Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors

Pancreatic Tumors Clinical Trial

Official title:

Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in the Diagnosis of Cystic Pancreatic Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01455311
• Other study ID #: MCC-15973
• Status: Terminated
• Phase: N/A
• First received: October 17, 2011
• Last updated: February 12, 2013
• Start date: September 2010
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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, 0.5cc 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• All patients must meet clinical criteria to undergo an Endoscopic Ultrasound (EUS) with fine needle aspiration (FNA).

• Pancreatic cystic lesion with a minimum diameter of 10 mm noted on a previous cross-sectional imaging modality

• All races will be eligible

Exclusion Criteria:

• Coagulopathy defined as an prothrombin time (PT) > 13.5 seconds or partial thromboplastin time (PTT) > 35 seconds

• Thrombocytopenia defined as a platelet count < 50, 000

• Known pancreatic cancer

• Recent pancreatitis defined as an episode of pancreatitis within 4 weeks of study enrollment

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pancreatic Cyst
• Pancreatic Neoplasms
• Pancreatic Tumors

Intervention

Procedure:
• EUS Guided Fine Needle Aspiration
EUS-guided fine needle aspiration of the cyst fluid
• EUS Guided EchoBrush Sampling
EUS-guided brushing of the cyst wall

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rank The Diagnostic Accuracy of Specimen	The difference in diagnostic accuracy between the cytological grade of dysplasia on aspirated cyst fluid cytology (Specimen/ Group 1) and Echo Brush cytology (Specimen/ Group 2) when compared to surgical histology (Specimen 3).; Specifically, the cellularity (scored 0 to 3) of specimen 1 will be compared to specimen 2 using the two-sample proportion test. In addition, the Spearman's rank correlation will be used to calculate the correlation between cytological grade of dysplasia of specimen 1 to specimen 3, and the correlation between specimen 2 to specimen 3.	12 Months	No
Secondary	Cataloging Proteins	Cataloging proteins that are expressed in the cyst fluid collected from Pancreatic cystic tumors using Proteomic analysis.	12 Months	No

External Links

•   Moffitt Cancer Center Clinical Trials website