22 G - 25 G SINS Trial for Pancreatic Masses
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - 89 |
| Updated: | 2/17/2019 |
| Start Date: | July 28, 2014 |
| End Date: | September 30, 2018 |
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.
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.
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.
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)
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