22 G - 25 G SINS Trial for Pancreatic Masses (SINS)

Randomized Trial Examining the Relationship Between Procedural Technique and Specimen Evaluation Methods in Patients Undergoing Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) of Pancreatic Masses

After patients have been screened and have signed informed consent, they will be taken to the endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration (FNA), the subject will be randomized to 1 of 4 groups:

• 22 gauge (G) needle with suction
• 25 G needle with suction
• 22 G needle without suction
• 25 G needle without suction

Follow-up Phone Call Phase:

Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Procedure: EUS-FNA of pancreatic masses; Device: 22 gauge needle; Device: 25 gauge needle

Detailed Description

All adult patients referred to Florida Hospital for evaluation of a pancreatic mass lesion will be eligible for entry into the study. Patients will be approached at the time of procedural consent for the study.

1. After written informed consent is taken, Endoscopic Ultrasound (EUS) will be performed under conscious sedation.
2. At the time of EUS, patients who require FNA will be randomized to the two needles (22 G or 25 G needles) and to the two techniques (using suction or not using suction).
3. Computer-generated randomization assignments using the block randomization method will be obtained from the statistician prior to study enrollment. These will be placed in sequentially numbered sealed opaque envelopes and opened by the endoscopy nurse immediately after the decision to perform FNA is made. The randomization sequence will specify the needle size to be used and whether or not suction will be applied for FNA.
4. FNA will be performed in the standard fashion using one of the designated needle sizes (using the fanning technique to pass the needle 12-16 times into the lesion) by one of the experienced endosonographers in the unit. The needle stylet will be left in place for the first pass and then removed for subsequent passes. Suction will be applied during aspiration of the mass as dictated by the randomization sequence.
5. First two passes will be performed to obtain tissue sample for cell block analysis. Therefore, the tissue obtained with the first and second passes will be expressed onto a slide and into test tubes for cell block analysis.
6. From the third pass onwards, the aspirate obtained will be examined onsite by the cytopathologist, who will be available to interpret the slides immediately to determine diagnostic adequacy of the sample per standard practice. Once the diagnosis is made and the adequacy of the sample is affirmed by the cytopathologist, the procedure will be stopped and the echoendoscope will be withdrawn from the patient.
7. Total number of passes to obtain a diagnostic cytological aspirate made will be recorded at the time of procedure, as well as the occurrence of needle dysfunction, technical failure, and any immediate complications.
8. The samples taken will be transported to the pathology lab (per standard practice) where the cellular aspirate and cell block samples will be evaluated by the pathologist. 10% of samples from each subgroup (i.e. 22G with suction, 22G without suction, 25G with suction, 25G without suction) will be further analyzed for the presence of molecular markers for malignancy.
9. After the appropriate observations are deemed satisfactory, patients will be discharged as per unit policy.
10. Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA
2. Age ≥ 19 years

Exclusion Criteria:

1. Age <19 years
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <80,000/ml)
4. Unable to provide consent for any reason
5. Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 22 gauge with suction; EUS-FNA of pancreatic masses will be performed with a 22 gauge needle using suction.	Procedure: EUS-FNA of pancreatic masses; EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.; Device: 22 gauge needle
Active Comparator: 22 gauge without suction; EUS-FNA of pancreatic masses will be performed with a 22 gauge needle without suction.	Procedure: EUS-FNA of pancreatic masses; EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.; Device: 22 gauge needle
Active Comparator: 25 gauge with suction; EUS-FNA of pancreatic masses will be performed with a 25 gauge needle using suction.	Procedure: EUS-FNA of pancreatic masses; EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.; Device: 25 gauge needle
Active Comparator: 25 gauge without suction; EUS-FNA of pancreatic masses will be performed with a 25 gauge needle without suction.	Procedure: EUS-FNA of pancreatic masses; EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.; Device: 25 gauge needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of diagnostic cell block specimens obtained according to needle size and the use of suction.	The use of suction and a larger gauge needle during EUS-FNA is likely to increase the diagnostic yield of cell block. This may in turn translate to improved diagnosis and hence expedite patient management	7 days (cell block processing in lab)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic adequacy of FNA cytology	1. Diagnostic adequacy of FNA cytology samples and comparison between the two needle sizes and the effect of application of suction	24 hours
Median number of passes to diagnosis	2. Median no. of passes required to obtain diagnostically adequate cytological samples, and comparison between the two needle sizes and suction vs. no suction	24 hours
Specimen bloodiness	3. Specimen bloodiness and comparison between the two needle sizes and two techniques (with and without suction)	24 hours
Rate of needle dysfunction	4. Rate of needle dysfunction and technical failure, and comparison between the two needle sizes and two techniques (with and without suction)	24 hours
Rate of complications	5. Rate of complications following EUS-FNA, and comparison between the two needle sizes and two techniques (with and without suction)	3 days

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Shyam S Varadarajulu, MD, AdventHealth

Publications and helpful links

General Publications

• Bang JY, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Endoscopic Ultrasound-guided Specimen Collection and Evaluation Techniques Affect Diagnostic Accuracy. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1820-1828.e4. doi: 10.1016/j.cgh.2018.03.004. Epub 2018 Mar 11.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2014
• Primary Completion (Actual): April 3, 2016
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimate): April 23, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 618366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share Individual Participant Data.