Clinical trial: NCT03435588
Section: Confidentiality
Subsections: Confidentiality

During your participation in this study, the study doctor and their team will collect and record information about you in a study file. They will only collect information required to meet the scientific goals of the study.  
The study file may include information from your medical chart, including your identity, concerning your past and present state of health, your lifestyle, as well as the results of the tests, exams, and procedures that you will undergo during this research project. Your research file could also contain other information, such as your name, sex, date of birth and ethnic origin. No tissue samples will be acquired for research purposes. All collected samples during EUS-guided biopsy will be received by the cytopathology lab and stored as per standard practice of the institution. All the information collected during the research project will remain strictly confidential to the extent provided by law. You will only be identified by a code number. The key to the code linking your name to your study file will be kept by the study doctor. To ensure your safety, a copy of this information and consent form be placed in your medical chart. As a result, any person or company to whom you give access to your medical chart will have access to this information. The study data will be stored for 25 years by the study doctor. The data may be published or shared during scientific meetings; however it will not be possible to identify you. For monitoring, control, safety, security, and marketing of a new study drug, your study file as well as your medical charts may be examined by a person mandated by Canadian or international regulatory authorities, such as Health Canada, as well as by representatives of the study sponsor, the institution, or the Research Ethics Board. All these individuals and organizations adhere to policies on confidentiality. You have the right to consult your study file in order to verify the information gathered, and to have it corrected if necessary. However, in order to protect the scientific integrity of the research project, accessing certain information before the project is ended may require that you be withdrawn from the study.
Clinical trial: NCT03435588
Section: Duration of Study Involvement
Subsections: 1. Duration And Number Of Visits

Your participation in this research project will last 6 months and will include 1 telephone interview following the initial procedure. The telephone interview will be approximately 5 minutes.
Clinical trial: NCT03435588
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Associated With The Research Study|Should You Suffer Any Harm

The risks associated with being part of this study is best classified as minimal risks. We do not anticipate any additional risks to you by being part of the study. All associated risks are part of standard of care and standard risks associated with EUS-guided biopsy of the pancreas. Both the novel core needles and traditional fine needle aspiration with rapid on-site evaluation of cytology are part of standard of care and are not experimental. However, if you have noticed side effects, whatever they may be, during this research study, you must tell the study doctor immediately, regardless of whether you think these effects are related to the procedure or not. Even once your participation in the study is over, do not hesitate to contact the study doctor if you experience a side effect that may be linked to the procedure. The study doctor and members of his or her team will answer any questions that you may have regarding the risks, discomforts and side effect associated with this study. Also, at each visit, the study doctor and members of his or her team will ask you questions about any side effects you may have experienced.

Should you suffer harm of any kind following the endoscopic procedure, or following any other procedure related to the research study, you will receive the appropriate care and services required by your state of health. By agreeing to participate in this research project, you are not waiving any of your legal rights nor discharging the study doctor, the sponsor or the institution, of their civil and professional responsibilities.
Clinical trial: NCT03435588
Section: Procedures
Subsections: Description Of The Research Procedures|2. Study Procedure|3. Tests And Procedures

This research study will take place at the McGill University Health Centre in including the Royal Victoria Hospital and Montreal General Hospital. Other centers involved in this study are the Jewish General Hospital and St-Michael's Hospital (University of Toronto).

When participating in this research project, you will be assigned to one of the following groups: Group 1: Endoscopic ultrasound guided biopsy of the pancreas with the traditional fine needle aspirate needle with the addition of rapid on-site cytopatholgy (cytopathologist looking at each biopsy samples as they are taken) Group 2: Endoscopic ultrasound guided biopsy with a novel core biopsy needle without on-site cytopathology Furthermore, this study is randomized which means that you will be assigned to one of the groups. You may not choose the group to which you will be assigned; this process is done randomly like flipping a coin. One person out of 2 (50%) will undergo biopsy with the new needle whereas one person out of 1 (50%) will undergo biopsy with a traditional needle with the addition of rapid on-site cytopathology evaluation. This is a single blind study, which means that you will not know which study procedure you will receive during this project. However, the study doctor will have access to this information.

During your participation in this research study, the study doctor or a member of the research team will conduct the following tests and procedures:  
| DESCRIPTION OF STUDY PROCEDURES                       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Procedure                                             | Description                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |
| Endoscopic ultrasound  guided biopsy of the  pancreas | Standard of care. Whether you are part of the study or not, EUS guided  biopsy of your pancreas will be recommended to you for the diagnosis  of the solid mass on your pancreas. The only difference is that by being  part of the study you would undergo biopsy with a novel core biopsy  needle or a regular fine needle aspirate with rapid on-site evaluation of  cytology of acquired samples. If you do not wish to participate in the  study then you would undergo EUS-guided biopsy with a traditional  fine needle aspirate alone. |  
The schedule of procedures for each visit is listed below:  
| SCHEDULE OF STUDY PROCEDURES   |         |         |
|--------------------------------|---------|---------|
| Procedure                      | Visit 1 | Visit 2 |
| (Day-0)                        | (Day-3) |         |
| EUS-guided biopsy              | X       |         |
| Telephone interview (5         | X       |         |
| min)                           |         |         |
Clinical trial: NCT03435588
Section: Purpose of Research
Subsections: Purpose Of The Research Study

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 you 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 we 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. For this research study, we will recruit 238 participants, men and women, ages 18 years and above. We anticipate 125 patients to be recruited at the McGill University Health Center.
Clinical trial: NCT03435588
Section: Voluntary Participation
Subsections: Voluntary Participation And The Right To Withdraw

Your participation in this research project is voluntary. Therefore, you may refuse to participate. You may also withdraw from the project at any time, without giving any reason, by informing the study doctor or a member of the research team. Your decision not to participate in the study, or to withdraw from it, will have no impact on the quality of care and services to which you are otherwise entitled, or on your relationship with the study doctor or clinical team. The study doctor, the Research Ethics Board, the funding agency, or the Sponsor may put an end to your participation without your consent. This may happen if new findings or information indicate that participation is no longer in your interest, if you do not follow study instructions, or if there are administrative reasons to terminate the project. If you withdraw or are withdrawn from the study, the information and biological material already collected for the study will be stored, analyzed and used to ensure the integrity of the study. Any new findings that could influence your decision to stay in the research project will be shared with you as soon as possible.