Pancreatic Diseases
Conditions
Keywords
EUS-FNB, solid pancreatic lesion, sample processing, 22D Franseen Needle
Brief summary
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.
Interventions
PROCEDUREMOSE application
The length of the tissue strips was judged using the specimen table and photographed for record. If the MVC of the first needle sample was ≥10mm, the tissue strip was placed into bottle A formalin for fixation. A second needle of tissue strip was pushed directly into the B-bottle formalin. If the first needle sample MVC was \< 10mm, the puncture was continued until the total length of sample MVC was ≥10mm, and all samples were placed into bottle A formalin.
PROCEDUREConventional processing
Two needles were punctured and all tissue strips were placed into bottle A formalin.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled) 1. 18-80 years old (inclusive), male and female; 2. patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis. 3. written informed consent was obtained;
Exclusion criteria
* (Before the trial, participants could not be enrolled if they met any of the following requirements) 1. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases; 2. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs; 3. confirmed pregnancy or possible pregnancy; 4. pathological diagnosis has been obtained by other methods; 5. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days. 6. other situations where EUS-FNB could not be performed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | 6 months | Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median puncture number | 2 months | In the MOSE group, if the MVC of the first needle sample was ≥10mm, an additional needle was inserted. If the MVC of the first stitch is \< 10mm, continue to puncture until the total length of the MVC of the sample is ≥10mm. In the non-MOSE group, fixed puncture was performed with 2 needles. |
| Tissue adequacy | 2 months | Grade A, existing core tissue (defined as structurally intact tissue with a long axis length of at least 550 μm) that clearly characterizes the lesion and is sufficient for diagnosis; Grade B, the presence of core fragments that do not meet the histological criteria for structural integrity, but can still be diagnosed based on cell morphology; Grade C, no diseased tissue is found and no diagnosis can be made based on the sample. |
| Puncture time | 2 months | The puncture time of the MOSE group was defined as the beginning of puncture to the end of the confirmation of sufficient MOSE, and the puncture time of the non-MOSE group was defined as the beginning of puncture to the end of 2 stitches. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic sensitivity | 2 months | Diagnostic sensitivity was calculated as the proportion of true positives in patient cases. |
| Diagnostic specificity | 2 months | Diagnostic specificity was calculated as proportion of true negative in healthy cases. |
Countries
China
Contacts
Primary ContactJia Yi Ma, M.D
Backup ContactKai Xuan Wang, M.D
Outcome results
None listed