All Surgical Conditions Usually Necessitating Frozen SectionPilot pCLENCT02552004
Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study
A study testing pCLE and IV fluorescein administration in people with All Surgical Conditions Usually Necessitating Frozen Section and Malignant Tumor, run by IHU Strasbourg at 1 site in France.
Trial summary
Intraoperative histological examination is a fundamental tool in surgery. Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate pCLE in surgical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All Surgical Conditions Usually Necessitating Frozen Section, Malignant Tumor, Inflammatory Disease
- What is being tested?
- pCLE and IV fluorescein administration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2015to 1 Feb 2018
- 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
- Patient, male or female, over 18 years old
- Patient candidate to digestive or endocrine surgery in whom the surgeon deems necessary intraoperative frozen section
- Patient able to understand the study and to provide informed consent
- Patient affiliated to the French social security system
Who cannot join
- Patient unable to provide informed consent
- Patient with known or suspected allergy to fluorescein
- Patient who had a previous life-threatening reaction during an angiography
- Patient with a history of multiple and severe allergic reactions to medications
- Patient taking a beta-blocker treatment
- Patient with comorbidity considered by the investigator, as incompatible with the procedures of the study
Show all 10Show fewer
- Patient pregnant or breastfeeding
- Patient in exclusion period (determined by a previous study or in progress)
- Patient having forfeited their freedom of an administrative or legal obligation
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil
Strasbourg, 67000
About this study
Official title: Assessment of the Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery - a Pilot Study
Intraoperative histological examination is a fundamental tool in surgery. Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate pCLE in surgical setting. The objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the video sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images. The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.
Read the detailed description
Intraoperative histological examination is a fundamental tool for cancer surgery (extent of surgery, resection margins, sentinel lymph node) and necessary in other circumstances like redo surgery or endocrine surgery. Using conventional frozen section technique results in the prolongation of operating time of about 40 minutes.
Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging. Specifically, after intravenous injection of a fluorescent contrast agent - in this study fluorescein will be used, the pCLE system provides video sequences of the tissue, using a confocal microscope integrated in a miniprobe and a low power laser as the illumination source (Cellvizio®, Mauna Kea Technologies, Paris, France).
The pCLE is currently used in endoscopy, mainly for the follow-up of Barrett's esophagus, colorectal polyps and strictures of the bile and pancreatic ducts, but also in urology. The pCLE has never been tested in open or video-assisted surgery settings. Sterilizable probes exist and are certified for use via an endoscope in France (UHD CystoFlexTM, AQ-FLEX 19TM Mauna Kea Technologies, Paris, France). A probe (CelioFlex UHDTM) is currently being developed for use in laparoscopic surgery setting.
This pilot study aims to evaluate pCLE in surgical setting. Each anatomical structure corresponds to a specific tissue architecture, which is today known through standard histological examination. Conventional histology implies alteration of the tissue architecture, with ablation of blood supply, sampling and technical treatment of the samples (fixation, cutting, staining). The pCLE enables to bypass this process and allows obtaining images of the microscopic structure in vivo, without cell damage and without interruption of the blood and lymphatic circulation. The obtained video sequences reflect the microscopic architecture, in a form which is to date, neither mapped nor exploited for deep organs. The potential of this technique was demonstrated in intraabdominal organs only in the animal model, with very encouraging results as the sensitivity and specificity of pCLE were superior to standard histological examination.
The primary objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included.
The installation and surgical opening will be performed according to standard protocols. A contrast agent, fluorescein, will be injected intravenously to allow tissue visualization with the pCLE. During the surgery, the surgeon will perform the pCLE examination, to obtain and record video sequences of in situ structures. Frozen sections will be obtained on the same samples and will further guide the surgical decision-making.
Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images.
The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.
A second study, in comparative prospective settings, could further be focused only on the promising conditions in order to evaluate diagnosis accuracy on a statistical basis.
- Conditions
- All Surgical Conditions Usually Necessitating Frozen Section, Malignant Tumor, Inflammatory Disease, Benign Tumor
- Being tested
- pCLE, IV fluorescein administration
- Keywords
- pCLE, Digestive surgery, Endocrine surgery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCLEDevice
Histological examination by pCLE technique preceding the frozen section
IV fluorescein administrationDrug
IV Fluorescein (fluorescent contrast agent) administration
| Study group | Role | What they receive |
|---|---|---|
| pCLE | Experimental | Patients subject to endocrine or digestive surgery will have intraoperative pCLE examination. The installation and surgical opening will be performed according to standard protocols. The contrast agent, fluorescein, will be injected intravenously to allow tissue visualization with pCLE. During the surgery, the surgeon will perform the pCLE examination, to obtain and record video sequences of in situ structures. Frozen sections will be obtained on the same samples and will further guide the surgical decision-making. Receives: Device: pCLE; Drug: IV fluorescein administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis accuracy of intraoperative imaging with pCLE technique
The diagnosis proposed by the surgeon / investigator in intraoperative setting on the basis of video sequences of pCLE will be compared to frozen section.
Measured: During surgery
Secondary outcomes (4)
Diagnosis accuracy of pCLE imaging, retrospectively using the newly described diagnosis criteria
The diagnosis proposed by the surgeon / investigator after retrospective review of the intraoperative video sequences of pCLE based on the newly described diagnosis criteria will be compared to frozen section and conventional histology.
Measured: One year
pCLE video sequences interpretation learning curve
Comparison of the surgeon's ability to obtain intraoperative diagnosis relative to that of the pathologist in the same circumstances.
Measured: One year
Time needed for pCLE imaging procedure
Evaluation of the time required for the practice of pCLE and comparison to the time required for frozen section.
Measured: During surgery
Specific morbidity and mortality rate
Morbidity rate / mortality specific to the pCLE imaging procedure.
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start13 Oct 2015
- Primary completion14 Dec 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for All Surgical Conditions Usually Necessitating Frozen SectionStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihaela Ignat, MD, PhD, Principal investigator, Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil - Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552004
- Sponsor's protocol ID
- 15-001
- Acronym
- Pilot pCLE
- Status last verified
- Mar 2019
- First submitted
- 15 Sep 2015
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Wallace MB, Fockens P. Probe-based confocal laser endomicroscopy. Gastroenterology. 2009 May;136(5):1509-13. doi: 10.1053/j.gastro.2009.03.034. Epub 2009 Mar 28. No abstract available.
PubMed 19328799Ignat M, Aprahamian M, Lindner V, Altmeyer A, Perretta S, Dallemagne B, Mutter D, Marescaux J. Feasibility and reliability of pancreatic cancer staging using fiberoptic confocal fluorescence microscopy in rats. Gastroenterology. 2009 Nov;137(5):1584-92.e1. doi: 10.1053/j.gastro.2009.07.045. Epub 2009 Jul 24.
PubMed 19632230Kwan AS, Barry C, McAllister IL, Constable I. Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience. Clin Exp Ophthalmol. 2006 Jan-Feb;34(1):33-8. doi: 10.1111/j.1442-9071.2006.01136.x.
PubMed 16451256Ignat M, Lindner V, Vix M, Marescaux J, Mutter D. Intraoperative Probe-Based Confocal Endomicroscopy to Histologically Differentiate Thyroid From Parathyroid Tissue Before Resection. Surg Innov. 2019 Apr;26(2):141-148. doi: 10.1177/1553350618814078. Epub 2018 Nov 23.
PubMed 30466375
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery - a Pilot Study
- ClinicalTrials.gov ID
- NCT02552004
- Acronym / sponsor ID
- Pilot pCLE / 15-001
- Conditions
- All Surgical Conditions Usually Necessitating Frozen Section, Malignant Tumor, Inflammatory Disease, Benign Tumor
- Keywords
- pCLE, Digestive surgery, Endocrine surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 16 Sep 2015 (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.
Intraoperative histological examination is a fundamental tool in surgery. Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate pCLE in surgical setting. The objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the video sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images. The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.
Detailed description
Intraoperative histological examination is a fundamental tool for cancer surgery (extent of surgery, resection margins, sentinel lymph node) and necessary in other circumstances like redo surgery or endocrine surgery. Using conventional frozen section technique results in the prolongation of operating time of about 40 minutes.
Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging. Specifically, after intravenous injection of a fluorescent contrast agent - in this study fluorescein will be used, the pCLE system provides video sequences of the tissue, using a confocal microscope integrated in a miniprobe and a low power laser as the illumination source (Cellvizio®, Mauna Kea Technologies, Paris, France).
The pCLE is currently used in endoscopy, mainly for the follow-up of Barrett's esophagus, colorectal polyps and strictures of the bile and pancreatic ducts, but also in urology. The pCLE has never been tested in open or video-assisted surgery settings. Sterilizable probes exist and are certified for use via an endoscope in France (UHD CystoFlexTM, AQ-FLEX 19TM Mauna Kea Technologies, Paris, France). A probe (CelioFlex UHDTM) is currently being developed for use in laparoscopic surgery setting.
This pilot study aims to evaluate pCLE in surgical setting. Each anatomical structure corresponds to a specific tissue architecture, which is today known through standard histological examination. Conventional histology implies alteration of the tissue architecture, with ablation of blood supply, sampling and technical treatment of the samples (fixation, cutting, staining). The pCLE enables to bypass this process and allows obtaining images of the microscopic structure in vivo, without cell damage and without interruption of the blood and lymphatic circulation. The obtained video sequences reflect the microscopic architecture, in a form which is to date, neither mapped nor exploited for deep organs. The potential of this technique was demonstrated in intraabdominal organs only in the animal model, with very encouraging results as the sensitivity and specificity of pCLE were superior to standard histological examination.
The primary objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included.
The installation and surgical opening will be performed according to standard protocols. A contrast agent, fluorescein, will be injected intravenously to allow tissue visualization with the pCLE. During the surgery, the surgeon will perform the pCLE examination, to obtain and record video sequences of in situ structures. Frozen sections will be obtained on the same samples and will further guide the surgical decision-making.
Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images.
The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.
A second study, in comparative prospective settings, could further be focused only on the promising conditions in order to evaluate diagnosis accuracy on a statistical basis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pCLE | Experimental | Device: pCLE, Drug: IV fluorescein administrationPatients subject to endocrine or digestive surgery will have intraoperative pCLE examination. The installation and surgical opening will be performed according to standard protocols. The contrast agent, fluorescein, will be injected intravenously to allow tissue visualization with pCLE. During the surgery, the surgeon will perform the pCLE examination, to obtain and record video sequences of in situ structures. Frozen sections will be obtained on the same samples and will further guide the surgical decision-making. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient, male or female, over 18 years old
- Patient candidate to digestive or endocrine surgery in whom the surgeon deems necessary intraoperative frozen section
- Patient able to understand the study and to provide informed consent
- Patient affiliated to the French social security system
Key exclusion criteria (10 listed)
- Patient unable to provide informed consent
- Patient with known or suspected allergy to fluorescein
- Patient who had a previous life-threatening reaction during an angiography
- Patient with a history of multiple and severe allergic reactions to medications
- Patient taking a beta-blocker treatment
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 |
|---|---|---|
| pCLEHistological examination by pCLE technique preceding the frozen section | Device | pCLE |
| IV fluorescein administrationIV Fluorescein (fluorescent contrast agent) administration | Drug | pCLE |
Primary outcome
Diagnosis accuracy of intraoperative imaging with pCLE technique
Time frame: During surgery
The diagnosis proposed by the surgeon / investigator in intraoperative setting on the basis of video sequences of pCLE will be compared to frozen section.
4 secondary outcomes
Diagnosis accuracy of pCLE imaging, retrospectively using the newly described diagnosis criteria
Time frame: One year
pCLE video sequences interpretation learning curve
Time frame: One year
Time needed for pCLE imaging procedure
Time frame: During surgery
Specific morbidity and mortality rate
Time frame: One month after surgery
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 22 Mar 2019.
- Background: PubMed 19328799Wallace MB, Fockens P. Probe-based confocal laser endomicroscopy. Gastroenterology. 2009 May;136(5):1509-13. doi: 10.1053/j.gastro.2009.03.034. Epub 2009 Mar 28. No abstract available.
- Background: PubMed 19632230Ignat M, Aprahamian M, Lindner V, Altmeyer A, Perretta S, Dallemagne B, Mutter D, Marescaux J. Feasibility and reliability of pancreatic cancer staging using fiberoptic confocal fluorescence microscopy in rats. Gastroenterology. 2009 Nov;137(5):1584-92.e1. doi: 10.1053/j.gastro.2009.07.045. Epub 2009 Jul 24.
- Background: PubMed 16451256Kwan AS, Barry C, McAllister IL, Constable I. Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience. Clin Exp Ophthalmol. 2006 Jan-Feb;34(1):33-8. doi: 10.1111/j.1442-9071.2006.01136.x.
- Results publication: PubMed 30466375Ignat M, Lindner V, Vix M, Marescaux J, Mutter D. Intraoperative Probe-Based Confocal Endomicroscopy to Histologically Differentiate Thyroid From Parathyroid Tissue Before Resection. Surg Innov. 2019 Apr;26(2):141-148. doi: 10.1177/1553350618814078. Epub 2018 Nov 23.
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.
Mihaela Ignat, MD, PhD principal investigator
Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil - Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pCLE and IV fluorescein administration in people with All Surgical Conditions Usually Necessitating Frozen Section and Malignant Tumor, run by IHU Strasbourg at 1 site 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 4 inclusion and 10 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Diagnosis accuracy of intraoperative imaging with pCLE technique (time frame: During surgery). 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 NCT02552004, which also lists 4 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 22 Mar 2019.