search
Back to results

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

Primary Purpose

Pancreatic Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Red cell lysis buffer (RCLB) application
Conventional processing
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Diseases focused on measuring EUS-FNB, sample processing, solid pancreatic lesion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Red cell lysis buffer (RCLB) group

conventional group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
July 12, 2023
Last Updated
September 5, 2023
Sponsor
Changhai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05954221
Brief Title
Red Cell Lysis Buffer Application Versus Conventional Sample Processing in EUS-FNB
Official Title
Red Cell Lysis Buffer Application Versus Conventional Sample Processing in Endoscopic Ultrasonography (EUS)-Guided Biopsy for Solid Pancreatic Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Diseases
Keywords
EUS-FNB, sample processing, solid pancreatic lesion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Red cell lysis buffer (RCLB) group
Arm Type
Experimental
Arm 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.
Arm Title
conventional group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Red cell lysis buffer (RCLB) application
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional processing
Intervention Description
The tissue is fixed with 10% formalin.
Primary Outcome Measure Information:
Title
Microscopic blood contamination assessments
Description
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)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Tissue integrity assessments
Description
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.
Time Frame
2 months
Title
Macroscopic blood contamination assessments
Description
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).
Time Frame
2 months
Title
Length of white core tissue
Description
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.
Time Frame
2 months
Title
Diagnostic sensitivity
Description
Diagnostic sensitivity was calculated as the proportion of true positive in patient cases.
Time Frame
2 months
Title
Diagnostic accuracy
Description
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases
Time Frame
2 months
Title
Diagnostic specificity
Description
Diagnostic specificity were calculated as proportion of true negative in healthy cases
Time Frame
2 months
Title
Immunohistochemical assessment
Description
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
Time Frame
2 months
Title
RNA and DNA adequancy
Description
Compare the percentage of samples with sufficient RNA and DNA that could be extracted from.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Yi Ma, M.D
Phone
+8613621819595
Email
504043536@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Xuan Wang, M.D
Email
wangkaixuan224007@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Shen Li, M.D
Organizational Affiliation
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Yi Ma, M.D
Phone
+8613621819595
Email
504043536@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs