Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Prospective Multicenter Randomized Controlled Non-Inferiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Changhai Hospital
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy
Study Overview
Brief Summary
The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE.
Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen.
In Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was < 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin.
Researchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
- •18-80 years old (inclusive), male and female;
- •patients with pancreatic solid mass > 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
- •written informed consent was obtained;
Exclusion Criteria
- •(Before the trial, participants could not be enrolled if they met any of the following requirements)
- •contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
- •bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
- •confirmed pregnancy or possible pregnancy;
- •pathological diagnosis has been obtained by other methods;
- •refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.
- •other situations where EUS-FNB could not be performed.
Arms & Interventions
MOSE group
Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be evaluated by Macroscopic On-site Evaluation
Intervention: MOSE application (Procedure)
Non-mose group
Patients assigned to this group will receive EUS-FNB as routine. Two needles were punctured and all tissue strips were placed into bottle A formalin.
Intervention: Conventional processing (Procedure)
Outcomes
Primary Outcomes
Diagnostic accuracy
Time Frame: 6 months
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.
Secondary Outcomes
- Median puncture number(2 months)
- Tissue adequacy(2 months)
- Puncture time(2 months)
Investigators
Zhaoshen Li
Department of Gastroenterology, Changhai Hospital
Changhai Hospital