EUS-guided Through-the-needle Microforceps Biopsy Outcomes

NCT04140435 | Unknown

• 1 other identifier: IGEA07-2019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: The diagnosis of pancreatic cystic lesions (PCLs) is increasing due to improvements of cross-sectional imaging. It is mandatory, for appropriate management, to make an accurate diagnosis and risk stratification, since some of these lesions may harbor malignancy or have potential for malignant transformation and hence surgical resection is required. Diagnostic evaluation of PCLs can be challenging, requiring a combination of different methods. Usually PCLs are been initially detected by cross-sectional imaging. However, imaging alone has not been shown to reliably identify the underlying pathology in PCLs with a high degree of accuracy. Hence, Endoscopic ultrasound with fine-needle aspiration (EUS-FNA) is routinely performed. EUS-FNA plays an important role in cyst characterization since allows morphological examination (EUS-B mode), aspiration for cytology and cyst fluid analysis for carcinoembryonic antigen (CEA), amylase and glucose levels; and allows to tissue sample in case of mural nodules o wall thickness. Even though EUS-FNA has been shown to be the test of choice for select lesions with high-risk features, has its limitations related to low sensitivity and specificity. The morphological characterization by EUS of PCL, as well as with the cross-sectional images, depends most of the time, on the subjective interpretation of the operator, which can be very difficult sometimes and depend on experience. A cyst fluid CEA cutoff of 192 ng/mL has been commonly accepted for differentiating mucinous from non-mucinous cysts. However, has the limitation of requiring at least 0.5 mL of cyst fluid for CEA analysis, has a relatively low sensitivity (75%) and specificity (84%), cannot differentiate cyst histotypes, and controversial results have been reported. Finally targeted cyst wall with the tip of the FNA needle can increase the diagnostic accuracy, yet the cytological yield with EUS-FNA remains low due to the relatively small tissue sample. Hence, diagnostic accuracy of currently available tools for evaluation of PCLs including cross-sectional imaging, EUS morphologic features, EUS-FNA for cyst fluid analysis and cytology is not perfect, leading to possible misdiagnosis.

Conditions

Pancreatic Cyst

Keywords

EUS-guided through the needle biopsy (EUS-guided TTNB); Pancreatic cyst lesions (PCLs)

Outcome Measures

Primary Outcomes (1)

• The increment in diagnostic yield

  The diagnostic performance (accuracy) of the device will be compared to standard evaluation accuracy (cross-sectional imaging and EUS-FNA with cyst fluid analysis) and finally corroborated with surgery biopsy and 12 month follow up (gold standard).

  1 year

Secondary Outcomes (4)

• Percentage of technical success

  1 year

• Percentage of clinical success

  1 year

• Percentage of adverse events

  1 year

• The inter-observer agreement

  1 year

Study Arms (1)

TTNB group

Patients with PCLs suitable for biopsy.

Device: EUS-guided through-the-needle microbiopsy forceps (Moray)

Interventions

EUS-guided through-the-needle microbiopsy forceps (Moray) DEVICE

EUS-TTNB procedure technique. An endosonographer of each institution will perform the EUS procedures. Cysts morphology will be recorded and then punctured by using a 19-gauge EUS-FNA needle. Then the through-the-needle microbiopsy forceps (Moray) will be inserted through the needle into the cystic lumen. Microbiopsies will be obtained from the cyst wall randomly and from mural nodules or septae when observed. The open jaws of the forceps will be pushed onto the cyst wall, closed and pulled back to cause visible tenting. Two "bites" per pass will be obtained. Then the forceps will be removed and the specimen placed in formalin vials. The procedure will be repeated 2 times, or until 2 visible specimens are obtained. After completion of biopsies, the cyst fluid will be completely aspirated and sent for CEA, amylase, glucose and cytology analyses. If a mural nodule is visualized on EUS, it will be accessed separately by using the 19-gauge needle for EUS-FNA cytology.

TTNB group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic cysts suitable for EUS TTNB with microforceps.

You may qualify if:

• Aged ≥ 18 years old patients.
• Patints that agree to participate in the study.
• PCLs ≥ 10mm, large enough to accommodate the microforceps.
• Patients with PCLs and high-risk features (cyst \> 3 cm, thickened wall, dilated pancreatic duct, mural nodules and solid component).
• New diagnosis of a PCL or interval changes in morphology on surveillance (cyst growth or high-risk features).
• Patients with PCLs and symptoms (e. g. pancreatitis, abdominal pain, obstructive jaundice).
• Patients with PCLs but without high-risk features and anxiety about the diagnosis.

You may not qualify if:

• Inability to provide informed consent for the procedure.
• Pregnancy.
• Platelet count less than 50,000/ml or International Normalized Rate (INR) \>2.
• Esophageal stricture or any pathology that does noy allows performing EUS.

Sponsors & Collaborators

• Institute of Gastroenterology and Advance Endoscopy: lead

Study Sites (1)

Institute of Gastroenterology and Advanced Endoscopy (IGEA)

Bahía Blanca, Buenos Aires, 8000, Argentina

RECRUITING

Related Publications (16)

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  PMID: 22317883 RESULT

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  PMID: 26643697 RESULT

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  PMID: 15131794 RESULT

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  PMID: 26077458 RESULT

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  PMID: 31100310 RESULT

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  PMID: 30574535 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of cyst wall

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Manuel Valero, MD

  Institute of Gastroenterology and Advanced Endoscopy (IGEA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Valero, MD

CONTACT

(+54) 2914429990; valero.manuel@hotmail.com

Vanesa Salazar, MD

CONTACT

(+54) 2914405802; salazarmoralesvanesa@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 25, 2019
• Study Start: October 22, 2019
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)