Red Cell Lysis Buffer Application Versus Conventional Sample Processing in EUS-FNB

Pancreatic Diseases Clinical Trial

Official title:

Red Cell Lysis Buffer Application Versus Conventional Sample Processing in Endoscopic Ultrasonography (EUS)-Guided Biopsy for Solid Pancreatic Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05954221
• Other study ID #: RBC lysis buffer
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Changhai Hospital
• Contact: Jia Yi Ma, M.D
• Phone: +8613621819595
• Email: 504043536[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Diseases

Intervention

Procedure:
• Red 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.
• Conventional processing
The tissue is fixed with 10% formalin.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microscopic blood contamination assessments	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)	2 months
Secondary	Tissue integrity assessments	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.	2 months
Secondary	Macroscopic blood contamination assessments	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).	2 months
Secondary	Length of white core tissue	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.	2 months
Secondary	Diagnostic sensitivity	Diagnostic sensitivity was calculated as the proportion of true positive in patient cases.	2 months
Secondary	Diagnostic accuracy	Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases	2 months
Secondary	Diagnostic specificity	Diagnostic specificity were calculated as proportion of true negative in healthy cases	2 months
Secondary	Immunohistochemical assessment	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	2 months
Secondary	RNA and DNA adequancy	Compare the percentage of samples with sufficient RNA and DNA that could be extracted from.	2 months