Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies

NCT ID: NCT04404101

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2025-04-30

Brief Summary

Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with fine needle aspiration (EUS-FNA) and sent for fluid analysis and cytology. More recently, the adjunctive use of the through-the-scope micro forceps (Moray micro forceps, US Endoscopy, Mentor, OH) biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. More recently, the adjunctive use of the Moray® through the needle micro forceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.

Detailed Description

Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with FNA (Fine-Needle Aspiration) and sent for fluid analysis (CEA and amylase) and cytology. However, despite use of a cyst fluid carcinoembryonic antigen (CEA) level cutoff of 192 ng/mL and cytology, accuracy of diagnosis for PCLs is poor. As the spectrum ranges from benign to high risk for neoplasm, precise diagnosis is critical. More recently, the adjunctive use of the Moray® through the needle micro forceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. Pancreatic cysts continue to pose a management dilemma for practicing clinicians, especially with the increased use of radiologic imaging modalities identifying incidental pancreatic cystic lesions with higher frequency. This leads to patient anxiety and increased costs due to radiologic surveillance and even surgery. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.

Conditions

Pancreatic Cyst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1). EUS-FNA plus MFB

A 19-G needle plus micro-forceps will be used for FNA plus MFB.

Group Type: ACTIVE_COMPARATOR

1). EUS-FNA plus MFB

Intervention Type: PROCEDURE

The cyst will be punctured using a 19-G EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed and the wall of the cyst biopsied using the micro forceps passed through the 19 G needle under direct EUS visualization. A minimum of 4 cyst wall biopsies will be obtained to procure at least 4 visible tissue fragments. Cyst fluid will be aspirated and sent for CEA and cytology.

2). EUS-FNA Alone

A 19-G needle will be used for FNA alone.

Group Type: ACTIVE_COMPARATOR

2). EUS-FNA Alone

Intervention Type: PROCEDURE

The cyst will be punctured using an EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed, and cyst fluid will be aspirated and sent for CEA, and cytology.

Interventions

1). EUS-FNA plus MFB

The cyst will be punctured using a 19-G EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed and the wall of the cyst biopsied using the micro forceps passed through the 19 G needle under direct EUS visualization. A minimum of 4 cyst wall biopsies will be obtained to procure at least 4 visible tissue fragments. Cyst fluid will be aspirated and sent for CEA and cytology.

Intervention Type: PROCEDURE

2). EUS-FNA Alone

The cyst will be punctured using an EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed, and cyst fluid will be aspirated and sent for CEA, and cytology.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients >18 years old
• Cysts > 20 mm in size deemed appropriate for FNA by the endoscopist, based on clinical presentation, radiologic imaging features, associated solid mass or nodules, and patient anxiety about the diagnosis

Exclusion Criteria

• Age <18 years
• Inability to provide informed consent
• Thrombocytopenia (Platelets < 50,000) or coagulopathy (INR > 1.8)
• Pregnancy
• Post-surgical anatomy where the cyst is not accessible for FNA
• EUS findings suggesting that cyst FNA would be unsafe (e.g. intervening blood vessels)
• EUS appearance suggesting FNA is not indicated (e.g. cyst smaller than prior radiologic imaging, cyst not seen, EUS suggestive of serous cystadenoma)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Endoscopy

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Duloy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of California Irvine

Irvine, California, United States

Site Status: RECRUITING

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status: ENROLLING_BY_INVITATION

Countries

United States

Central Contacts

Anna Duloy, MD

Role: CONTACT

anna.duloy@cuanschutz.edu

+13037248892

Sandra Boimbo

Role: CONTACT

sandra.boimbo@cuanschutz.edu

Facility Contacts

Jason Samarasena, MD

Role: primary

jsamaras@hs.uci.edu

Hailey Maxwell

Role: backup

maxwellh@hs.uci.edu

Sandra Boimbo

Role: primary

sandra.boimbo@cuanschutz.edu

Peter Tiley

Role: backup

peter.tiley@cuanschutz.edu

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25805375 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 23415799 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Mittal C, Obuch JC, Hammad H, Edmundowicz SA, Wani S, Shah RJ, Brauer BC, Attwell AR, Kaplan JB, Wagh MS. Technical feasibility, diagnostic yield, and safety of microforceps biopsies during EUS evaluation of pancreatic cystic lesions (with video). Gastrointest Endosc. 2018 May;87(5):1263-1269. doi: 10.1016/j.gie.2017.12.025. Epub 2018 Jan 6.

Reference Type: BACKGROUND

PMID: 29309781 (View on PubMed)

Zhang ML, Arpin RN, Brugge WR, Forcione DG, Basar O, Pitman MB. Moray micro forceps biopsy improves the diagnosis of specific pancreatic cysts. Cancer Cytopathol. 2018 Jun;126(6):414-420. doi: 10.1002/cncy.21988. Epub 2018 Apr 16.

Reference Type: BACKGROUND

PMID: 29660844 (View on PubMed)

Basar O, Yuksel O, Yang DJ, Samarasena J, Forcione D, DiMaio CJ, Wagh MS, Chang K, Casey B, Fernandez-Del Castillo C, Pitman MB, Brugge WR. Feasibility and safety of microforceps biopsy in the diagnosis of pancreatic cysts. Gastrointest Endosc. 2018 Jul;88(1):79-86. doi: 10.1016/j.gie.2018.02.039. Epub 2018 Mar 3.

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Barresi L, Crino SF, Fabbri C, Attili F, Poley JW, Carrara S, Tarantino I, Bernardoni L, Giovanelli S, Di Leo M, Manfrin E, Tacelli M, Bruno MJ, Traina M, Larghi A. Endoscopic ultrasound-through-the-needle biopsy in pancreatic cystic lesions: A multicenter study. Dig Endosc. 2018 Nov;30(6):760-770. doi: 10.1111/den.13197. Epub 2018 Jul 5.

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

18-1854

Identifier Type: -

Identifier Source: org_study_id