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

Naval Military Medical University

Status: Not yet enrolling

Conditions: Pancreatic Diseases

Treatments: Procedure: Red cell lysis buffer (RCLB) application; Procedure: Conventional processing

Study type: Interventional

Funder types: Other

Identifiers

NCT05954221

RBC lysis buffer

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups

Red cell lysis buffer (RCLB) group

Experimental group

Description:

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.

Treatment:

Procedure: Red cell lysis buffer (RCLB) application

conventional group

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional processing