Pancreatic DiseasesNCT05954221
Red Cell Lysis Buffer Application Versus Conventional Sample Processing in EUS-FNB
A study testing Red cell lysis buffer (RCLB) application and Conventional processing in people with Pancreatic Diseases, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Diseases
- What is being tested?
- Red cell lysis buffer (RCLB) application and Conventional processing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old; Solid pancreatic lesions confirmed by clinical and CT/MRI/ PET imaging. Signed written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Kai Xuan Wang, M.D contact
China1 site
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Jia Yi Ma, M.D, +8613621819595, 504043536@qq.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Pancreatic Diseases
- Being tested
- Red cell lysis buffer (RCLB) application, Conventional processing
- Keywords
- EUS-FNB, sample processing, solid pancreatic lesion
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red cell lysis buffer (RCLB) applicationProcedure or surgery
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 processingProcedure or surgery
The tissue is fixed with 10% formalin.
| Study group | Role | What they receive |
|---|---|---|
| Red cell lysis buffer (RCLB) group | Experimental | 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. Receives: Procedure: Red cell lysis buffer (RCLB) application |
| conventional group | Active comparator | 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. Receives: Procedure: Conventional processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 2 months
Diagnostic sensitivity
Diagnostic sensitivity was calculated as the proportion of true positive in patient cases.
Measured: 2 months
Diagnostic accuracy
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases
Measured: 2 months
Diagnostic specificity
Diagnostic specificity were calculated as proportion of true negative in healthy cases
Measured: 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
Measured: 2 months
RNA and DNA adequancy
Compare the percentage of samples with sufficient RNA and DNA that could be extracted from.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start15 Sep 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao Shen Li, M.D, Principal investigator, Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954221
- Sponsor's protocol ID
- RBC lysis buffer
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Cell Lysis Buffer Application Versus Conventional Sample Processing in Endoscopic Ultrasonography (EUS)-Guided Biopsy for Solid Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT05954221
- Acronym / sponsor ID
- RBC lysis buffer
- Conditions
- Pancreatic Diseases
- Keywords
- EUS-FNB, sample processing, solid pancreatic lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red cell lysis buffer (RCLB) group | Experimental | Procedure: Red cell lysis buffer (RCLB) applicationPatients 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. |
| conventional group | Active comparator | Procedure: Conventional processingPatients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be fixed with formalin as usual and underwent histological evaluation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 80 years old; Solid pancreatic lesions confirmed by clinical and CT/MRI/ PET imaging. Signed written informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red cell lysis buffer (RCLB) applicationThe 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. | Procedure or surgery | Red cell lysis buffer (RCLB) group |
| Conventional processingThe tissue is fixed with 10% formalin. | Procedure or surgery | conventional group |
Primary outcome
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)
8 secondary outcomes
Tissue integrity assessments
Time frame: 2 months
Macroscopic blood contamination assessments
Time frame: 2 months
Length of white core tissue
Time frame: 2 months
Diagnostic sensitivity
Time frame: 2 months
Diagnostic accuracy
Time frame: 2 months
Diagnostic specificity
Time frame: 2 months
Immunohistochemical assessment
Time frame: 2 months
RNA and DNA adequancy
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Xuan Wang, M.D contact
Zhao Shen Li, M.D principal investigator
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red cell lysis buffer (RCLB) application and Conventional processing in people with Pancreatic Diseases, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Yi Ma, M.D (+8613621819595, 504043536@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microscopic blood contamination assessments (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.