Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study

NCT06614452 | Recruiting FDA Device

• 1 other identifier: EUS-FNB biliary strictures
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

After the disappointing results of first-generation reverse bevel fine-needle biopsy (FNB) needles, newer 'third generation' endoscopic ultrasound (EUS) needles were developed, known as the "end-cutting" needles. These needle types have shown excellent diagnostic accuracy (\>90%) in pancreatic masses and several other lesions, even without rapid on site evaluation (ROSE) and are not associated with increased adverse event incidence . The main design of end-cutting FNB needles are the Franseen type, which has three symmetrically distributed needle points and cutting edges, and the Fork-tip type which has 2 protruding asymmetrical sharp points and six distal cutting edges; however, other end-cutting needles are currently available such as the three-prong asymmetric tip needle and the Menghini tip needle. Given the significant increase in diagnostic accuracy and sensitivity observed in other abdominal lesions, these needles are expected to improve the diagnostic outcomes of EUS-FNB of "pure" biliary strictures although clinical data are still lacking. The aim of this study is to ascertain the impact of end-cutting FNB needles in the diagnostic algorithm of biliary strictures in absence of a clear pancreatic or abdominal mass. This is a multicenter international observational prospective study. Consecutive patients diagnosed with biliary strictures in absence of a pancreatic or abdominal mass will be assessed for eligibility. Patients with jaundice requiring decompression, will undergo endoscopic retrograde cholangiopancreatography (ERCP) with tissue sampling (brushing and/or biopsy) and biliary drainage, preferably in the same session immediately after EUS-FNB. Endoscopic ultrasound will be performed using a curvilinear array echoendoscope. FNB with 22G or 25G end-cutting needles will be performed. The size of the needles will be based on the personal choice of the endoscopist. Likewise, the sampling technique, whether using the "slow-pull", the "dry suction", or the "wet suction", will be based on the physician's choice. Three passes will be performed as per current guidelines. Specimens will be collected in 3 vials to allow for analysis according to needle pass; one for the first pass, one for the second pass, and one for the third and any eventual subsequent passes. The ROSE will not be available in this study. Primary outcome will be diagnostic sensitivity of EUS-FNB and 45 patients will be prospectically enrolled.

Conditions

Biliary Strictures

Keywords

biliary strictures; EUS-FNB; Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic sensitivity

  It will be defined as true positives/true positives + false negatives.

  From enrollment to surgery for patients who will undergo surgery or to 6 months of follow-up for patients who will not undergo surgery

Secondary Outcomes (3)

• Sample adequacy

  1 week (from patient enrollment to the pathologic examination of the specimen)

• Diagnostic accuracy

  From enrollment to surgery for patients who will undergo surgery or to 6 months of follow-up for patients who will not undergo surgery

• Adverse event rate

  From patient enrollment to 2 weeks

Study Arms (1)

EUS-FNB

EXPERIMENTAL

Consecutive patients diagnosed with biliary strictures in absence of a pancreatic or abdominal mass will be assessed for eligibility. Patients with jaundice requiring decompression, will undergo ERCP with tissue sampling (brushing and/or biopsy) and biliary drainage, preferably in the same session immediately after EUS-FNB.

Device: EUS-FNB

Interventions

EUS-FNB DEVICE

Endoscopic ultrasound will be performed using a curvilinear array echoendoscope. FNB with 22G or 25G end-cutting needles will be performed. The size of the needles will be based on the personal choice of the endoscopist. Likewise, the sampling technique, whether using the "slow-pull", the "dry suction", or the "wet suction", will be based on the physician's choice. Three passes will be performed as per current guidelines. Specimens will be collected in 3 vials to allow for analysis according to needle pass; one for the first pass, one for the second pass, and one for the third and any eventual subsequent passes. The rapid-on site cytological evaluation (ROSE) will not be available in this study.

EUS-FNB

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Suspicious biliary stricture in absence of an abdominal mass at cross-sectional imaging
• Distal and peri-hilar biliary strictures
• Informed consent provided by the patient or the closest relative

You may not qualify if:

• Presence of a pancreatic or abdominal mass structuring the common bile duct
• EUS not feasible
• Known bleeding disorder that cannot be sufficiently corrected with fresh frozen plasma (FFP)
• Use of anticoagulants that cannot be discontinued
• INR \>1.5 or platelet count \<50.000
• Pregnancy

Sponsors & Collaborators

• Ospedali Riuniti di Foggia: lead

Study Sites (2)

Ospedali Riuniti di Foggia

Foggia, FG, 71122, Italy

RECRUITING

Università di Verona

Verona, VR, 37134, Italy

RECRUITING

Related Publications (10)

• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

  PMID: 20189503 RESULT

• 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.

  PMID: 29074447 RESULT

• Fujii-Lau LL, Thosani NC, Al-Haddad M, Acoba J, Wray CJ, Zvavanjanja R, Amateau SK, Buxbaum JL, Calderwood AH, Chalhoub JM, Coelho-Prabhu N, Desai M, Elhanafi SE, Fishman DS, Forbes N, Jamil LH, Jue TL, Kohli DR, Kwon RS, Law JK, Lee JK, Machicado JD, Marya NB, Pawa S, Ruan W, Sawhney MS, Sheth SG, Storm A, Thiruvengadam NR, Qumseya BJ; (ASGE Standards of Practice Committee Chair, 2020-2023). American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: summary and recommendations. Gastrointest Endosc. 2023 Nov;98(5):685-693. doi: 10.1016/j.gie.2023.06.005. Epub 2023 Jun 10.

  PMID: 37307900 RESULT

• Gkolfakis P, Crino SF, Tziatzios G, Ramai D, Papaefthymiou A, Papanikolaou IS, Triantafyllou K, Arvanitakis M, Lisotti A, Fusaroli P, Mangiavillano B, Carrara S, Repici A, Hassan C, Facciorusso A. Comparative diagnostic performance of end-cutting fine-needle biopsy needles for EUS tissue sampling of solid pancreatic masses: a network meta-analysis. Gastrointest Endosc. 2022 Jun;95(6):1067-1077.e15. doi: 10.1016/j.gie.2022.01.019. Epub 2022 Feb 4.

  PMID: 35124072 RESULT

• Carrara S, Rahal D, Khalaf K, Rizkala T, Koleth G, Bonifacio C, Andreozzi M, Mangiavillano B, Auriemma F, Bossi P, Balzarotti M, Facciorusso A, Staiano T, Maldi E, Spadaccini M, Colombo M, Fugazza A, Maselli R, Hassan C, Repici A. Diagnostic accuracy and safety of EUS-guided end-cutting fine-needle biopsy needles for tissue sampling of abdominal and mediastinal lymphadenopathies: a prospective multicenter series. Gastrointest Endosc. 2023 Aug;98(2):191-198. doi: 10.1016/j.gie.2023.03.018. Epub 2023 Mar 27.

  PMID: 36990125 RESULT

• Facciorusso A, Crino SF, Fugazza A, Carrara S, Spadaccini M, Colombo M, Ramai D, Mangiavillano B, Chandan S, Gkolfakis P, Mohan B, Hassan C, Repici A. Comparative diagnostic yield of different endoscopic techniques for tissue sampling of upper gastrointestinal subepithelial lesions: a network meta-analysis. Endoscopy. 2024 Jan;56(1):31-40. doi: 10.1055/a-2156-0063. Epub 2023 Aug 17.

  PMID: 37591258 RESULT

• Raine T, Thomas JP, Brais R, Godfrey E, Carroll NR, Metz AJ. Test performance and predictors of accuracy of endoscopic ultrasound-guided fine-needle aspiration for diagnosing biliary strictures or masses. Endosc Int Open. 2020 Nov;8(11):E1537-E1544. doi: 10.1055/a-1231-4948. Epub 2020 Oct 21.

  PMID: 33140008 RESULT

• Sadeghi A, Mohamadnejad M, Islami F, Keshtkar A, Biglari M, Malekzadeh R, Eloubeidi MA. Diagnostic yield of EUS-guided FNA for malignant biliary stricture: a systematic review and meta-analysis. Gastrointest Endosc. 2016 Feb;83(2):290-8.e1. doi: 10.1016/j.gie.2015.09.024. Epub 2015 Sep 28.

  PMID: 26422979 RESULT

• Navaneethan U, Njei B, Lourdusamy V, Konjeti R, Vargo JJ, Parsi MA. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan;81(1):168-76. doi: 10.1016/j.gie.2014.09.017. Epub 2014 Nov 1.

  PMID: 25440678 RESULT

• Tummala P, Munigala S, Eloubeidi MA, Agarwal B. Patients with obstructive jaundice and biliary stricture +/- mass lesion on imaging: prevalence of malignancy and potential role of EUS-FNA. J Clin Gastroenterol. 2013 Jul;47(6):532-7. doi: 10.1097/MCG.0b013e3182745d9f.

  PMID: 23340062 RESULT

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Antonio Facciorusso, MD PhD

CONTACT

+390881732134; antonio.facciorusso@virgilio.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: September 10, 2024
• Primary Completion: September 20, 2025
• Study Completion: October 20, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

IT (2)