Clinical trial NCT04164017: Impact of Suction in the EUS-guided Fine Needle Biopsy of Solid Pancreatic Lesions
Official title: Comparative Evaluation of the Diagnostic Yield and Sample Quality in Endoscopic Ultrasound(EUS)-Guided Fine Needle Biopsy(FNB) of Pancreatic Solid Lesions With and Without Syringe Suction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biopsy, Fine-Needle
Endosonography
Pancreatic Neoplasm
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Tissue acquisition by Endoscopic Ultrasound (EUS) has become a modality of diagnosis and clinical orientation for several diseases. Although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/FNA), the importance of obtaining a core for histological examination (by fine-needle biopsy/FNB) has recently been recognized.

Currently, there is no clear establishment of the usefulness of syringe suction for the diagnostic accuracy of solid pancreatic lesions when FNB is used.

Because of that, the investigators aimed to compare sensitivity, sample adequacy, and diagnostic yield of solid pancreatic lesions EUS-guided sampling using with and without syringe suction.

The study will be conducted on a consecutive sample of patients proposed to perform EUS for solid pancreatic lesions characterization, in which the clinical and imaging findings justify the need for an FNB.

For each case, FNB will be performed using two punctures: one with 20mL syringe suction, and another without suction. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.

Clinical care during and after the procedure will follow the existing guidelines.

Participants will undergo a single clinical evaluation (at the time of endoscopy and recovery) without the need for follow-up visits.


Eligibility criteria: Inclusion Criteria:

* Patients with 18 years of age and older;
* Ability to provide free and informed consent before entering the study;
* Imaging diagnosis of a solid pancreatic lesion that was proposed for EUS characterization;
* Presence of sectional imaging method (CT/MRI) performed within six months before randomization;
* Blood test (blood count and coagulation studies) compatible with the performance of invasive maneuvers;
* Clinical indication by the endoscopist for EUS-tissue acquisition with the use of an FNB needle.

Exclusion Criteria:

* Failure to provide free and informed consent;
* Clinically significant change in haemostasis laboratory parameters: International Normalized Ratio (INR) \> 1.5; activated partial thromboplastin time (aPTT)\> 50 seconds; Platelets \<50,000;
* Absence of a proper anticoagulant and/or anti-aggregate therapy discontinuation for the performance of FNB;
* Absence of fasting (2h without clear liquids and 6h without solid foods);
* Clinical suspicion of upper digestive tract obstruction;
* An episode of acute pancreatitis within four weeks before echoendoscopy;
* Respiratory failure or hemodynamic instability;
* Pregnancy or breast-feeding.

Primary outcomes:
measure: Diagnostic Yield
timeFrame: Through study completion, an average of 10 months
measure: Accuracy
timeFrame: Through study completion, an average of 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar São João
Study officials:
References:
citation: Wani S, Muthusamy VR, McGrath CM, Sepulveda AR, Das A, Messersmith W, Kochman ML, Shah J. AGA White Paper: Optimizing Endoscopic Ultrasound-Guided Tissue Acquisition and Future Directions. Clin Gastroenterol Hepatol. 2018 Mar;16(3):318-327. doi: 10.1016/j.cgh.2017.10.020. Epub 2017 Oct 23. No abstract available.
citation: Wani S, Muthusamy VR, Komanduri S. EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc. 2014 Dec;80(6):939-59.e7. doi: 10.1016/j.gie.2014.07.066. No abstract available.
citation: Dwyer J, Pantanowitz L, Ohori NP, Pai RK, Vrbin C, Brand RE, Monaco SE. Endoscopic ultrasound-guided FNA and ProCore biopsy in sampling pancreatic and intra-abdominal masses. Cancer Cytopathol. 2016 Feb;124(2):110-21. doi: 10.1002/cncy.21623. Epub 2015 Oct 2.
citation: Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.
citation: Wallace MB, Kennedy T, Durkalski V, Eloubeidi MA, Etamad R, Matsuda K, Lewin D, Van Velse A, Hennesey W, Hawes RH, Hoffman BJ. Randomized controlled trial of EUS-guided fine needle aspiration techniques for the detection of malignant lymphadenopathy. Gastrointest Endosc. 2001 Oct;54(4):441-7. doi: 10.1067/mge.2001.117764.