Cystic Pancreatic DisordersINDEXNCT02516488
Comparison of CLE in Vivo Diagnosis and ex Vivo Examination Against Surgical Histopathology of CPL
An observational study of Cystic Pancreatic Disorders, run by Somashekar Krishna at 1 site in United States.
Trial summary
Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Pancreatic Disorders
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Mar 2019
- Phase
- Observational
- 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
Study population: Patients with Cystic Pancreatic Lesions
Who may be able to join
- For in vivo nCLE (needle-based confocal laser endomicroscopy) (Part 1):
- Patient age 18 years and older
- All patients referred for EUS-FNA (endoscopic ultrasound - fine needle aspiration) of accessible CPL (cystic pancreatic lesion)
- The minimum size of the cyst should be ≥ 1.5 cm as determined by prior cross-sectional imaging studies.
- For ex vivo pCLE (probe-based confocal laser endomicroscopy) (Part 2):
- All patients must satisfy inclusive criteria for in vivo nCLE.
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- All patients should have completed EUS-guided nCLE.
- All patients should have a CPL lesion referred for surgical removal based on recommended international consensus guidelines1 and inter-departmental consensus pancreatic tumor board meeting (departments of surgical oncology, radiology, pathology and gastroenterology).
- Patient participated and completed in vivo nCLE (Part 1)
Who cannot join
- Unable to obtain informed consent
- Unable to tolerate the procedure
- Women with known pregnancy at time of procedure
- Patient age less than 18 years
- Bleeding diathesis
- Lesion not accessible by EUS guided FNA
- Allergy to fluorescein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Confocal Laser Endomicroscopic IN Vivo Diagnosis and EX Vivo Examination (INDEX Study) Against Surgical Histopathology of Cystic Pancreatic Lesions
Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.
Read the detailed description
The primary objective of the study is to assess the ability of nCLE (AQ-Flex) to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs. The primary endpoints are whether or not the CLE diagnosis correlates with final diagnosis (yes vs. no).
- Conditions
- Cystic Pancreatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy)
Comparing the ability of nCLE to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs.
Measured: 12 months
Secondary outcomes (2)
Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging
Measured: 12 months
CLE imaging interpretation variation
Calculate inter-observer variation in CLE image interpretation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2019
- Study completionMar 2019
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 Cystic Pancreatic DisordersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somashekar Krishna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Somashekar Krishna, Ohio State University
- Investigators
- Somashekar Krishna, MD, MPH, Principal investigator, Ohio State Wexner Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516488
- Sponsor's protocol ID
- 2014C0205
- Acronym
- INDEX
- Status last verified
- Oct 2019
- First submitted
- 30 Jul 2015
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Krishna SG, Hart PA, DeWitt JM, DiMaio CJ, Kongkam P, Napoleon B, Othman MO, Yew Tan DM, Strobel SG, Stanich PP, Patel A, Luthra AK, Chan MQ, Blaszczak AM, Lee D, El-Dika S, McCarthy ST, Walker JP, Arnold CA, Porter K, Conwell DL. EUS-guided confocal laser endomicroscopy: prediction of dysplasia in intraductal papillary mucinous neoplasms (with video). Gastrointest Endosc. 2020 Mar;91(3):551-563.e5. doi: 10.1016/j.gie.2019.09.014. Epub 2019 Sep 19.
PubMed 31542380Krishna SG, Hart PA, Malli A, Kruger AJ, McCarthy ST, El-Dika S, Walker JP, Dillhoff ME, Manilchuk A, Schmidt CR, Pawlik TM, Porter K, Arnold CA, Cruz-Monserrate Z, Conwell DL. Endoscopic Ultrasound-Guided Confocal Laser Endomicroscopy Increases Accuracy of Differentiation of Pancreatic Cystic Lesions. Clin Gastroenterol Hepatol. 2020 Feb;18(2):432-440.e6. doi: 10.1016/j.cgh.2019.06.010. Epub 2019 Jun 18.
PubMed 31220640Krishna SG, Brugge WR, Dewitt JM, Kongkam P, Napoleon B, Robles-Medranda C, Tan D, El-Dika S, McCarthy S, Walker J, Dillhoff ME, Manilchuk A, Schmidt C, Swanson B, Shah ZK, Hart PA, Conwell DL. Needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cystic lesions: an international external interobserver and intraobserver study (with videos). Gastrointest Endosc. 2017 Oct;86(4):644-654.e2. doi: 10.1016/j.gie.2017.03.002. Epub 2017 Mar 10.
PubMed 28286093Krishna SG, Swanson B, Hart PA, El-Dika S, Walker JP, McCarthy ST, Malli A, Shah ZK, Conwell DL. Validation of diagnostic characteristics of needle based confocal laser endomicroscopy in differentiation of pancreatic cystic lesions. Endosc Int Open. 2016 Nov;4(11):E1124-E1135. doi: 10.1055/s-0042-116491. Epub 2016 Sep 30.
PubMed 27853737
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Confocal Laser Endomicroscopic IN Vivo Diagnosis and EX Vivo Examination (INDEX Study) Against Surgical Histopathology of Cystic Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT02516488
- Acronym / sponsor ID
- INDEX / 2014C0205
- Conditions
- Cystic Pancreatic Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Somashekar KrishnaUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 6 Aug 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.
Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.
Detailed description
The primary objective of the study is to assess the ability of nCLE (AQ-Flex) to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs. The primary endpoints are whether or not the CLE diagnosis correlates with final diagnosis (yes vs. no).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Cystic Pancreatic Lesions
Key inclusion criteria (9 listed)
- Patient age 18 years and older
- All patients referred for EUS-FNA (endoscopic ultrasound - fine needle aspiration) of accessible CPL (cystic pancreatic lesion)
- The minimum size of the cyst should be ≥ 1.5 cm as determined by prior cross-sectional imaging studies.
- All patients must satisfy inclusive criteria for in vivo nCLE.
- All patients should have completed EUS-guided nCLE.
Key exclusion criteria (7 listed)
- Unable to obtain informed consent
- Unable to tolerate the procedure
- Women with known pregnancy at time of procedure
- Patient age less than 18 years
- Bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy)
Time frame: 12 months
Comparing the ability of nCLE to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs.
2 secondary outcomes
Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging
Time frame: 12 months
CLE imaging interpretation variation
Time frame: 12 months
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 17 Oct 2019.
- Derived from this study: PubMed 31542380Krishna SG, Hart PA, DeWitt JM, DiMaio CJ, Kongkam P, Napoleon B, Othman MO, Yew Tan DM, Strobel SG, Stanich PP, Patel A, Luthra AK, Chan MQ, Blaszczak AM, Lee D, El-Dika S, McCarthy ST, Walker JP, Arnold CA, Porter K, Conwell DL. EUS-guided confocal laser endomicroscopy: prediction of dysplasia in intraductal papillary mucinous neoplasms (with video). Gastrointest Endosc. 2020 Mar;91(3):551-563.e5. doi: 10.1016/j.gie.2019.09.014. Epub 2019 Sep 19.
- Derived from this study: PubMed 31220640Krishna SG, Hart PA, Malli A, Kruger AJ, McCarthy ST, El-Dika S, Walker JP, Dillhoff ME, Manilchuk A, Schmidt CR, Pawlik TM, Porter K, Arnold CA, Cruz-Monserrate Z, Conwell DL. Endoscopic Ultrasound-Guided Confocal Laser Endomicroscopy Increases Accuracy of Differentiation of Pancreatic Cystic Lesions. Clin Gastroenterol Hepatol. 2020 Feb;18(2):432-440.e6. doi: 10.1016/j.cgh.2019.06.010. Epub 2019 Jun 18.
- Derived from this study: PubMed 28286093Krishna SG, Brugge WR, Dewitt JM, Kongkam P, Napoleon B, Robles-Medranda C, Tan D, El-Dika S, McCarthy S, Walker J, Dillhoff ME, Manilchuk A, Schmidt C, Swanson B, Shah ZK, Hart PA, Conwell DL. Needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cystic lesions: an international external interobserver and intraobserver study (with videos). Gastrointest Endosc. 2017 Oct;86(4):644-654.e2. doi: 10.1016/j.gie.2017.03.002. Epub 2017 Mar 10.
- Derived from this study: PubMed 27853737Krishna SG, Swanson B, Hart PA, El-Dika S, Walker JP, McCarthy ST, Malli A, Shah ZK, Conwell DL. Validation of diagnostic characteristics of needle based confocal laser endomicroscopy in differentiation of pancreatic cystic lesions. Endosc Int Open. 2016 Nov;4(11):E1124-E1135. doi: 10.1055/s-0042-116491. Epub 2016 Sep 30.
- Individual participant dataSharing planned: No
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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.
Somashekar Krishna, MD, MPH principal investigator
Ohio State Wexner Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Pancreatic Disorders, run by Somashekar Krishna at 1 site in United States.
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 9 inclusion and 7 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 17 Oct 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 United States. 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 of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy) (time frame: 12 months). 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 NCT02516488, 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 17 Oct 2019.