Pancreatic CystCONTACTNCT01563133
Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
A study testing EUS-FNA and nCLE in people with Pancreatic Cyst and Pancreatic Neoplasms, run by Mauna Kea Technologies at 3 sites in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma
- What is being tested?
- EUS-FNA and nCLE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2012to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- any lymph node reachable with EUS-FNA
- Add for pancreatic mass:
- any size
- any location in the pancreas
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Saint-Philibert
Lomme, 59462
Hôpital Jean Mermoz
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13273
About this study
Official title: Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
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.
Read more
The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes.
- Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :
- 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.
Read the detailed description
- Medical background Pancreatic cancer is the fourth leading cause of cancer-related death in the United States. This disease is associated with a high mortality rate: the 5-year survival rate is estimated to be 4%. This is mainly due to the fact that the disease is often discovered at an already advanced disease state, which carries a dismal prognosis. 1.1. Pancreatic Cysts Pancreatic cysts are quite rare, but are being increasingly recognized due to the expanding use of cross-sectional imaging. They are classified into three main classes:
- Pseudocysts
- Serous cysts : either serous cystic neoplasms (SCN) or Solid pseudo-papillary neoplasm (SPN)
- Mucinous cystic neoplasms : either Intraductal Papillary Mucinous Neoplasm (IPMN) or mucinous cystadenomas/mucinous cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or pre-malignant and are considered for surgical resection, whereas pseudocysts and serous cysts are considered benign and with a low potential for malignancy. Pseudocysts and serous cysts are usually only considered for surgical resection when symptomatic or enlarging. 1.2. Pancreatic masses Pancreatic solid masses can be either exocrine or endocrine tumors, or metastatic.Exocrine tumors are by far the most common type of pancreas cancer. Most of them are malignant. About 96% of cancers of the exocrine pancreas are adenocarcinomas, which is the most aggressive form of pancreas cancer.Endocrine tumors are uncommon. They represent 4% of pancreas tumors. They are known as neuroendocrine tumors (NETs), or islet cell tumors. These tumors can be benign or malignant. 1.3. Lymph nodes Lymph nodes are examined in a patient with a suspicion of, or confirmed, cancer, as part of the staging. They may be either normal, inflammatory, or malignant.
- Clinical background 2.1. EUSFNA Endoscopic Ultrasound (EUS) is the diagnostic method of choice when a pancreatic lesion is found incidentally on cross-sectional imaging. Endoscopic UltraSound-guided Fine Needle Aspiration (EUS FNA) (respectively Endobronchial Ultrasound-guided Fine Needle Aspiration (EBUS FNA)) are procedures where a target tissue in proximity to the GI tract (respectively the pulmonary tract) is biopsied using a fine needle guided in real time by an ultrasound probe fixed at the tip of an endoscope.It may therefore be applied to pancreatic lesions, or lymph nodes examination. 2.2. nCLE The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts with a miniprobe inserted through an endoscopic needle. The fundamental technology as well as the principle of operation of nCLE are substantially similar to pCLE.
- Clinical evidence More than 100 patients have already underwent an nCLE procedure, in the past studies. A first feasibility study enabled to define the final type of probe which would fit into a EUSFNA needle, and the INSPECT study enabled to define interpretation criteria on the micro-structure of pancreatic cysts. Less data is available on pancreatic masses and lymph nodes, except for a few images done in the first feasibility study.
- Objectives 4.1. Cysts 4.1.1. The primary objective of the study is to assess the diagnostic performance of the Cellvizio nCLE system in diagnosing pancreatic cysts, when associated with other diagnostic information. 4.1.2. The secondary objectives are to assess the potential impact of the Cellvizio nCLE system on patient management and validate the interpretation classification criteria that were created during the previous INSPECT study on cysts. 4.2. Pancreatic masses and Lymph nodes 4.2.1. The primary objective of the study is to define criteria of nCLE sequences in lymph nodes and pancreatic masses. 4.2.2. The secondary objectives are to evaluate feasibility and safety of the Cellvizio nCLE during EUS-FNA procedures, build an atlas of images of nCLE sequences of pancreatic masses and lymph nodes, and, finally, retrospectively assess the diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information
- Design This study will be conducted in three centers in France.
- Conditions
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer, Pancreatic Islet Cell Tumors, Lymph Node
- Being tested
- EUS-FNA, nCLE
- Keywords
- endomicroscopy, needle-based, pancreatic, cyst, mass, EUSFNA
- Medical subject headings
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic adenoma, Adenoma, Islet Cell, Lymphadenopathy, Cysts, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNAProcedure or surgery
Also called ultrasonographic endoscopy, EUS-guided FNA
Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
nCLEDevice
needle-based Confocal Laser Endomicroscopy
| Study group | Role | What they receive |
|---|---|---|
| Lymph nodes, pancreatic masses & cysts | Other | Not described Receives: Procedure: EUS-FNA; Device: nCLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
Measured: Within 6 months after the end of Follow-up period
Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes
Measured: 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
Measured: Within one year after the end of the follow-up period
Validation of the interpretation criteria classification for pancreatic cysts
Measured: 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
Measured: 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
Measured: within one year after the end of the follow-up period
Feasibility and safety data on nCLE during EUS-FNA procedure
Measured: Within 3 months after the end of the enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJun 2012
- Primary completion2 Mar 2016
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mauna Kea Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Giovannini, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563133
- Sponsor's protocol ID
- MKT-2012-nCLE-02
- Acronym
- CONTACT
- Status last verified
- Aug 2017
- First submitted
- 22 Mar 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Adsay NV. Cystic neoplasia of the pancreas: pathology and biology. J Gastrointest Surg. 2008 Mar;12(3):401-4. doi: 10.1007/s11605-007-0348-z. Epub 2007 Oct 24.
PubMed 17957438Levy 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.
PubMed 15290655Hutchins 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.
PubMed 19115467Attasaranya 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.
PubMed 17873459Becker 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.
PubMed 17767932Meining 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.
PubMed 17689297Kiesslich 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.
PubMed 16843068Pohl 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.
PubMed 18755886Buchner 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.
PubMed 19909747Meining 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.
PubMed 18639496Meining 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.
PubMed 19152895Konda 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.
PubMed 21924718Giovannini, M., Monges, G.M., Caillol,F., Bories, E., Pesenti C. Feasibility of Intra-Tumoral Confocal Microscopy Under EUS Guidance (EUS-CM)
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.
PubMed 20002025Becker 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.
PubMed 20421104
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
- ClinicalTrials.gov ID
- NCT01563133
- Acronym / sponsor ID
- CONTACT / MKT-2012-nCLE-02
- Conditions
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer, Pancreatic Islet Cell Tumors, Lymph Node
- Keywords
- endomicroscopy, needle-based, pancreatic, cyst, mass, EUSFNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Mauna Kea TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- 2 Mar 2016 (actual)
- Study completion
- Mar 2019 (estimated)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :
- 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.
Detailed description
- Medical background Pancreatic cancer is the fourth leading cause of cancer-related death in the United States. This disease is associated with a high mortality rate: the 5-year survival rate is estimated to be 4%. This is mainly due to the fact that the disease is often discovered at an already advanced disease state, which carries a dismal prognosis. 1.1. Pancreatic Cysts Pancreatic cysts are quite rare, but are being increasingly recognized due to the expanding use of cross-sectional imaging. They are classified into three main classes:
- Pseudocysts
- Serous cysts : either serous cystic neoplasms (SCN) or Solid pseudo-papillary neoplasm (SPN)
- Mucinous cystic neoplasms : either Intraductal Papillary Mucinous Neoplasm (IPMN) or mucinous cystadenomas/mucinous cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or pre-malignant and are considered for surgical resection, whereas pseudocysts and serous cysts are considered benign and with a low potential for malignancy. Pseudocysts and serous cysts are usually only considered for surgical resection when symptomatic or enlarging. 1.2. Pancreatic masses Pancreatic solid masses can be either exocrine or endocrine tumors, or metastatic.Exocrine tumors are by far the most common type of pancreas cancer. Most of them are malignant. About 96% of cancers of the exocrine pancreas are adenocarcinomas, which is the most aggressive form of pancreas cancer.Endocrine tumors are uncommon. They represent 4% of pancreas tumors. They are known as neuroendocrine tumors (NETs), or islet cell tumors. These tumors can be benign or malignant. 1.3. Lymph nodes Lymph nodes are examined in a patient with a suspicion of, or confirmed, cancer, as part of the staging. They may be either normal, inflammatory, or malignant.
- Clinical background 2.1. EUSFNA Endoscopic Ultrasound (EUS) is the diagnostic method of choice when a pancreatic lesion is found incidentally on cross-sectional imaging. Endoscopic UltraSound-guided Fine Needle Aspiration (EUS FNA) (respectively Endobronchial Ultrasound-guided Fine Needle Aspiration (EBUS FNA)) are procedures where a target tissue in proximity to the GI tract (respectively the pulmonary tract) is biopsied using a fine needle guided in real time by an ultrasound probe fixed at the tip of an endoscope.It may therefore be applied to pancreatic lesions, or lymph nodes examination. 2.2. nCLE The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts with a miniprobe inserted through an endoscopic needle. The fundamental technology as well as the principle of operation of nCLE are substantially similar to pCLE.
- Clinical evidence More than 100 patients have already underwent an nCLE procedure, in the past studies. A first feasibility study enabled to define the final type of probe which would fit into a EUSFNA needle, and the INSPECT study enabled to define interpretation criteria on the micro-structure of pancreatic cysts. Less data is available on pancreatic masses and lymph nodes, except for a few images done in the first feasibility study.
- Objectives 4.1. Cysts 4.1.1. The primary objective of the study is to assess the diagnostic performance of the Cellvizio nCLE system in diagnosing pancreatic cysts, when associated with other diagnostic information. 4.1.2. The secondary objectives are to assess the potential impact of the Cellvizio nCLE system on patient management and validate the interpretation classification criteria that were created during the previous INSPECT study on cysts. 4.2. Pancreatic masses and Lymph nodes 4.2.1. The primary objective of the study is to define criteria of nCLE sequences in lymph nodes and pancreatic masses. 4.2.2. The secondary objectives are to evaluate feasibility and safety of the Cellvizio nCLE during EUS-FNA procedures, build an atlas of images of nCLE sequences of pancreatic masses and lymph nodes, and, finally, retrospectively assess the diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information
- Design This study will be conducted in three centers in France.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymph nodes, pancreatic masses & cysts | Other | Procedure: EUS-FNA, Device: nCLE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
- Subject with multiple cysts
- size < 20mm in diameter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-FNAAlso: ultrasonographic endoscopy, EUS-guided FNAEndoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle | Procedure or surgery | Lymph nodes, pancreatic masses & cysts |
| nCLEneedle-based Confocal Laser Endomicroscopy | Device | Lymph nodes, pancreatic masses & cysts |
Primary outcome
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
Time frame: Within 6 months after the end of Follow-up period
Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes
Time frame: Within one year after the end of the follow-up period
5 secondary outcomes
Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst
Time frame: Within one year after the end of the follow-up period
Validation of the interpretation criteria classification for pancreatic cysts
Time frame: 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
Time frame: 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
Time frame: within one year after the end of the follow-up period
Feasibility and safety data on nCLE during EUS-FNA procedure
Time frame: Within 3 months after the end of the enrollment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Background: PubMed 17957438Adsay NV. Cystic neoplasia of the pancreas: pathology and biology. J Gastrointest Surg. 2008 Mar;12(3):401-4. doi: 10.1007/s11605-007-0348-z. Epub 2007 Oct 24.
- Background: PubMed 15290655Levy 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.
- Background: PubMed 19115467Hutchins 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.
- Background: PubMed 17873459Attasaranya 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.
- Background: PubMed 17767932Becker 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.
- Background: PubMed 17689297Meining 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.
- Background: PubMed 16843068Kiesslich 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.
- Background: PubMed 18755886Pohl 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.
- Background: PubMed 19909747Buchner 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.
- Background: PubMed 18639496Meining 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.
- Background: PubMed 19152895Meining 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.
- Background: PubMed 21924718Konda 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.
Related trials for Pancreatic Cyst
Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
RecruitingObservational study
Pancreatic Cancer Early Detection Consortium
Pancreas Cancer, Pancreas Cyst
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Recruiting
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Pancreatic Disease, Pancreatic Cancer
RecruitingObservational study
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Pancreatic Cyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Giovannini, MD principal investigator
Institut Paoli-Calmettes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-FNA and nCLE in people with Pancreatic Cyst and Pancreatic Neoplasms, run by Mauna Kea Technologies at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts (time frame: Within 6 months after the end of Follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563133, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.