Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
After patients have been screened and have signed informed consent, they will be taken to the endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration (FNA), the subject will be randomized to 1 of 4 groups:
Follow-up Phone Call Phase:
Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.
All adult patients referred to Florida Hospital for evaluation of a pancreatic mass lesion will be eligible for entry into the study. Patients will be approached at the time of procedural consent for the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22 gauge with suction | Active Comparator | EUS-FNA of pancreatic masses will be performed with a 22 gauge needle using suction. |
|
| 22 gauge without suction | Active Comparator | EUS-FNA of pancreatic masses will be performed with a 22 gauge needle without suction. |
|
| 25 gauge with suction | Active Comparator | EUS-FNA of pancreatic masses will be performed with a 25 gauge needle using suction. |
|
| 25 gauge without suction | Active Comparator | EUS-FNA of pancreatic masses will be performed with a 25 gauge needle without suction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-FNA of pancreatic masses | Procedure | EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of diagnostic cell block specimens obtained according to needle size and the use of suction. | The use of suction and a larger gauge needle during EUS-FNA is likely to increase the diagnostic yield of cell block. This may in turn translate to improved diagnosis and hence expedite patient management | 7 days (cell block processing in lab) |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic adequacy of FNA cytology | 1. Diagnostic adequacy of FNA cytology samples and comparison between the two needle sizes and the effect of application of suction | 24 hours |
| Median number of passes to diagnosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shyam S Varadarajulu, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Orlando | Florida | 32803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29535060 | Derived | Bang JY, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Endoscopic Ultrasound-guided Specimen Collection and Evaluation Techniques Affect Diagnostic Accuracy. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1820-1828.e4. doi: 10.1016/j.cgh.2018.03.004. Epub 2018 Mar 11. |
Not provided
Not provided
There is no plan to share Individual Participant Data.
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 18, 2020 | |
| Reset | Oct 13, 2020 | |
| Release | Jul 11, 2023 | |
| Reset | Jul 28, 2023 | |
| Release | Oct 12, 2023 | |
| Reset | Nov 3, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2020 | Oct 13, 2020 | |||
| Jul 11, 2023 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 22 gauge needle | Device |
|
| 25 gauge needle | Device |
|
2. Median no. of passes required to obtain diagnostically adequate cytological samples, and comparison between the two needle sizes and suction vs. no suction
| 24 hours |
| Specimen bloodiness | 3. Specimen bloodiness and comparison between the two needle sizes and two techniques (with and without suction) | 24 hours |
| Rate of needle dysfunction | 4. Rate of needle dysfunction and technical failure, and comparison between the two needle sizes and two techniques (with and without suction) | 24 hours |
| Rate of complications | 5. Rate of complications following EUS-FNA, and comparison between the two needle sizes and two techniques (with and without suction) | 3 days |
| Jul 28, 2023 |
| Oct 12, 2023 | Nov 3, 2023 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |