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2018-02-14
2019-12-15
2019-12-15
235
NCT03435588
McGill University Health Centre/Research Institute of the McGill University Health Centre
McGill University Health Centre/Research Institute of the McGill University Health Centre
INTERVENTIONAL
Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) With Rapid On-site Evaluation (ROSE) of Cytopathology vs. EUS-guided Fine Needle Biopsy (FNB) Alone in the Diagnosis of Pancreatic Solid Lesions
Currently, the best way to evaluate pancreatic masses is through endoscopic-guided needle sampling of the mass to determine the diagnosis by looking at the acquired tissue under a microscope. This is done by inserting a small camera (endoscope) through the mouth of the patient then advanced to the stomach and using ultrasound guidance a sample of the pancreas can be acquired through the stomach. The sampling is usually done with a small needle called fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate acquisition of cells for proper diagnosis under the microscope, which can lead to need for repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing the endoscopic procedures and evaluates each sampling performed immediately under the microscope and can give feedback to the endoscopist until enough cells has been acquired for a diagnosis. This method has been shown to increase the ability to diagnose pancreatic cancer but is expensive and requires significant amount of resources. New needles called core needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells but also the entire tissue structure (histology) and has been shown to be also very accurate in the diagnosis of pancreatic cancer. The purpose of this study is to compare endoscopy-guided biopsy of pancreatic masses with the new core needle (FNB), which can obtain more tissue for diagnosis vs. using a traditional needle (FNA) with the help of an immediate assessment of the obtained samples under the microscope to determine whether enough tissue has been obtained (ROSE). Both approaches have been shown to increase the accuracy of diagnosis in solid pancreatic masses but it is unclear which one is superior. This is a randomized trial meaning that the participants would either undergo biopsy with the new needle or with the traditional needle plus the addition of on-site assessment of the obtained samples. The advantage of the new needle is that it is easy to implement and likely much cheaper. If the investigators can show in our study that the new needles are as accurate as FNA with ROSE then FNB could be implemented across hospitals worldwide in an easier and less expensive fashion.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-01-15 | N/A | 2020-12-09 |
2018-02-09 | N/A | 2020-12-11 |
2018-02-19 | N/A | 2020-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: EUS-FNA with ROSE EUS-FNA with ROSE is performed with a 22 or 25 gauge FNA needle. The sampled specimen is expressed into a glass slide with a stylet; then using another glass slide the sample is spread out to make smears on two slides. Each pair of slides is then numbered | PROCEDURE: EUS
PROCEDURE: FNA with ROSE
|
| EXPERIMENTAL: EUS-FNB alone EUS-FNB is performed with a 22 or 25 gauge Core-needle. Tissue sampling technique is standardized between the endoscopists. Two passes are performed using the core needle. The biopsied samples are then expressed using a stylet into a jar filled with 10% f | PROCEDURE: EUS
PROCEDURE: FNB alone
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | Defined as (true positive + true negative)/all samples | 12 months |
| Final diagnosis of malignant pancreatic mass | Will be based on the following criteria: * Histological evidence of malignancy on the corresponding subsequent surgical specimen * Presence of an unresectable lesion during subsequent surgery * Malignant cytology/pathology on EUS-sampling followed by documented loco-regional progression/development of metastases on follow-up axial imaging. | 10 months |
| Final diagnosis of benign pancreatic mass | Will be based on the following criteria: * Surgical pathology or exploration showing the absence of malignancy * Follow-up imaging at > 6 months reporting stability of the pancreatic lesion * Cytological or histopathological diagnosis of benign disease with an appropriate clinical course of disease for minimum of 6 months | 10 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diagnostic characteristics | sensitivity, specificity, positive and negative predictive value | 6 to 12 months of data collection and 3 to 6 months of data analysis. |
| Specimen adequacy | Defined as the proportion of samples in which a final histopathological diagnosis could be made | 6 to 12 months of data collection and 3 to 6 months of data analysis. |
| Median number of needle passes | Number of times passing the needle for tissue acquisition | 6 to 12 months of data collection and 3 to 6 months of data analysis. |
| Procedural time | Time spent during the procedure | 6 to 12 months of data collection and 3 to 6 months of data analysis. |
| Rate of procedure-related adverse events | An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a procedure done, whether or not considered causally related to the procedure. A serious adverse event is an adverse event occurring during the procedure or any time after the procedure, that fulfills one or more of the following criteria: * Results in death * Is immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Is a congenital abnormality or birth defect * Is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above. | 6 to 12 months of data collection and 3 to 6 months of data analysis. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
