Pancreas NeoplasmsEMIDNCT00930410
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
A study testing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) in people with Pancreas Neoplasms and Bile Duct Diseases, run by Institut Paoli-Calmettes at 2 sites in 2 countries.
Trial summary
The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasms, Bile Duct Diseases
- What is being tested?
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2008to May 2012
- 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
- Patients aged from 18 to older
- Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal.
- Signed consent
- Non inclusion Criteria:
- Patient who have no indication for an ERCP
- Allergy to fluorescein
Show all 12Show fewer
- Allergic rhinitis, asthma, eczema
- Pregnancy, breast feeding
- Patients with dialysis
- Patient with severe heart failure
- Patient with cirrhosis
- Hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.
Read the detailed description
Primary objective:
Obtain a tissular characterization of a biliary or pancreatic stenosis with a confocal microscope which is in direct contact of the stenosis during the Endoscopic Retrograde Cholangio-Pancreatography (ERCP).
Secondary objectives:
- Compare the result of this "optical biopsy" to a conventional biopsy.
- Tolerance
- Conditions
- Pancreas Neoplasms, Bile Duct Diseases
- Being tested
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
- Keywords
- pancreas neoplasms, bile duct diseases, Cholangiopancreatography, Endoscopic Retrograde, ERCP
- Medical subject headings
- Pancreatic Neoplasms, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde Cholangio-Pancreatography (ERCP)Procedure or surgery
Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.
| Study group | Role | What they receive |
|---|---|---|
| endomicroscopy | Experimental | Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography Receives: Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology.
Measured: 2 days
Secondary outcomes (2)
Study of the concordance between optical and histological biopsy
Measured: 2 days
Frequency and grade of adverse effects induced by the confocal endomicroscopy
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas NeoplasmsStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc GIOVANNINI, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930410
- Sponsor's protocol ID
- EMID/IPC 2008-001
- Acronym
- EMID
- Status last verified
- Mar 2013
- First submitted
- 27 Jun 2009
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
- ClinicalTrials.gov ID
- NCT00930410
- Acronym / sponsor ID
- EMID / EMID/IPC 2008-001
- Conditions
- Pancreas Neoplasms, Bile Duct Diseases
- Keywords
- pancreas neoplasms, bile duct diseases, Cholangiopancreatography, Endoscopic Retrograde, ERCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Jun 2009 (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.
The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.
Detailed description
Primary objective:
Obtain a tissular characterization of a biliary or pancreatic stenosis with a confocal microscope which is in direct contact of the stenosis during the Endoscopic Retrograde Cholangio-Pancreatography (ERCP).
Secondary objectives:
- Compare the result of this "optical biopsy" to a conventional biopsy.
- Tolerance
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endomicroscopy | Experimental | Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged from 18 to older
- Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal.
- Signed consent
- Patient who have no indication for an ERCP
- Allergy to fluorescein
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Endoscopic Retrograde Cholangio-Pancreatography (ERCP)Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology. | Procedure or surgery | endomicroscopy |
Primary outcome
The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology.
Time frame: 2 days
2 secondary outcomes
Study of the concordance between optical and histological biopsy
Time frame: 2 days
Frequency and grade of adverse effects induced by the confocal endomicroscopy
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Official web site of the sponsorLink provided by the sponsor.
Related trials for Pancreas Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) in people with Pancreas Neoplasms and Bile Duct Diseases, run by Institut Paoli-Calmettes at 2 sites in 2 countries.
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 12 inclusion and 0 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: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Monaco. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2013.