Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions

NCT04843956 | Unknown

• 1 other identifier: GA19-00014
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with a diagnosis of solid pancreatic lesions evidenced by imaging studies (CT, MRI) and who undergo endoscopic ultrasound-guided biopsy will be selected. Biopsies will be taken using modified tip needles (FNB) three different methods (capillary by suction, capillary without suction and wet suction). From the results obtained from the pathology service, 3 variables will be assessed; Cellularity, blood contamination and suitability for a diagnosis.

Conditions

Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• Quality of the sample in relation to the technique

  Establish if there is a difference in the quality of the sample in relation to the technique used to obtain it

  18 months

Secondary Outcomes (1)

• Sample contamination relative to technique

  18 months

Study Arms (1)

Patients with solid pancreatic lesions

EXPERIMENTAL

Patients who will undergo endoscopic ultrasound biopsy. Samples of at least 3 passes will be obtained, each pass obtained with a different technique (capillary with suction, capillary without suction and wet suction)

Diagnostic Test: Endoscopic ultrasound-guided biopsy

Interventions

Endoscopic ultrasound-guided biopsy DIAGNOSTIC_TEST

Capillary with suction (puncture with gradual withdrawal of the stylet, applying dry suction with a 10 ml air vacuum syringe after removing the stylet) Capillary without suction (puncture with removal of the stylet gradually, without suction after removing the stylet) wet suction (Prior to puncture, the stylet is removed from the needle and irrigated with 1-2 ml saline solution to replace the air column with liquid, then the solid lesion is punctured and suction is placed with a 10 ml vacuum syringe of air)

Also known as: Pancreatic biopsy

Patients with solid pancreatic lesions

Eligibility Criteria

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

You may qualify if:

• Over 18 years old
• Any gender.
• Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.

You may not qualify if:

• That no lesion in the pancreas is identified by EUS.
• Pancreatic lesions with a cystic component.
• Alteration of coagulation parameters (INR\> 1.5, Platelets \<50,000 / mm3) or having taken antiplatelet agents or oral anticoagulants one week prior to the biopsy.
• History of acute pancreatitis in the last 4 weeks.
• Pregnant
• Refusal or inability to sign informed consent

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Héctor Miguel Delgado Cortes

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (10)

• Lee YN, Moon JH, Kim HK, Choi HJ, Choi MH, Kim DC, Lee TH, Cha SW, Cho YD, Park SH. Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study. Endoscopy. 2014 Dec;46(12):1056-62. doi: 10.1055/s-0034-1377558. Epub 2014 Aug 6.

  PMID: 25098611 BACKGROUND

• Crino SF, Manfrin E, Scarpa A, Baldaque-Silva F, Carrara S, De Nucci G, Di Mitri R, Gines A, Iglesias-Garcia J, Itoi T, Kitano M, Nguyen NQ, Deprez PH, Poley JW, Shami VM, Tarantino I, Larghi A. EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial. Dig Liver Dis. 2019 Jun;51(6):901-906. doi: 10.1016/j.dld.2019.03.008. Epub 2019 Apr 8.

  PMID: 30975612 BACKGROUND

• Bor R, Vasas B, Fabian A, Balint A, Farkas K, Milassin A, Czako L, Rutka M, Molnar T, Szucs M, Tiszlavicz L, Kaizer L, Hamar S, Szepes Z. Prospective comparison of slow-pull and standard suction techniques of endoscopic ultrasound-guided fine needle aspiration in the diagnosis of solid pancreatic cancer. BMC Gastroenterol. 2019 Jan 9;19(1):6. doi: 10.1186/s12876-018-0921-9.

  PMID: 30626331 BACKGROUND

• Aadam AA, Oh YS, Shidham VB, Khan A, Hunt B, Rao N, Zhang Y, Tarima S, Dua KS. Eliminating the Residual Negative Pressure in the Endoscopic Ultrasound Aspirating Needle Enhances Cytology Yield of Pancreas Masses. Dig Dis Sci. 2016 Mar;61(3):890-9. doi: 10.1007/s10620-015-3860-0. Epub 2015 Sep 7.

  PMID: 26346997 BACKGROUND

• 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.

  PMID: 23433878 BACKGROUND

• Kudo T, Kawakami H, Hayashi T, Yasuda I, Mukai T, Inoue H, Katanuma A, Kawakubo K, Ishiwatari H, Doi S, Yamada R, Maguchi H, Isayama H, Mitsuhashi T, Sakamoto N; Japan EUS-FNA Negative Pressure Suction Study Group. High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2014 Dec;80(6):1030-7.e1. doi: 10.1016/j.gie.2014.04.012. Epub 2014 Jun 2.

  PMID: 24890422 BACKGROUND

• Bansal RK, Choudhary NS, Puri R, Patle SK, Bhagat S, Nasa M, Bhasin A, Sarin H, Guleria M, Sud R. Comparison of endoscopic ultrasound-guided fine-needle aspiration by capillary action, suction, and no suction methods: a randomized blinded study. Endosc Int Open. 2017 Oct;5(10):E980-E984. doi: 10.1055/s-0043-116383. Epub 2017 Oct 4.

  PMID: 28983505 BACKGROUND

• Li H, Li W, Zhou QY, Fan B. Fine needle biopsy is superior to fine needle aspiration in endoscopic ultrasound guided sampling of pancreatic masses: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Mar;97(13):e0207. doi: 10.1097/MD.0000000000010207.

  PMID: 29595661 BACKGROUND

• Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.

  PMID: 28898917 BACKGROUND

• Ge PS, Wani S, Watson RR, Sedarat A, Kim S, Marshall C, Wilson RH, Makker J, Mohamadnejad M, Komanduri S, Muthusamy VR. Per-Pass Performance Characteristics of Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Malignant Solid Pancreatic Masses in a Large Multicenter Cohort. Pancreas. 2018 Mar;47(3):296-301. doi: 10.1097/MPA.0000000000001003.

  PMID: 29401169 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Hector Miguel Delgado Cortes, M.D

CONTACT

+524423395099; hectorm.delgado@gmail.com

Joel Omar Jaquez Quintana

CONTACT

+528114183484; jomjaqui@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The samples will be analyzed independently by the pathology service, not knowing the order and the technique in which the samples were obtained. The histopathological result will be immediately available for patient care, however, the score obtained regarding the quality of the sample will correlate with the technique and the number of passes until the n of the study is completed.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical profesor

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 14, 2021
• Study Start: January 8, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)