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NCT06994611
Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions
NA trial testing MOSE application in Pancreatic Diseases in 148 participants. Not yet recruiting.
26 March 2026
Quick facts
| Lead sponsor | Changhai Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | diagnostic |
| Enrollment | 148 |
| Start date | 25 June 2025 |
| Primary completion | 26 March 2026 |
| Estimated completion | 26 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- MOSE application
- Conventional processing
Conditions studied
- Pancreatic Diseases — all drugs for Pancreatic Diseases →
Sponsor
Changhai Hospital
Who can join
Adults 18 to 80, any sex, with Pancreatic Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE. Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen. In Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was \< 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin. Researchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06994611
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Other Changhai Hospital trials
Trials by the same sponsor.
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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 NCT06994611 (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 Changhai Hospital
- Last refreshed: 6 June 2025
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/NCT06994611.
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