Pancreatic Diseases
Conditions
Keywords
EUS-FNB, sample processing, solid pancreatic lesion
Brief summary
The goal of this clinical trial is to evaluate the application of red cell lysis buffer (RCLB) versus conventional sample processing in endoscopic ultrasonography (EUS)-guided biopsy for solid pancreatic lesions. The main questions it aims to answer are: whether the application of red cell lysis buffer improves histological tissue quality by decreasing blood contamination. Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-guided biopsy. The obtained specimens will be processed by RCLB and conventional formalin solution. Researchers will compare the blood contamination score of specimens in RCLB group with the conventional group see if the blood contamination can be improved.
Interventions
PROCEDURERed cell lysis buffer (RCLB) application
The tissue is lysed with 50% concentration of RCLB for 15 min on a shaking device. If the lysis is judged to be insufficient, it can be repeated one more time. Finally, the treated tissue will be fixed with 10% formalin.
PROCEDUREConventional processing
The tissue is fixed with 10% 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
18 to 80 years old; Solid pancreatic lesions confirmed by clinical and CT/MRI/ PET imaging. Signed written informed consent
Exclusion criteria
Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) Pregnant Patient is enrolled in any other clinical protocol or investigational trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microscopic blood contamination assessments | 2 months | Microscopic blood contamination is assessed by grading the percentage of the area of the blood cells in the entire ×40 field of view (score 3, \< 25 %; score 2, 25 % - 50%; score 1, \> 50 %; score 0, no material) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macroscopic blood contamination assessments | 2 months | Macroscopic visual quality of histopathological samples is assessed by grading the percentage of red (blood) component ejected from the needle on a glass slide (score 4, white tissue only; score 3, \< 25 %; score 2, 25 % - 50%; score 1, \> 50 %; score 0, no material). |
| Length of white core tissue | 2 months | MVC (macroscopically visible core), defined as a measurable whitish sample. After collecting the MVCs scattered in the samples, the samples were aligned using a needle, and their length was measured using a ruler. |
| Diagnostic sensitivity | 2 months | Diagnostic sensitivity was calculated as the proportion of true positive in patient cases. |
| Tissue integrity assessments | 2 months | The tissue integrity on histological analysis was also graded into 3 levels: Grade A, existing core tissue (defined as an architecturally intact piece of tissue with a long axis measuring at least 550 μm), which can clearly characterize the lesion, and is sufficient for diagnosis; Grade B, existing core fragments, which does not meet the criteria for architecturally intact histology, but can still yield a diagnosis based on cell morphology; and Grade C, no lesion tissue found, and a diagnosis cannot be made based on the sample. |
| Diagnostic specificity | 2 months | Diagnostic specificity were calculated as proportion of true negative in healthy cases |
| Immunohistochemical assessment | 2 months | Immunohistochemical assessment: a. Detect whether the expression of membrane proteins is the same in treated and untreated specimens from the additional 3 groups of patients. b. Grading the percentage of the area of non-specific staining of erythrocytes in the entire ×40 field of view. Score of 3, non-specific staining present in \< 25% of slides; score of 2, non-specific staining present in 25% - 50% of slides; score of 1, non-specific staining is present in \> - 50% of slides |
| RNA and DNA adequancy | 2 months | Compare the percentage of samples with sufficient RNA and DNA that could be extracted from. |
| Diagnostic accuracy | 2 months | Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases |
Countries
China
Contacts
Primary ContactJia Yi Ma, M.D
Backup ContactKai Xuan Wang, M.D
Outcome results
None listed