Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas

NCT01563133 | Unknown

• 1 other identifier: MKT-2012-nCLE-02
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 3

Brief Summary

This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses. On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed. The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes.

• Ruling out malignancy for patients with benign appearing nCLE images.
• Characterizing more malignant tumors in the pancreas.
• Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.

Conditions

Pancreatic Cyst; Pancreatic Neoplasms; Pancreatic Adenoma; Pancreatic Cancer; Pancreatic Islet Cell Tumors; Lymph Node; Lymphadenopathy

Keywords

endomicroscopy; needle-based; pancreatic; cyst; mass; EUSFNA

Outcome Measures

Primary Outcomes (2)

• Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts

  Within 6 months after the end of Follow-up period

• Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes

  Within one year after the end of the follow-up period

Secondary Outcomes (5)

• Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst

  Within one year after the end of the follow-up period

• Validation of the interpretation criteria classification for pancreatic cysts

  within 6 months after the end of the follow-up period

• Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA

  within 3 months of the end of the follow-up period

• Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information

  within one year after the end of the follow-up period

• Feasibility and safety data on nCLE during EUS-FNA procedure

  Within 3 months after the end of the enrollment period

Study Arms (1)

Lymph nodes, pancreatic masses & cysts

OTHER

Procedure: EUS-FNA; Device: nCLE

Interventions

EUS-FNA PROCEDURE

Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle

Also known as: ultrasonographic endoscopy, EUS-guided FNA

Lymph nodes, pancreatic masses & cysts

nCLE DEVICE

needle-based Confocal Laser Endomicroscopy

Lymph nodes, pancreatic masses & cysts

Eligibility Criteria

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

You may qualify if:

• Male or female \> 18 years of age.
• Patient indicated for a first EUS-FNA for a pancreatic cyst, lymph node or pancreatic mass, or
• Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst, lymph nodes, pancreatic mass, more than three months ago.
• Patient with known pancreatic cyst or mass detected at cross-sectional imaging or suspicious lymph nodes reachable via EUSFNA
• Willing and able to comply with study procedures and provide written informed consent to participate in the study.
• Add for lymph nodes:
• \- any lymph node reachable with EUS-FNA
• Add for pancreatic mass:
• any size
• any location in the pancreas

You may not qualify if:

• Subjects for whom EUS-FNA procedures are contraindicated
• Known allergy to fluorescein dye
• If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
• Add for cysts:
• Subject with multiple cysts
• size \< 20mm in diameter
• previous EUS-FNA procedure performed less than 3 months ago - Patients suffering chronic calcifying pancreatitis
• Add for lymph nodes:
• size \< 5mm in diameter
• If patients present several suspicious lymph nodes, only one of them will be imaged during the nCLE procedure
• Add for pancreatic mass:
• \- If patient present several pancreatic masses, only one of them will be imaged during the nCLE procedure

Sponsors & Collaborators

• Mauna Kea Technologies: lead

Study Sites (3)

Hôpital Saint-Philibert

Lomme, 59462, France

Location

Hôpital Jean Mermoz

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Related Publications (22)

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  PMID: 17957438 BACKGROUND

• Levy MJ, Clain JE. Evaluation and management of cystic pancreatic tumors: emphasis on the role of EUS FNA. Clin Gastroenterol Hepatol. 2004 Aug;2(8):639-53. doi: 10.1016/s1542-3565(04)00235-6.

  PMID: 15290655 BACKGROUND

• Hutchins GF, Draganov PV. Cystic neoplasms of the pancreas: a diagnostic challenge. World J Gastroenterol. 2009 Jan 7;15(1):48-54. doi: 10.3748/wjg.15.48.

  PMID: 19115467 BACKGROUND

• Attasaranya S, Pais S, LeBlanc J, McHenry L, Sherman S, DeWitt JM. Endoscopic ultrasound-guided fine needle aspiration and cyst fluid analysis for pancreatic cysts. JOP. 2007 Sep 7;8(5):553-63.

  PMID: 17873459 BACKGROUND

• Becker V, Vercauteren T, von Weyhern CH, Prinz C, Schmid RM, Meining A. High-resolution miniprobe-based confocal microscopy in combination with video mosaicing (with video). Gastrointest Endosc. 2007 Nov;66(5):1001-7. doi: 10.1016/j.gie.2007.04.015. Epub 2007 Sep 4.

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• Meining A, Saur D, Bajbouj M, Becker V, Peltier E, Hofler H, von Weyhern CH, Schmid RM, Prinz C. In vivo histopathology for detection of gastrointestinal neoplasia with a portable, confocal miniprobe: an examiner blinded analysis. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1261-7. doi: 10.1016/j.cgh.2007.05.019. Epub 2007 Aug 6.

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• Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.

  PMID: 16843068 BACKGROUND

• Pohl H, Rosch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28.

  PMID: 18755886 BACKGROUND

• Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10.

  PMID: 19909747 BACKGROUND

• Meining A, Frimberger E, Becker V, Von Delius S, Von Weyhern CH, Schmid RM, Prinz C. Detection of cholangiocarcinoma in vivo using miniprobe-based confocal fluorescence microscopy. Clin Gastroenterol Hepatol. 2008 Sep;6(9):1057-60. doi: 10.1016/j.cgh.2008.04.014. Epub 2008 Jul 17.

  PMID: 18639496 BACKGROUND

• Meining A, Phillip V, Gaa J, Prinz C, Schmid RM. Pancreaticoscopy with miniprobe-based confocal laser-scanning microscopy of an intraductal papillary mucinous neoplasm (with video). Gastrointest Endosc. 2009 May;69(6):1178-80. doi: 10.1016/j.gie.2008.06.013. Epub 2009 Jan 18. No abstract available.

  PMID: 19152895 BACKGROUND

• Konda VJ, Aslanian HR, Wallace MB, Siddiqui UD, Hart J, Waxman I. First assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of the pancreas (with videos). Gastrointest Endosc. 2011 Nov;74(5):1049-60. doi: 10.1016/j.gie.2011.07.018. Epub 2011 Sep 15.

  PMID: 21924718 BACKGROUND

• Giovannini, M., Monges, G.M., Caillol,F., Bories, E., Pesenti C. Feasibility of Intra-Tumoral Confocal Microscopy Under EUS Guidance (EUS-CM)

  BACKGROUND

• Wallace MB, Meining A, Canto MI, Fockens P, Miehlke S, Roesch T, Lightdale CJ, Pohl H, Carr-Locke D, Lohr M, Coron E, Filoche B, Giovannini M, Moreau J, Schmidt C, Kiesslich R. The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract. Aliment Pharmacol Ther. 2010 Mar;31(5):548-52. doi: 10.1111/j.1365-2036.2009.04207.x. Epub 2009 Nov 30.

  PMID: 20002025 BACKGROUND

• Becker V, Wallace MB, Fockens P, von Delius S, Woodward TA, Raimondo M, Voermans RP, Meining A. Needle-based confocal endomicroscopy for in vivo histology of intra-abdominal organs: first results in a porcine model (with videos). Gastrointest Endosc. 2010 Jun;71(7):1260-6. doi: 10.1016/j.gie.2010.01.010. Epub 2010 Apr 24.

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• Khalid A, Brugge W. ACG practice guidelines for the diagnosis and management of neoplastic pancreatic cysts. Am J Gastroenterol. 2007 Oct;102(10):2339-49. doi: 10.1111/j.1572-0241.2007.01516.x. Epub 2007 Aug 31.

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• Bhutani MS. Role of endoscopic ultrasonography in the diagnosis and treatment of cystic tumors of the pancreas. JOP. 2004 Jul;5(4):266-72.

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• Palazzo M, Sauvanet A, Gincul R, Borbath I, Vanbiervliet G, Bourdariat R, Lemaistre AI, Pujol B, Caillol F, Palazzo L, Aubert A, Maire F, Buscail L, Giovannini M, Marque S, Napoleon B. Impact of needle-based confocal laser endomicroscopy on the therapeutic management of single pancreatic cystic lesions. Surg Endosc. 2020 Jun;34(6):2532-2540. doi: 10.1007/s00464-019-07062-9. Epub 2019 Aug 13.

  PMID: 31410626 DERIVED

• Napoleon B, Palazzo M, Lemaistre AI, Caillol F, Palazzo L, Aubert A, Buscail L, Maire F, Morellon BM, Pujol B, Giovannini M. Needle-based confocal laser endomicroscopy of pancreatic cystic lesions: a prospective multicenter validation study in patients with definite diagnosis. Endoscopy. 2019 Sep;51(9):825-835. doi: 10.1055/a-0732-5356. Epub 2018 Oct 22.

  PMID: 30347425 DERIVED

• Giovannini M, Caillol F, Monges G, Poizat F, Lemaistre AI, Pujol B, Lucidarme D, Palazzo L, Napoleon B. Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy in solid pancreatic masses. Endoscopy. 2016 Oct;48(10):892-8. doi: 10.1055/s-0042-112573. Epub 2016 Aug 30.

  PMID: 27576181 DERIVED

• Napoleon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme D, Bourdariat R, Morellon-Mialhe B, Fumex F, Lefort C, Lepilliez V, Palazzo L, Monges G, Filoche B, Giovannini M. A novel approach to the diagnosis of pancreatic serous cystadenoma: needle-based confocal laser endomicroscopy. Endoscopy. 2015 Jan;47(1):26-32. doi: 10.1055/s-0034-1390693. Epub 2014 Oct 17.

  PMID: 25325684 DERIVED

MeSH Terms

Conditions

Pancreatic Cyst; Pancreatic Neoplasms; Pancreatic adenoma; Adenoma, Islet Cell; Lymphadenopathy; Cysts; Arachnodactyly

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Neoplasms; Pancreatic Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Marc Giovannini, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: June 1, 2012
• Primary Completion: March 2, 2016
• Study Completion: March 1, 2019
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

FR (3)