Solid Pancreatic Tumor Clinical Trial
Official title:
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: a Randomized Controlled Trial
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.
| Status | Completed |
| Enrollment | 235 |
| Est. completion date | December 15, 2019 |
| Est. primary completion date | December 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age > 18 years - Patients referred for EUS evaluation of a definite solid pancreatic mass noted on computed tomography(CT)/Magnetic resonance imaging(MRI)/EUS, in which malignancy is suspected with no previous histological diagnosis Exclusion Criteria: - Age < 18 years, pregnant patients. - Uncorrectable coagulopathy Prothrombin time (PT) >50% of control, Partial Thromboplastin time (PTT) >50 sec, or International normalized ratio (INR) >1.5 and/or uncorrectable thrombocytopenia platelet count<50, 000109/L. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Alberta | Edmonton | Alberta |
| Canada | Moncton Hospital | Moncton | New Brunswick |
| Canada | Jewish General Hospital | Montréal | Quebec |
| Canada | McGill University Health Centre | Montréal | Quebec |
| Canada | The Ottawa Hospital | Ottawa | Ontario |
| Canada | Vancouver General Hospital | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Chang KJ, Katz KD, Durbin TE, Erickson RA, Butler JA, Lin F, Wuerker RB. Endoscopic ultrasound-guided fine-needle aspiration. Gastrointest Endosc. 1994 Nov-Dec;40(6):694-9. — View Citation
Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. — View Citation
Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. — View Citation
Kandel P, Tranesh G, Nassar A, Bingham R, Raimondo M, Woodward TA, Gomez V, Wallace MB. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc. 2016 Dec;84(6):1034-1039. doi: 10.1016/j.gie.2016.03.1405. Epub 2016 Mar 24. — View Citation
Klapman JB, Logrono R, Dye CE, Waxman I. Clinical impact of on-site cytopathology interpretation on endoscopic ultrasound-guided fine needle aspiration. Am J Gastroenterol. 2003 Jun;98(6):1289-94. — View Citation
Kulesza P, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspiration: sampling, pitfalls, and quality management. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1248-54. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnostic accuracy | Defined as (true positive + true negative)/all samples | 12 months | |
| Primary | 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 | |
| Primary | 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 | Diagnostic characteristics | sensitivity, specificity, positive and negative predictive value | 6 to 12 months of data collection and 3 to 6 months of data analysis. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | Procedural time | Time spent during the procedure | 6 to 12 months of data collection and 3 to 6 months of data analysis. | |
| Secondary | 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. |