NCT01711294

Evaluation of PCLs Using Three EUS-FNA Needles

Completed NA Results posted Last updated 15 January 2021

What this trial tests

NA trial testing 19 G Flex Needle in Pancreatic Cystic Lesions in 250 participants. Completed in 18 December 2019.

Timeline

8 January 2013

Primary endpoint
6 June 2017

18 December 2019

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	250
Start date	8 January 2013
Primary completion	6 June 2017
Estimated completion	18 December 2019
Sites	8 locations across China, United States, India

Drugs / interventions tested

• 19 G Flex Needle
• 22 G Needle
• 19 G Needle

Conditions studied

• Pancreatic Cystic Lesions — all drugs for Pancreatic Cystic Lesions →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cystic Lesions. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume Primary · At procedure (Up to 1 hour)

Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)

Group	Value	95% CI
19G Flex Needle	78	± 35
22G Needle	74	± 39
19G Needle	73	± 41

Number of Patients With Related Adverse Events Secondary · 30 days

Adverse events related to study procedure or study device were tabulated. Adverse events were assessed from the index procedure up to 30 days post procedure.

Group	Value	95% CI
19G Flex Needle	3
22G Needle	2
19G Needle	1

Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure Secondary · Procedure (Up to 1 hour)

Change value is calculated as cyst volume measured after initial procedure (up to 1 hour) minus volume measured at the beginning of the initial procedure. Volume is measured using the standard geometric formula 4/3 πr³ where r is half the long axis. The volume unit is cc.

Group	Value	95% CI
19G Flex Needle	16	± 38
22G Needle	13	± 35
19G Needle	22	± 79

Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL Secondary · Procedure (up to 1 hour)

Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration (final cyst maximal diameter of less than 5mm) or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) (sample volume of 3 cc or more)

Group	Value	95% CI
19G Flex Needle	108
22G Needle	53
19G Needle	48

Number of Participants With PCL Reached/Penetrated Secondary · Procedure (Up to 1 hour)

Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles.

Group	Value	95% CI
19G Flex Needle	114
22G Needle	62
19G Needle	53

Number of EUS-FNA Needle Passes at Initial Procedure. Secondary · Procedure (Up to 1 hour)

Needle pass defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.

Group	Value	95% CI
19G Flex Needle	1	± 0
22G Needle	1	± 0
19G Needle	1	± 0

Number of EUS-FNA Needles Used at Initial Procedure. Secondary · Procedure (Up to 1 hour)

Total number of EUS-FNA needles used across all participants at the initial procedure.

Group	Value	95% CI
19G Flex Needle	156
22G Needle	81
19G Needle	78

Time Needed for Aspiration for Each Needle Pass at Initial Procedure. Secondary · Procedure (Up to 1 hour)

Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of needle pass in is time of the first needle puncture into the cyst lumen. Needle pass out is time of removal of needle outside the cyst lumen, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.

Group	Value	95% CI
19G Flex Needle	86	± 115
22G Needle	145	± 188
19G Needle	106	± 163

Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure. Secondary · Procedure (Up to 1 hour)

Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of first needle pass in is time of the first needle puncture into the cyst lumen. Time of last needle pass out is time of removal of needle outside the cyst lumen at the end of the last fluid aspiration from a single or multi-loculated cyst, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.

Group	Value	95% CI
19G Flex Needle	210	± 225
22G Needle	198	± 161
19G Needle	238	± 205

Number of Needles With Needle Insertion Rated as Excellent/Very Good Secondary · Procedure (Up to 1 hour)

Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure.

Group	Value	95% CI
19G Flex Needle	89
22G Needle	65
19G Needle	31

Number of Needles With Needle Removal Rated as Excellent/Very Good Secondary · Procedure (Up to 1 hour)

Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure.

Group	Value	95% CI
19G Flex Needle	108
22G Needle	67
19G Needle	47

Number of Needles With Needle Visualization Rated as Excellent/Very Good Secondary · Procedure (Up to 1 hour)

Number of needles rated either Excellent or Very good for visualization at the initial procedure.

Group	Value	95% CI
19G Flex Needle	98
22G Needle	61
19G Needle	50

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

19G Flex Needle

Serious: 3/121 (2%)

Deaths: 1/121

22G Needle

Serious: 2/65 (3%)

Deaths: 1/65

19G Needle

Serious: 0/64 (0%)

Deaths: 0/64

Serious adverse events (5 terms)

Reaction	System	19G Flex Needle	22G Needle	19G Needle
Pancreatitis acute	Gastrointestinal disorders	—	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—
Gastroenteritis	Infections and infestations	—	—	—
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	19G Flex Needle	22G Needle	19G Needle
Haemorrhagic cyst	General disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Pancreatitis acute, Pneumonia aspiration, Gastroenteritis, Endometrial cancer metastatic, Neuroendocrine carcinoma metastatic.

Data from ClinicalTrials.gov NCT01711294 adverse events section.

Sponsor's own description

To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.