Red Cell Lysis Buffer Application Versus Conventional Sample Processing in EUS-FNB
NCT ID: NCT05954221
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2023-09-15
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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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.
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 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.
Conventional processing
The tissue is fixed with 10% formalin.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
Department of Gastroenterology, Changhai Hospital
Principal Investigators
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Zhao Shen Li, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RBC lysis buffer
Identifier Type: -
Identifier Source: org_study_id
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