Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prospective Study Comparing Methods of Obtainment of Specimen After EUS-FNA in Patients With Peri-pancreatic Mass
Brief Summary: EUS-guided FNA has been proved to be a safe and useful method for tissue sampling of gastrointestinal track lesions and other organ lesions including mediastinal and intra-abdominal lymph nodes, pancreas and hepatobiliary tree. The usefulness of EUS-FNA depends on several factors. For example, experience of the endosonographers, adequate sampling, sample preparing, accurate interpretation by the cytopathologist and on-site cytopathology interpretation. However, in many hospitals, no cytopathologist can be present during EUS-FNA. Therefore, determining appropriate methods to obtain and prepare EUS-guided FNA are important to make correct a diagnosis without on-site cytopathologist.

Suction with a self-retracting 10-mL syringe will likely bring in more cellularity but also more blood. Some endosonographers use no suction, others use constant suction. Usually specimen is expelled from a needle with pushing the stylet into the needle. But use of the stylet during EUS-FNA is difficult and time consuming process. Injecting air was not recommended, because of spraying out uncontrollably, increasing risk of air artifact and specimen clotting. However, there is no further study which one is the appropriate, suction or no suction and pushing the stylet or injecting air until now.

The hypothesis and aim of the prospective randomized controlled trials are as follows:

First hypothesis: There was no difference in the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.

Aim #1 : To compare the adequacy, cellularity, bloodiness, contamination, air artifact in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.

Second hypothesis: There was no difference in sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.

Aim #2 : To compare the sensitivity, specificity, diagnostic accuracy, positive predictive value, negative predictive value and statistical agreement in specimen obtained by each methods, suction or no suction and pushing the stylet or injecting air.


Options:
A: Arm Label: 1.EUS-FNA with or without suction; Type: EXPERIMENTAL; Interventions: Procedure: 1.EUS-FNA with or without suction | Arm Label: 2.Pushing the stylet or injecting air; Type: EXPERIMENTAL; Interventions: Procedure: 2.Pushing the stylet or injecting air | Intervention Type: PROCEDURE; Name: 1.EUS-FNA with or without suction; Assigned to Arm(s): 1.EUS-FNA with or without suction | Intervention Type: PROCEDURE; Name: 2.Pushing the stylet or injecting air; Assigned to Arm(s): 2.Pushing the stylet or injecting air
B: Arm Label: EchoTip HD ProCore 22 Gauge; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic control | Arm Label: Echo Tip 22 Gauge; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Puncture with fine needle aspiration under endoscopic ultrasonographic control | Intervention Type: PROCEDURE; Name: Puncture with fine needle aspiration under endoscopic ultrasonographic control; Assigned to Arm(s): Echo Tip 22 Gauge, EchoTip HD ProCore 22 Gauge
C: Arm Label: EUS FNA with 2 passes; Type: ACTIVE_COMPARATOR; Interventions: Procedure: EUS FNA with 2 passes | Arm Label: EUS FNA with 4 passes; Type: ACTIVE_COMPARATOR; Interventions: Procedure: EUS FNA with 4 passes | Intervention Type: PROCEDURE; Name: EUS FNA with 2 passes; Assigned to Arm(s): EUS FNA with 2 passes | Intervention Type: PROCEDURE; Name: EUS FNA with 4 passes; Assigned to Arm(s): EUS FNA with 4 passes
D: Arm Label: Pancreatic adenocarcinoma; Type: N/A; Interventions: N/A | Arm Label: Chronic pancreatitis; Type: N/A; Interventions: N/A

Answer: A