Barrett's EsophagusNCT02922049
pCLE in the Detection of Esophageal and Gastric Lesions and Intestinal Metaplasia or Dysplasia in Patients After Endoscopic Treatment of BORN
A study testing Biopsies with histopathology in people with Barrett's Esophagus, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting persistent/recurrent IM, recurrent neoplasia and buried glands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Biopsies with histopathology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2016to Jan 2020
- 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
- age > 18
- macroscopic lesion of esophagus or stomach (Project A)
- pts after ER/ESD/RFA for BORN (Project B)
- eradication of BORN and Barrett's esophagus macro- and microscopically (Project B)
- sign agreement with study
Who cannot join
- macroscopic persistence of Barrett's esophagus (e.g. tongues)
- esophageal varices
- treatment with anticoagulants
- allergy to fluorescein
- polyvalent allergy
- pregnancy
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Institute for Clinical and Experimental Medicine
Prague, Prague, 14021
About this study
Official title: Probe-based Confocal Laser Endomicroscopy in Accurate Histopathologic Diagnosis of Neoplastic Gastrointestinal Lesion
To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting persistent/recurrent IM, recurrent neoplasia and buried glands.
Read the detailed description
Confocal laser endomicroscopy (CLE) has been developed to overcome the limitations of the current endoscopic sampling techniques. CLE allows detailed examination of cellular structures since it provides images very similar to images which a pathologist can see in the microscope. At present, probe based CLE (pCLE) is the only available technology of endomicroscopy. Before optical biopsy, a fluorescein is given intravenously and then fluorescent light coming from a horizontal special focal plane is detected during pCLE of the digestive system.
CLE provide real-time histopathological diagnosis and can lead to an immediate endoscopic treatment in case of early esophageal and gastric neoplasia.
Patients after treatment of Barrett's esophagus related esophageal neoplasia (dysplasia or early cancer) should be surveilled endoscopically with biopsies to rule out relapse of Barrett's esophagus or neoplasia.
Project A - pCLE in the detection of esophageal and gastric lesions:
We plan to investigate the diagnostic accuracy of pCLE (compared to standard histopathology) in patients with endoscopically diagnosed early esophageal and gastric lesions.
Project B - pCLE in the detection of persistent/recurrent intestinal metaplasia/dysplasia in patients after endoscopic treatment of BORN:
Investigators plan to perform a prospective cross-over study comparing the diagnostic accuracy and sensitivity of pCLE with standard biopsies in patients after completed endoscopic treatment of BORN. Surveillance endoscopies are focused on detection of persistent/recurrent IM or dysplasia (ev. neoplasia). BORN is defined as low-grade dysplasia (confirmed by a specialized esophageal pathologist) or as high grade dysplasia or early adenocarcinoma. Investigators will also examine the ability of pCLE to detect buried glands after radiofrequency ablation.
Methods:
Project A:
Patients referred to our department with a suspect and endoscopically visible lesion in the esophagus or stomach will undergo pCLE during a standard upper GI endoscopy with pCLE. After a real-time diagnosis (made by the endoscopist), the standard tissue sampling (biopsies, endoscopic resection or dissection) followed by a standard histopathological tissue assessment will follow.
Project B:
During one of surveillance endoscopies in patients after finishing the endoscopic treatment of BORN (interval depends on baseline diagnosis), pCLE will be performed in the cardia, neo-Z-line, esophagus body and visible lesions, and images will be stored. Thereafter, standard biopsies will be taken and sent for histopathological analysis.
For optical biopsy, endoscopist (real time) and two expert pathologists will independently blindly evaluate each "optical specimen". The standard biopsy specimen will be assessed independently by a pathologist not assessing the optical biopsy. Results of optical biopsy will be compared with results of standard biopsy.
Main hypothesis:
Project A:
pCLE is not inferior to standard biopsy (or resection) specimen in histopathological diagnosing of esophageal/gastric lesions.
Project B:
pCLE is not inferior compared to standard biopsies in detecting persistent/recurrent IM, recurrent neoplasia and buried glands.
- Conditions
- Barrett's Esophagus
- Being tested
- Biopsies with histopathology
- Keywords
- Probe Based Confocal Laser Endomicroscopy (pCLE), Barrett's esophagus, BORN, Intestinal metaplasia
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies with histopathologyOther
All samples taken by biopsies will be correlated with the images taken by CLE.
| Study group | Role | What they receive |
|---|---|---|
| pCLE vs. biopsies with histopathology | Other | The investigators will compare diagnostic accuracy and sensitivity of pCLE with standard biopsies in patients with esophageal and gastric lesions and in patients after completed endoscopic treatment of BORN.
All samples taken by biopsies will be correlated with the images taken by pCLE in the detection of lesions, intestinal metaplasia, dysplasia and buried glands. Receives: Other: Biopsies with histopathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of persistent or recurrent intestinal metaplasia/dysplasia and esophageal and gastric lesions by confocal laser endomicroscopy and classic histopathology
Measured: till 3 day after procedure
Secondary outcomes (1)
Sensitivity and specificity of the procedure
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Institute for Clinical and Experimental Medicine
- Investigators
- Jan Martinek, MD. PhD., Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922049
- Sponsor's protocol ID
- 16-27648A
- Other IDs
- G280
- Status last verified
- Feb 2020
- First submitted
- 23 Sep 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13.
PubMed 21741642Meining A, Shah RJ, Slivka A, Pleskow D, Chuttani R, Stevens PD, Becker V, Chen YK. Classification of probe-based confocal laser endomicroscopy findings in pancreaticobiliary strictures. Endoscopy. 2012 Mar;44(3):251-7. doi: 10.1055/s-0031-1291545. Epub 2012 Jan 19.
PubMed 22261749Shahid MW, Buchner AM, Coron E, Woodward TA, Raimondo M, Dekker E, Fockens P, Wallace MB. Diagnostic accuracy of probe-based confocal laser endomicroscopy in detecting residual colorectal neoplasia after EMR: a prospective study. Gastrointest Endosc. 2012 Mar;75(3):525-33. doi: 10.1016/j.gie.2011.08.024. Epub 2011 Nov 1.
PubMed 22051243Musquer N, Coquenlorge S, Bourreille A, Aubert P, Matysiak-Budnik T, des Varannes SB, Lauwers G, Neunlist M, Coron E. Probe-based confocal laser endomicroscopy: a new method for quantitative analysis of pit structure in healthy and Crohn's disease patients. Dig Liver Dis. 2013 Jun;45(6):487-92. doi: 10.1016/j.dld.2013.01.018. Epub 2013 Mar 7.
PubMed 23466186Mannath J, Subramanian V, Kaye PV, Ragunath K. Life-threatening bleeding following Barrett's surveillance biopsies. Endoscopy. 2010;42 Suppl 2:E211-2. doi: 10.1055/s-0030-1255717. Epub 2010 Sep 15. No abstract available.
PubMed 20845277Kopacova M, Bures J, Osterreicher J, Kvetina J, Pejchal J, Tacheci I, Kunes M, Spelda S, Rejchrt S. Confocal laser endomicroscopy in experimental pigs. Methods of ex vivo imaging. Cas Lek Cesk. 2009;148(6):249-53.
PubMed 19642306Wang KK, Carr-Locke DL, Singh SK, Neumann H, Bertani H, Galmiche JP, Arsenescu RI, Caillol F, Chang KJ, Chaussade S, Coron E, Costamagna G, Dlugosz A, Ian Gan S, Giovannini M, Gress FG, Haluszka O, Ho KY, Kahaleh M, Konda VJ, Prat F, Shah RJ, Sharma P, Slivka A, Wolfsen HC, Zfass A. Use of probe-based confocal laser endomicroscopy (pCLE) in gastrointestinal applications. A consensus report based on clinical evidence. United European Gastroenterol J. 2015 Jun;3(3):230-54. doi: 10.1177/2050640614566066.
PubMed 26137298Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.
PubMed 22749368Konda VJ, Meining A, Jamil LH, Giovannini M, Hwang JH, Wallace MB, Chang KJ, Siddiqui UD, Hart J, Lo SK, Saunders MD, Aslanian HR, Wroblewski K, Waxman I. A pilot study of in vivo identification of pancreatic cystic neoplasms with needle-based confocal laser endomicroscopy under endosonographic guidance. Endoscopy. 2013 Dec;45(12):1006-13. doi: 10.1055/s-0033-1344714. Epub 2013 Oct 25.
PubMed 24163192Siddiqui AA, Shahid H, Shah A, Khurana T, Huntington W, Ghumman SS, Loren DE, Kowalski TE, Laique S, Hayat U, Eloubeidi MA. High risk of acute pancreatitis after endoscopic ultrasound-guided fine needle aspiration of side branch intraductal papillary mucinous neoplasms. Endosc Ultrasound. 2015 Apr-Jun;4(2):109-14. doi: 10.4103/2303-9027.156728.
PubMed 26020044Napoleon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme D, Bourdariat R, Morellon-Mialhe B, Fumex F, Lefort C, Lepilliez V, Palazzo L, Monges G, Filoche B, Giovannini M. A novel approach to the diagnosis of pancreatic serous cystadenoma: needle-based confocal laser endomicroscopy. Endoscopy. 2015 Jan;47(1):26-32. doi: 10.1055/s-0034-1390693. Epub 2014 Oct 17.
PubMed 25325684Kollar M, Krajciova J, Prefertusova L, Sticova E, Maluskova J, Vackova Z, Martinek J. Probe-based confocal laser endomicroscopy versus biopsies in the diagnostics of oesophageal and gastric lesions: A prospective, pathologist-blinded study. United European Gastroenterol J. 2020 May;8(4):436-443. doi: 10.1177/2050640620904865. Epub 2020 Jan 28.
PubMed 32213027
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe-based Confocal Laser Endomicroscopy in Accurate Histopathologic Diagnosis of Neoplastic Gastrointestinal Lesion
- ClinicalTrials.gov ID
- NCT02922049
- Acronym / sponsor ID
- 16-27648A
- Conditions
- Barrett's Esophagus
- Keywords
- Probe Based Confocal Laser Endomicroscopy (pCLE), Barrett's esophagus, BORN, Intestinal metaplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 3 Oct 2016 (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.
To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting persistent/recurrent IM, recurrent neoplasia and buried glands.
Detailed description
Confocal laser endomicroscopy (CLE) has been developed to overcome the limitations of the current endoscopic sampling techniques. CLE allows detailed examination of cellular structures since it provides images very similar to images which a pathologist can see in the microscope. At present, probe based CLE (pCLE) is the only available technology of endomicroscopy. Before optical biopsy, a fluorescein is given intravenously and then fluorescent light coming from a horizontal special focal plane is detected during pCLE of the digestive system.
CLE provide real-time histopathological diagnosis and can lead to an immediate endoscopic treatment in case of early esophageal and gastric neoplasia.
Patients after treatment of Barrett's esophagus related esophageal neoplasia (dysplasia or early cancer) should be surveilled endoscopically with biopsies to rule out relapse of Barrett's esophagus or neoplasia.
Project A - pCLE in the detection of esophageal and gastric lesions:
We plan to investigate the diagnostic accuracy of pCLE (compared to standard histopathology) in patients with endoscopically diagnosed early esophageal and gastric lesions.
Project B - pCLE in the detection of persistent/recurrent intestinal metaplasia/dysplasia in patients after endoscopic treatment of BORN:
Investigators plan to perform a prospective cross-over study comparing the diagnostic accuracy and sensitivity of pCLE with standard biopsies in patients after completed endoscopic treatment of BORN. Surveillance endoscopies are focused on detection of persistent/recurrent IM or dysplasia (ev. neoplasia). BORN is defined as low-grade dysplasia (confirmed by a specialized esophageal pathologist) or as high grade dysplasia or early adenocarcinoma. Investigators will also examine the ability of pCLE to detect buried glands after radiofrequency ablation.
Methods:
Project A:
Patients referred to our department with a suspect and endoscopically visible lesion in the esophagus or stomach will undergo pCLE during a standard upper GI endoscopy with pCLE. After a real-time diagnosis (made by the endoscopist), the standard tissue sampling (biopsies, endoscopic resection or dissection) followed by a standard histopathological tissue assessment will follow.
Project B:
During one of surveillance endoscopies in patients after finishing the endoscopic treatment of BORN (interval depends on baseline diagnosis), pCLE will be performed in the cardia, neo-Z-line, esophagus body and visible lesions, and images will be stored. Thereafter, standard biopsies will be taken and sent for histopathological analysis.
For optical biopsy, endoscopist (real time) and two expert pathologists will independently blindly evaluate each "optical specimen". The standard biopsy specimen will be assessed independently by a pathologist not assessing the optical biopsy. Results of optical biopsy will be compared with results of standard biopsy.
Main hypothesis:
Project A:
pCLE is not inferior to standard biopsy (or resection) specimen in histopathological diagnosing of esophageal/gastric lesions.
Project B:
pCLE is not inferior compared to standard biopsies in detecting persistent/recurrent IM, recurrent neoplasia and buried glands.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pCLE vs. biopsies with histopathology | Other | Other: Biopsies with histopathologyThe investigators will compare diagnostic accuracy and sensitivity of pCLE with standard biopsies in patients with esophageal and gastric lesions and in patients after completed endoscopic treatment of BORN. All samples taken by biopsies will be correlated with the images taken by pCLE in the detection of lesions, intestinal metaplasia, dysplasia and buried glands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18
- macroscopic lesion of esophagus or stomach (Project A)
- pts after ER/ESD/RFA for BORN (Project B)
- eradication of BORN and Barrett's esophagus macro- and microscopically (Project B)
- sign agreement with study
Key exclusion criteria (6 listed)
- macroscopic persistence of Barrett's esophagus (e.g. tongues)
- esophageal varices
- treatment with anticoagulants
- allergy to fluorescein
- polyvalent allergy
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 |
|---|---|---|
| Biopsies with histopathologyAll samples taken by biopsies will be correlated with the images taken by CLE. | Other | pCLE vs. biopsies with histopathology |
Primary outcome
Detection of persistent or recurrent intestinal metaplasia/dysplasia and esophageal and gastric lesions by confocal laser endomicroscopy and classic histopathology
Time frame: till 3 day after procedure
1 secondary outcome
Sensitivity and specificity of the procedure
Time frame: through study completion, an average of 1 year
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 18 Feb 2020.
- Background: PubMed 21741642Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13.
- Background: PubMed 22261749Meining A, Shah RJ, Slivka A, Pleskow D, Chuttani R, Stevens PD, Becker V, Chen YK. Classification of probe-based confocal laser endomicroscopy findings in pancreaticobiliary strictures. Endoscopy. 2012 Mar;44(3):251-7. doi: 10.1055/s-0031-1291545. Epub 2012 Jan 19.
- Background: PubMed 22051243Shahid MW, Buchner AM, Coron E, Woodward TA, Raimondo M, Dekker E, Fockens P, Wallace MB. Diagnostic accuracy of probe-based confocal laser endomicroscopy in detecting residual colorectal neoplasia after EMR: a prospective study. Gastrointest Endosc. 2012 Mar;75(3):525-33. doi: 10.1016/j.gie.2011.08.024. Epub 2011 Nov 1.
- Background: PubMed 23466186Musquer N, Coquenlorge S, Bourreille A, Aubert P, Matysiak-Budnik T, des Varannes SB, Lauwers G, Neunlist M, Coron E. Probe-based confocal laser endomicroscopy: a new method for quantitative analysis of pit structure in healthy and Crohn's disease patients. Dig Liver Dis. 2013 Jun;45(6):487-92. doi: 10.1016/j.dld.2013.01.018. Epub 2013 Mar 7.
- Background: PubMed 20845277Mannath J, Subramanian V, Kaye PV, Ragunath K. Life-threatening bleeding following Barrett's surveillance biopsies. Endoscopy. 2010;42 Suppl 2:E211-2. doi: 10.1055/s-0030-1255717. Epub 2010 Sep 15. No abstract available.
- Background: PubMed 19642306Kopacova M, Bures J, Osterreicher J, Kvetina J, Pejchal J, Tacheci I, Kunes M, Spelda S, Rejchrt S. Confocal laser endomicroscopy in experimental pigs. Methods of ex vivo imaging. Cas Lek Cesk. 2009;148(6):249-53.
- Background: PubMed 26137298Wang KK, Carr-Locke DL, Singh SK, Neumann H, Bertani H, Galmiche JP, Arsenescu RI, Caillol F, Chang KJ, Chaussade S, Coron E, Costamagna G, Dlugosz A, Ian Gan S, Giovannini M, Gress FG, Haluszka O, Ho KY, Kahaleh M, Konda VJ, Prat F, Shah RJ, Sharma P, Slivka A, Wolfsen HC, Zfass A. Use of probe-based confocal laser endomicroscopy (pCLE) in gastrointestinal applications. A consensus report based on clinical evidence. United European Gastroenterol J. 2015 Jun;3(3):230-54. doi: 10.1177/2050640614566066.
- Background: PubMed 22749368Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.
- Background: PubMed 24163192Konda VJ, Meining A, Jamil LH, Giovannini M, Hwang JH, Wallace MB, Chang KJ, Siddiqui UD, Hart J, Lo SK, Saunders MD, Aslanian HR, Wroblewski K, Waxman I. A pilot study of in vivo identification of pancreatic cystic neoplasms with needle-based confocal laser endomicroscopy under endosonographic guidance. Endoscopy. 2013 Dec;45(12):1006-13. doi: 10.1055/s-0033-1344714. Epub 2013 Oct 25.
- Background: PubMed 26020044Siddiqui AA, Shahid H, Shah A, Khurana T, Huntington W, Ghumman SS, Loren DE, Kowalski TE, Laique S, Hayat U, Eloubeidi MA. High risk of acute pancreatitis after endoscopic ultrasound-guided fine needle aspiration of side branch intraductal papillary mucinous neoplasms. Endosc Ultrasound. 2015 Apr-Jun;4(2):109-14. doi: 10.4103/2303-9027.156728.
- Background: PubMed 25325684Napoleon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme D, Bourdariat R, Morellon-Mialhe B, Fumex F, Lefort C, Lepilliez V, Palazzo L, Monges G, Filoche B, Giovannini M. A novel approach to the diagnosis of pancreatic serous cystadenoma: needle-based confocal laser endomicroscopy. Endoscopy. 2015 Jan;47(1):26-32. doi: 10.1055/s-0034-1390693. Epub 2014 Oct 17.
- Derived from this study: PubMed 32213027Kollar M, Krajciova J, Prefertusova L, Sticova E, Maluskova J, Vackova Z, Martinek J. Probe-based confocal laser endomicroscopy versus biopsies in the diagnostics of oesophageal and gastric lesions: A prospective, pathologist-blinded study. United European Gastroenterol J. 2020 May;8(4):436-443. doi: 10.1177/2050640620904865. Epub 2020 Jan 28.
- Individual participant dataSharing planned: Yes
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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.
Jan Martinek, MD. PhD. principal investigator
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies with histopathology in people with Barrett's Esophagus, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 5 inclusion and 6 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 18 Feb 2020. 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 Czechia. 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?
Detection of persistent or recurrent intestinal metaplasia/dysplasia and esophageal and gastric lesions by confocal laser endomicroscopy and classic histopathology (time frame: till 3 day after procedure). 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 NCT02922049, which also lists 12 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 18 Feb 2020.