PMID 17026562
- BACKGROUNDJhala NC, Jhala DN, Chhieng DC, Eloubeidi MA, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspiration. A cytopathologist's perspective. Am J Clin Pathol. 2003 Sep;120(3):351-67. doi: 10.1309/MFRF-J0XY-JLN8-NVDP.