Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01455311
Status:
TERMINATED
Last Update Posted:
2013-02-15
First Post:
2011-10-17
Brief Title:
Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in the Diagnosis of Cystic Pancreatic Tumors
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to compare a sample of the cyst taken by a standard method fine needle aspiration to the sample taken by a new method using a device called the EchoBrush to see which method is more accurate at diagnosing cancer We will also look at proteins also called biomarkers in the samples to see if they predict whether or not the cyst is cancerous
Detailed Description:
Patients who meet the inclusion and exclusion criteria will be offered the study and those who consent will undergo Endoscopic Ultrasound EUS evaluation All patients who consent to the study will undergo Endoscopic Ultrasound guided fine needle aspiration EUS-FNA and EUS guided EchoBrush All patients will receive the recommended standard antibiotic prophylaxis Ciprofloxacin 400 mg IV given 30 minutes prior to EUS that is used prior to EUS-FNA of cystic pancreatic lesions and a prescription for oral Ciprofloxacin for 5 days post procedure standard of care
Participants with pancreatic cysts that are 10 mm but under 25 mm These patients will undergo standard EUS-FNA of cyst fluid From the first 19 participants 05cc of aspirated cyst fluid will be sent for Proteomic analysis and the rest for cytology EUS guided EchoBrush of the cyst wall will not be performed in this group of patients
Participants with pancreatic cysts that are 25 mm will undergo EUS guided Echobrush sampling of the cyst wall at the same time they undergo EUS-FNA This will be done using the standard technique that is described below
EUS guided cyst wall brushing and residual fluid aspirated after lavage with 2 cc of sterile normal saline The tip of the Echobrush and the saline used to lavage the cyst will be placed in the same specimen jar Specimen 2 based on the discussion with published experts on the EchoBrush technique It should be noted that the pancreatic cyst will be punctured with the 19G FNA needle only once to obtain the specimens mentioned above A single pass with EUS-FNA is the standard of care for pancreatic cysts and this study does not alter standard of care It should be noted that the two groups represent two samples from the same patient and same cystic lesion Therefore each patient will serve as their own internal control All patients will be considered for surgical resection Patients who do not undergo surgical resection will be followed up per standard of care
Participants with pancreatic cysts that are 10 mm but under 25 mm These patients will undergo standard EUS-FNA of cyst fluid From the first 19 participants 05cc of aspirated cyst fluid will be sent for Proteomic analysis and the rest for cytology EUS guided EchoBrush of the cyst wall will not be performed in this group of patients
Participants with pancreatic cysts that are 25 mm will undergo EUS guided Echobrush sampling of the cyst wall at the same time they undergo EUS-FNA This will be done using the standard technique that is described below
EUS guided cyst wall brushing and residual fluid aspirated after lavage with 2 cc of sterile normal saline The tip of the Echobrush and the saline used to lavage the cyst will be placed in the same specimen jar Specimen 2 based on the discussion with published experts on the EchoBrush technique It should be noted that the pancreatic cyst will be punctured with the 19G FNA needle only once to obtain the specimens mentioned above A single pass with EUS-FNA is the standard of care for pancreatic cysts and this study does not alter standard of care It should be noted that the two groups represent two samples from the same patient and same cystic lesion Therefore each patient will serve as their own internal control All patients will be considered for surgical resection Patients who do not undergo surgical resection will be followed up per standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None