Needle-based Confocal Endomicroscopy Examination of Pancreatic Masse

NCT01734967 | Completed DMC

• 1 other identifier: herlev
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 2

Brief Summary

Introduction: Pancreatic cancer is one of the most aggressive malignancies with only 5% of patients being alive at five years. EUS (endoscopic ultra sound) is an established, sensitive diagnostic tool in pancreatic cancer and for staging purposes. Additionally, EUS enables guided fine needle aspiration (FNA), which is currently recommended as the first-line procedure whenever a pathological diagnosis is required. However, EUS-FNA as a sampling method has its drawbacks, due to a relatively low negative predictive value. Confocal laser endomicroscopy has emerged in recent years as a novel method that enables in vivo microscopic analysis during ongoing endoscopy. Recently, confocal laser endomicroscopy has gone beyond the superficial luminal indications with the development of a new microprobe, i.e. a flexible laser probe (nCLE) that can pass through a 19-gauge needle. Combined with EUS, descriptive criteria for the diagnosis of pancreatic cystic neoplasm has been developed in a multicentre trial. However, only a limited number of cases of solid pancreatic masses have been described with nCLE. Aim and Method: To describe confocal imaging criteria for pancreatic masses, lymph nodes or liver metastases identified during EUS procedures performed for pancreatic cancer staging (EUS-nCLE), while evaluating also the feasibility and safety of nCLE examination. The hypothesis is that EUS-nCLE could allow targeted tissue sampling of pancreatic lesions resulting in more accurate diagnosis. XX patients were included all presenting with a clinical suspicion of pancreatic cancer or imaging studies showing a pancreatic mass. During the procedure an nCLE preloaded 19G FNA needle was advanced into the lesion under EUS guidance. A contrast agent was administered intravenously (2.5 ml fluorescein 10%). The data was stored digitally for post procedural analysis. Afterwards EUS-FNA was performed for cytology smears to enable a final pathological diagnosis. Correlations between the nCLE images and the conventional pathology were identified.

Conditions

Pancreatic Neoplasms; CHRONIC PANCREATITIS

Keywords

confocal laser endomicroscopy; Pancreatic Neoplasms; CHRONIC PANCREATITIS; Endoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

• Describe confocal imaging criteria for pancreatic masses, lymph nodes or liver metastases

  Tumor characteristics (EUS) (echogenicity, echostructure, size, vascular invasion) will be described. EUS-nCLE will be performed after EUS identification of the pancreatic tumor / lymph node / liver metastasis: Confocal images will be analyzed to correlate representative confocal images and classical hematoxylin and eosin sections. The final diagnosis will be based on EUS-FNA cytology and/or histological specimens in those patients that will be further referred for surgery. For the patients without positive cytology or histology the diagnosis will be based on EUS tumor characteristics and other relevant information (clinical, imaging tests) with follow-up for at least six months The outcome is fully descriptive.

  6 month

Secondary Outcomes (2)

• Safety

  30 days

• Feasibility

  1 day

Study Arms (1)

needle based CLE & EUS-FNA

EXPERIMENTAL

The study will prospectively include patients referred to our department for EUS and EUS-FNA of suspected pancreatic masses during a 12 months period. The indication for this investigation will be based on the patient's clinical history and previous imaging studies (abdominal ultrasound, CT scan, MRI).

Device: needle based CLE; Procedure: EUS-FNA

Interventions

needle based CLE DEVICE

EUS-nCLE will be performed after EUS identification of the pancreatic tumor / lymph node / liver metastasis: The confocal microprobe will be preloaded in a 19G FNA needle as previously described and advanced into the lesion under EUS guidance. nCLE examination will follow after the intravenous administration of the contrast agent (2.5 ml fluorescein 10%). Image data will be stored digitally for offline analysis.

Also known as: nCLE

needle based CLE & EUS-FNA

EUS-FNA PROCEDURE

Endoscopic ultrasound (EUS) is an established tool in pancreatic masses used both for diagnosis, but also for staging purposes. Additionally, EUS enables guided fine needle aspiration (FNA), which is currently recommended as the first-line procedure whenever a pathological diagnosis is required.

Also known as: Endoscopic ultrasound with fine-needle aspiration

needle based CLE & EUS-FNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old, male or female
• Patients diagnosed with solid pancreatic masses with an indication for EUS-FNA
• Signed informed consent for EUS with FNA and nCLE examination

You may not qualify if:

• Failure to provide informed consent
• Patients with a contraindication for EUS-FNA
• Known allergy to fluorescein
• Pregnant or breast-feeding patients

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (2)

Copenhagen University Hospital Herlev

Herlev, 2730, Denmark

Location

Research Center of Gastroenterology and Hepatology,

Craiva, 200349,, Romania

Location

Related Publications (9)

• Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. Lancet. 2011 Aug 13;378(9791):607-20. doi: 10.1016/S0140-6736(10)62307-0. Epub 2011 May 26.

  PMID: 21620466 BACKGROUND

• Sharma C, Eltawil KM, Renfrew PD, Walsh MJ, Molinari M. Advances in diagnosis, treatment and palliation of pancreatic carcinoma: 1990-2010. World J Gastroenterol. 2011 Feb 21;17(7):867-97. doi: 10.3748/wjg.v17.i7.867.

  PMID: 21412497 BACKGROUND

• Saftoiu A, Vilmann P. Role of endoscopic ultrasound in the diagnosis and staging of pancreatic cancer. J Clin Ultrasound. 2009 Jan;37(1):1-17. doi: 10.1002/jcu.20534.

  PMID: 18932265 BACKGROUND

• DeWitt J, Devereaux B, Chriswell M, McGreevy K, Howard T, Imperiale TF, Ciaccia D, Lane KA, Maglinte D, Kopecky K, LeBlanc J, McHenry L, Madura J, Aisen A, Cramer H, Cummings O, Sherman S. Comparison of endoscopic ultrasonography and multidetector computed tomography for detecting and staging pancreatic cancer. Ann Intern Med. 2004 Nov 16;141(10):753-63. doi: 10.7326/0003-4819-141-10-200411160-00006.

  PMID: 15545675 BACKGROUND

• Iglesias Garcia JJ, Larino Noia J, Alvarez Castro A, Cigarran B, Dominguez Munoz JE. Second-generation endoscopic ultrasound elastography in the differential diagnosis of solid pancreatic masses. Pancreatic cancer vs. inflammatory mass in chronic pancreatitis. Rev Esp Enferm Dig. 2009 Oct;101(10):723-30. doi: 10.4321/s1130-01082009001000009. English, Spanish.

  PMID: 19899942 BACKGROUND

• Dumonceau JM, Polkowski M, Larghi A, Vilmann P, Giovannini M, Frossard JL, Heresbach D, Pujol B, Fernandez-Esparrach G, Vazquez-Sequeiros E, Gines A; European Society of Gastrointestinal Endoscopy. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2011 Oct;43(10):897-912. doi: 10.1055/s-0030-1256754. Epub 2011 Aug 12.

  PMID: 21842456 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.

  PMID: 20421104 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

• Karstensen JG, Cartana T, Klausen PH, Hassan H, Popescu CF, Saftoiu A, Vilmann P. Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy: a pilot study for use in focal pancreatic masses. Pancreas. 2015 Jul;44(5):833-5. doi: 10.1097/MPA.0000000000000345. No abstract available.

  PMID: 26061561 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis, Chronic

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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; Punctures

Study Officials

• john G Karstensen, M.D.

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

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: M.D.

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

RO (1); DK (1)