Red Cell Lysis Buffer Application Versus Conventional Sample Processing in Endoscopic Ultrasonography (EUS)-Guided Biopsy for Solid Pancreatic Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Changhai Hospital
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Microscopic blood contamination assessments
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Red cell lysis buffer (RCLB) group
Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be processed with red cell lysis buffer and underwent histological evaluation.
Intervention: Red cell lysis buffer (RCLB) application (Procedure)
conventional group
Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be fixed with formalin as usual and underwent histological evaluation.
Intervention: Conventional processing (Procedure)
Outcomes
Primary Outcomes
Microscopic blood contamination assessments
Time Frame: 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 Outcomes
- Tissue integrity assessments(2 months)
- Diagnostic sensitivity(2 months)
- RNA and DNA adequancy(2 months)
- Macroscopic blood contamination assessments(2 months)
- Length of white core tissue(2 months)
- Diagnostic accuracy(2 months)
- Diagnostic specificity(2 months)
- Immunohistochemical assessment(2 months)
Investigators
Zhaoshen Li
Department of Gastroenterology, Changhai Hospital
Changhai Hospital