Trial Outcomes & Findings for Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study (NCT NCT02116322)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

30 days

Results posted on

2017-07-24

Participant Flow

Patients were enrolled between 7/18/14 and 2/18/15 in an academic tertiary center

A total of 4 participants were enrolled. However, 3 participants were excluded before being assigned to the study arm because the performing endoscopist didn't find it possible to do the procedure due to the unfavorable size of the mass or technical difficulty.

Participant milestones

Participant milestones
Measure	Pancreatic Mass Patients with pancreatic mass presenting for EUS-FNA EUS-FNA with Corkscrew technique Expect 19 G Flex needle
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pancreatic Mass n=1 Participants Patients with pancreatic mass presenting for EUS-FNA EUS-FNA with Corkscrew technique Expect 19 G Flex needle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	80 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Pancreatic Mass n=1 Participants Patients with pancreatic mass presenting for EUS-FNA EUS-FNA with Corkscrew technique Expect 19 G Flex needle
Number of Participants With Adverse Events as a Measure of Safety	0 participants

SECONDARY outcome

Timeframe: 30 days

Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis.

Outcome measures

Outcome measures
Measure	Pancreatic Mass n=1 Participants Patients with pancreatic mass presenting for EUS-FNA EUS-FNA with Corkscrew technique Expect 19 G Flex needle
Diagnostic Yield of the FNA Using Corkscrew Technique	0 percentage of masses

Adverse Events

Pancreatic Mass

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mouen Khashab

Johns Hopkins Hospital

Phone: 443-287-1960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place