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Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract using a 22 G needle

Patients referred for an EUS examination and EUS-FNA of a solid mass lesion adjacent to the upper GI tract using a 25 G needle

Peter Vilmann, Professor

The aim of the study is to compare the performance characteristics of EUS-FNA 22 Gauge needle and EUS FNA 25 Gauge needle in terms of cellularity and diagnostic yield for diagnosis of various pathologies, including lymph nodes, pancreatic, luminal and other lesions outlined by EUS.

Tissue acquisition by Endoscopic ultrasound plays a central role in diagnosis of several pathologies; this is achieved by obtaining cytological material with fine needle aspiration (FNA) needles that are able to provide smears of malignant cells. Several needles are at present available including 19 Gauge, 22 Gauge and 25 Gauge needles. A 22 Gauge needle is at present the standard needle and most of the EUS-FNA results are based on FNA with this needle.

Twenty five Gauge needles presently available on the market are distinctly small, highly flexible and may be easier to penetrate hard pancreatic tumors. There even is anecdotal messages that this size of needle may be able to traverse relatively large vascular structures without major risk. However, there is very scant data on whether a 25 G needle is comparable to a standard 22 G needle in terms of specimen cellularity and quality. There is only one small randomized trial published as an abstract by Lee et al reporting no statistical significant difference in cellularity between the two groups of needle size as judged by 2 different cytologists. However, the conclusion is dubious because considerable bias may be present since both needles were used in the same lesion. There is therefore a need for a properly designed randomized study comparing different needle sizes.

This study is a prospective randomized multicenter study. Patients referred to one of the participating departments for an EUS examination will be included prospectively. Linear EUS examination will be done with a linear echoendoscope for lymph nodes, mediastinal, pancreatic and other intra-abdominal masses.

Tumor and lymph node characteristics will be carefully described: size (long axis), echogeneity (hypoechoic, hyperechoic, mixed), and echostructure (homogenous, in-homogenous, calcifications), shape (round, oval, triangular), border (regular, irregular).

EUS-guided cell sampling will be performed with a 22 G (Medi-Globe, Sonotip II) and 25 G (Medi-Globe, Sonotip II) needles under EUS and Colour-Doppler guidance.

Needle order will be selected randomly, one single needle pr. Lesion. Three passes will be performed with either of the needles after randomization, using 6 uniform to and fro movements on every pass with continuous 10cc suction for the reason of standardization. The material will be expelled on separate numbered glass slides. The cytopathologist will review the material after staining blinded to the needle size and will be using standardized criteria for evaluation of cellularity.

Doubtless, this multicenter randomized controlled trial comparison, as any other experimental method, needs with necessity a serious statistical evaluation, bringing the benefits of improving the reliability and credibility of the findings thus obtained. Accordingly, both exploratory data analysis and statistical inference will be performed. Technically, the expected number of lesions to be included in the study will be 220, 110 in each group. Block randomization (block size = 4) will be used to ensure exactly equal treatment numbers at certain equally spaced points in the sequence of patients assignments (Knuth shuffle algorithm for random permutations).

For diagnostic tests the sensitivity, specificity positive and negative predictive value and diagnostic accuracy will be calculated and calculated separately for EUS-FNA during 1st pass, 2nd pass and 3rd pass by comparing the results with the final diagnosis. All results will be expressed as mean, standard deviation (SD) and confidence interval. Testing hypotheses will be used afterwards. An a priori power analysis will be performed to determine the appropriate sample size in order to achieve adequate power for the statistical tests subsequently used. The data from both groups will be compared by standard comparison tests chi-square test or Fishers exact test where appropriate. The level of statistical significance is stated as 0.05.

Pathology samples obtained through EUS-FNA biopsy processed by paraffin embedding.

Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles (FNA-22G-25G)

Multicenter Randomized Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles

University of Medicine and Pharmacy Craiova

Allgemeines Krankenhaus Celle, Celle, Germany

Pathologic Institute, Wittinger Strasse, Celle, Germany

Sana Hospital Lübeck GmbH, Lübeck, Germany

LungenClinic Grosshansdorf

University Hospital Schleswig-Holstein

University Hospital, Gentofte, Copenhagen

Professor

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

EUS-FNA of pancreatic masses will be performed with a 22 gauge needle using suction.

EUS-FNA of pancreatic masses will be performed with a 22 gauge needle without suction.

EUS-FNA of pancreatic masses will be performed with a 25 gauge needle using suction.

EUS-FNA of pancreatic masses will be performed with a 25 gauge needle without suction.

EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.

EUS-FNA of pancreatic masses

22 gauge needle

25 gauge needle

Shyam S Varadarajulu, MD

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.

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.

22 G - 25 G SINS Trial for Pancreatic Masses

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

There is no plan to share Individual Participant Data.

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

1. Diagnostic adequacy of FNA cytology samples and comparison between the two needle sizes and the effect of application of suction

2. Median no. of passes required to obtain diagnostically adequate cytological samples, and comparison between the two needle sizes and suction vs. no suction

3. Specimen bloodiness and comparison between the two needle sizes and two techniques (with and without suction)

4. Rate of needle dysfunction and technical failure, and comparison between the two needle sizes and two techniques (with and without suction)

5. Rate of complications following EUS-FNA, and comparison between the two needle sizes and two techniques (with and without suction)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles (FNA-22G-25G)	NCT01016288	Mediastinal Tum... Celiac, Perigas... Pancreatic Mass... Liver Masses Adrenal Masses		18 Years - 85 Years	University Hospital, Gentofte, Copenhagen
22 G - 25 G SINS Trial for Pancreatic Masses	NCT02424838	Pancreatic Neop...	EUS-FNA of panc... 22 gauge needle 25 gauge needle	19 Years - 89 Years	AdventHealth
22 G - 25 G SINS Trial for Pancreatic Masses	NCT02424838	Pancreatic Neop...	EUS-FNA of panc... 22 gauge needle 25 gauge needle	19 Years - 89 Years	AdventHealth

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