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NCT04164017
Impact of Suction in the EUS-guided Fine Needle Biopsy of Solid Pancreatic Lesions
NA trial testing EUS-guided FNB with Syringe Suction in Biopsy, Fine-Needle in 100 participants. Status unknown.
1 April 2020
Quick facts
| Lead sponsor | Centro Hospitalar De São João, E.P.E. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 100 |
| Start date | 1 June 2019 |
| Primary completion | 1 April 2020 |
| Estimated completion | 1 April 2020 |
| Sites | 1 location across Portugal |
Drugs / interventions tested
- EUS-guided FNB with Syringe Suction
- EUS-guided FNB without Syringe Suction
Conditions studied
- Biopsy, Fine-Needle — all drugs for Biopsy, Fine-Needle →
- Endosonography — all drugs for Endosonography →
- Pancreatic Neoplasm — all drugs for Pancreatic Neoplasm →
Sponsor
Centro Hospitalar De São João, E.P.E.
Who can join
18 and older, any sex, with Biopsy, Fine-Needle or Endosonography. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Tissue acquisition by Endoscopic Ultrasound (EUS) has become a modality of diagnosis and clinical orientation for several diseases. Although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/FNA), the importance of obtaining a core for histological examination (by fine-needle biopsy/FNB) has recently been recognized. Currently, there is no clear establishment of the usefulness of syringe suction for the diagnostic accuracy of solid pancreatic lesions when FNB is used. Because of that, the investigators aimed to compare sensitivity, sample adequacy, and diagnostic yield of solid pancreatic lesions EUS-guided sampling using with and without syringe suction. The study will be conducted on a consecutive sample of patients proposed to perform EUS for solid pancreatic lesions characterization, in which the clinical and imaging findings justify the need for an FNB. For each case, FNB will be performed using two punctures: one with 20mL syringe suction, and another without suction. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis. Clinical care during and after the procedure will follow the existing guidelines. Participants will undergo a single clinical evaluation (at the time of endoscopy and recovery) without the need for follow-up visits.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04164017 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centro Hospitalar De São João, E.P.E.
- Last refreshed: 15 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04164017.
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