Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

The 22-gauge core biopsy needle with reverse bevel design (EchoTip® Procore™) will be compared prospectively to the standard straight hollow-core 22-gauge or 25-gauge FNA needle already used in our clinical practice for the diagnosis of solid pancreatic lesions.

Two passes performed with the standard 22-gauge or 25-gauge straight hollow core needle and two passes will be performed using the 22-gauge EchoTip® Procore™ needle. All passes will be taken from a single lesion and from the same endoscopic location.

Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle

Brian Weston, MD

The goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic lesions.

An endoscopic ultrasound-guided needle biopsy or FNA is a special endoscopic procedure used to sample lesions within or next to the digestive tract, including the pancreas. The needle is used to collect material for diagnosis. A special lighted, flexible tube called an endoscope is inserted through the mouth, into the stomach and small intestine. The endoscope also has an ultrasound probe at its tip which can be used to see the pancreas, which is located behind the stomach. The doctor will then use the ultrasound to guide the needle biopsy or FNA.

In this procedure, an average of 4 needle passes (needle sticks) is needed to collect enough tissue for diagnosis. However, the number of passes can be higher or lower, depending on the individual lesion and success of the needle passes.

If participant agrees to take part in this study, 2 different needles (the standard straight hollow-core needle and the new EchoTip® Procore™ needle) will be used to sample the pancreas lesion. Two (2) passes will be performed with each needle type and compared. If additional passes are needed for diagnosis, they will not be included in this study. After the first set of needle passes, the doctor may decide that more passes are needed.

Final test results will be taken from the diagnostic results from each needle pass. The results from both types of the needle will be included in the participant's medical record.

This is an investigational study. All needles used in this study are FDA approved and commercially available. Comparing the needles is investigational.

Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.

Comparison of a Novel 22-gauge Core Biopsy Needle

Prospective Comparison of a Novel 22-gauge Core Biopsy Needle With Reverse Bevel Design to a Standard Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) Needle for Diagnosis of Solid Pancreatic Mass Lesions

The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST and CST. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25 G needle. Each participant underwent 4 study passes, 2 passes with a standard 25 G needle using SST, plus a random assignment to one of two groups for 2 passes with the 22Gpc (1 pass for cytologic and 1 pass for histologic analysis) using SST (group 1) or CST (group 2). Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation.

The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST versus CST on EUS-FNA. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count \> 500 cells) or 3 (estimated cell count \> 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score \< 2 was considered inadequate. Histologic diagnostic adequacy was graded as either an adequate (score 2 or 3) or inadequate specimen for diagnosis.

The cytologic diagnostic adequacy of 22Gpc was compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count \> 500 cells) or 3 (estimated cell count \> 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score \< 2 was considered inadequate.

M.D. Anderson Cancer Center

Participants who are referred for EUS-FNA and consented will have their examination performed using two different needles: with the standard 22-gauge or 25-gauge straight hollow core needle

Standard Suction Technique (SST)

Capillary Suction Technique (CST)

SST: 2 passes with 25G for cytology, 1 pass each with 22Gpc for cytology and histology. Diagnostic adequacy scores compared by technique and by needle

CST: 2 passes with 25G for cytology, 1 pass each with 22Gpc for cytology and histology. Diagnostic adequacy scores compared by technique and by needle

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Weston,Brian,MD / Gastroenterology Hepatology & Nutrition

All pancreas masses: Score 0 or 1

All pancreas masses: Score 2 or 3

All pancreas masses: Score 3

Adenocarcinoma: Score 0 or 1

Adenocarcinoma: Score 2 or 3

Adenocarcinoma: Score 3

1 pass with 22Gpc for cytology, 1 pass with 22Gpc for histology using SST or CST. Diagnostic adequacy scores compared by technique for cytology and histology.

Standard Suction Technique (SST) Cytology

30 participants randomized to CST (Capillary Suction Technique)

Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle.

1 pass with 22Gpc for histology using SST. Diagnostic adequacy scores compared by technique for histology.

Standard Suction Technique (SST) Histology

1 pass with 22Gpc for histology using CST. Diagnostic adequacy scores compared by technique for histology.

Capillary Suction Technique (CST) Histology

Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle.

All patients: comparison of diagnostic adequacy of a single pass with a 22Gpc needle versus best of 2 passes with a standard 25G needle for cytological diagnosis.

22G Procore Needle

Standard 25G Needle

Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis

P30 participants randomized to SST (Standard Suction Technique)

30 participants randomized to CST (Capillary Suction Technique

Spots Global Cancer Trial Database for reverse bevel design