Clinical trial · Interventional
Utility of EUS-guided Microbiopsies in Pancreatic Cystic Lesions
Utility of EUS-guided Microbiopsies Combined With Auxiliary Molecular Techniques in the Workup of Pancreatic Cystic Lesions
NCT03578445CI-TRIAL-00042129completedN/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)
The purpose of this study is to determine clinical impact of EUS-guided microbiopsy procedure and supplementary molecular analyses compared to standard diagnostic workup of pancreatic cysts. The hypothesis is that a combination of previously mentioned modalities may change the management of some pancreatic cystic lesions, increase the diagnostic accuracy and optimize the discrimination between high- and low-risk pancreatic cysts.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| IPMN | — | UNRESOLVED | — |
| Mucinous Cyst | — | UNRESOLVED | — |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cyst | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided microbiopsy | Device | — | UNRESOLVED |
| Next Generation Sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with a pancreatic cystic lesion
- interventionNames
- Device: EUS-guided microbiopsy
- Diagnostic Test: Next Generation Sequencing
Primary outcomes (1)
- measure
- Clinical impact of EUS-guided microbiopsies in patients with pancreatic cystic lesions
- timeFrame
- 3 weeks
- description
- All patients are evaluated at a multidisciplinary conference prior to microbiopsy procedure. A primary decision is made based on available imaging modalities and/or cyst fluid analysis (operation, follow-up or discontinuation from follow-up). Subsequently, each patient is once again evaluated at a multidisciplinary conference, and a possible change in management is noted. Clinical impact is defined as a proportion of the patients where a change in clinical management is observed.
Secondary outcomes (5)
- measure
- Technical success of EUS-guided microbiopsy procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 18 years old or above * Able to provide informed consent * Pancreatic cyst with a diameter of 15 mm or above OR pancreatic cyst of any size with any one of either high-risk stigmata or worrisome features (obstructive jaundice in patients with a cyst in the head of the pancreas, solid component/mural nodule, thickened/enhancing cyst wall, main pancreatic duct ≥ 10 mm or abrupt change of main pancreatic duct diameter with distal atrophy) Exclusion Criteria: * Lactating and pregnant females * Cystic lesions with a predominantly solid component, suspected of malignancy * Patients with uncorrected coagulopathy (international normalized ratio \> 1.5 or platelet count \< 50 109/L) * Patients with previous history of pancreatic cancer * Patients with a history of major stomach surgery (e.g. Billroth 1 and 2, gastrectomy, gastric bypass, esophagectomy, resection of the liver or pancreas) * Patients with disseminated malignant disease * Patients unfit for surgery * Patients where EUS-guided puncture of the lesion is not presumed technically feasible and/or safe * Patients with systemic immunosuppressive disease or receiving systemic immunosuppressive treatment * Patients with a history of recent pancreatitis (within 3 months)
References
Publications (1)
- DERIVEDRift CV, Melchior LC, Kovacevic B, Klausen P, Toxvaerd A, Grossjohann H, Karstensen JG, Brink L, Hassan H, Kalaitzakis E, Storkholm J, Scheie D, Hansen CP, Lund EL, Vilmann P, Hasselby JP. Targeted next-generation sequencing of EUS-guided through-the-needle-biopsy sampling from pancreatic cystic lesions. Gastrointest Endosc. 2023 Jan;97(1):50-58.e4. doi: 10.1016/j.gie.2022.08.008. Epub 2022 Aug 12. PMID 35964683