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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Diseases
• Intervention / Treatment: Procedure: Red cell lysis buffer (RCLB) application; Procedure: Conventional processing

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia Yi Ma, M.D; Phone Number: +8613621819595; Email: 504043536@qq.com
• Study Contact Backup: Name: Kai Xuan Wang, M.D; Email: wangkaixuan224007@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai hospital
      • Contact: Jia Yi Ma, M.D; Phone Number: +8613621819595; Email: 504043536@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Procedure: Conventional processing; The tissue is fixed with 10% formalin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Diagnostic sensitivity	Diagnostic sensitivity was calculated as the proportion of true positive in patient cases.	2 months
Diagnostic accuracy	Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases	2 months
Diagnostic specificity	Diagnostic specificity were calculated as proportion of true negative in healthy cases	2 months
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
RNA and DNA adequancy	Compare the percentage of samples with sufficient RNA and DNA that could be extracted from.	2 months

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Zhao Shen Li, M.D, Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: EUS-FNB; solid pancreatic lesion; sample processing
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: RBC lysis buffer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No