Different Suction Techniques For Endoscopic Ultrasound-Guided Fine-Needle Biopsy In Pancreatic Solid Lesions

NCT03849209 | Completed

• 1 other identifier: 1270
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided fine-needle aspiration represents the gold-standard for the pathological diagnosis of solid pancreatic lesions. New needles design allowed to obtain samples suitable for histological evaluation (endoscopic ultrasound-guided fine needle biopsy). the aim was to compare two different techniques during ultrasound-guided fine needle biopsy, for diagnosis of suspect pancreatic solid lesions.

Conditions

Pancreatic Solid Lesions

Keywords

Pancreatic Solid Lesions; Fine-Needle Biopsy; Stylet Slow-Pull Technique; Standard Suction; Endoscopic Ultrasound

Outcome Measures

Primary Outcomes (2)

• Degree of blood contamination of samples after endoscopic ultrasound-guided fine needle biopsy of pancreatic mass

  Blood contamination of the specimen was considered significant (large amount of blood cells made pathological diagnosis difficult) or not-significant (no/few blood cells without influence on the pathological diagnosis) based on the pathologist evaluation of the formalin fixed and paraffin embedded (FFPE) tissue samples

  7 days

• Diagnostic accuracy of samples obtained after endoscopic ultrasound-guided fine needle biopsy of pancreatic mass

  Diagnostic accuracy was defined as the ratio between the sum of true positive and true negative values divided by the total number of masses. Sensitivity was defined as the true positive rate whereby the test was the final cytologic diagnosis. Specificity, positive predictive value (PPV), negative predictive value (NPV) were also evaluated.

  up to 6 months

Secondary Outcomes (1)

• Technical success of the procedure after endoscopic ultrasound-guided fine needle biopsy of pancreatic mass

  5 minutes

Study Arms (2)

Stylet Slow-Pull Technique group

EXPERIMENTAL

In patients randomized to the stylet slow-pull techniques an endoscopic ultrasound-guided fine needle biopsy of the pancreatic mass were made with a 20 Gauge needle (EchoTip ProCore 20G with ReCoil Stylet™, Cook Medical, Bloomington, IN, USA): 15 to-and-fro movements within the lesion were performed, with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.

Device: Stylet slow-pull technique

Standard Suction Technique group

ACTIVE COMPARATOR

In patients randomized to the standard suction technique an endoscopic ultrasound-guided fine needle biopsy of the pancreatic mass were made with a 20 Gauge needle (EchoTip ProCore 20G with ReCoil Stylet™, Cook Medical, Bloomington, IN, USA): 15 to-and-fro movements within the lesion were performed with the use of a 10-mL suction syringe.

Device: Standard suction technique

Interventions

Stylet slow-pull technique DEVICE

During endosonographic examination, the pancreatic mass was evaluated with color Doppler to avoid the involvement of vessels. The needle (20 Gauge, EchoTip ProCore 20G with ReCoil Stylet™, Cook Medical, Bloomington, IN, USA) was sharpened by withdrawing the stylet approximately 2 mm, and then was advanced into the lesion: 15 to-and-fro movements within the lesion were performed, with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.

Also known as: Endoscopic ultrasound-guided fine needle biopsy of pancreas

Stylet Slow-Pull Technique group

Standard suction technique DEVICE

During endosonographic examination, the pancreatic mass was evaluated with color Doppler to avoid the involvement of vessels. The needle (20 Gauge, EchoTip ProCore 20G with ReCoil Stylet™, Cook Medical, Bloomington, IN, USA) was sharpened by withdrawing the stylet approximately 2 mm, and then was advanced into the lesion: 15 to-and-fro movements within the lesion were performed using a 10-mL suction syringe.

Also known as: Endoscopic ultrasound-guided fine needle biopsy of pancreas

Standard Suction Technique group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18years old
• Solid pancreatic lesion on imaging MRI and/or CT-scan referred for tissue acquisition
• Lesion can be visualized with EUS and needle puncturing can be technically feasible
• Able to sign informed consent

You may not qualify if:

• \< 18 years-old
• Cystic pancreatic lesions
• Extra-pancreatic lesions or inaccessible/non-visualized lesions
• Previous gastrectomy
• International normalized ratio \> 1.5
• Impossibility to suspend anticoagulant therapy
• Platelet count \< 50.000 cells/cubic millimeter
• Severe or unstable clinical conditions
• Pregnancy
• Inability to give informed consent
• Refusal to participate to the study

Sponsors & Collaborators

• ARNAS Civico Di Cristina Benfratelli Hospital: lead

Study Sites (1)

ARNAS Civico - Di Cristina - Benfratelli Hospital

Palermo, 90127, Italy

Location

Study Officials

• Roberto Di Mitri

  ARNAS Civico Di Cristina Benfratelli Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization was performed using random sequences generated by a computer and then closed in consecutive numbered envelopes.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Gastroenterology and Endoscopy Unit

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: February 21, 2019
• Study Start: May 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

IT (1)