pCLE in the Detection of Esophageal and Gastric Lesions and Intestinal Metaplasia or Dysplasia in Patients After Endoscopic Treatment of BORN

Barrett's Esophagus Clinical Trial

Official title:

Probe-based Confocal Laser Endomicroscopy in Accurate Histopathologic Diagnosis of Neoplastic Gastrointestinal Lesion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922049
• Other study ID #: 16-27648A
• Secondary ID: G280
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 2020

Study information

• Verified date: February 2020
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• macroscopic persistence of Barrett's esophagus (e.g. tongues)

• esophageal varices

• treatment with anticoagulants

• allergy to fluorescein

• polyvalent allergy

• pregnancy

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Metaplasia

Intervention

Other:
• Biopsies with histopathology
All samples taken by biopsies will be correlated with the images taken by CLE.

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague 4	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

References & Publications (11)

Konda 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. — View Citation

Kopácová M, Bures J, Osterreicher J, Kvetina J, Pejchal J, Tachecí 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. — View Citation

Mannath 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. — View Citation

Meining 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. — View Citation

Musquer 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. — View Citation

Napoléon 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. — View Citation

Shahid 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. — View Citation

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. — View Citation

Siddiqui 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. — View Citation

Wallace 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. — View Citation

Wang 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. Review. Erratum in: United European Gastroenterol J. 2015 Aug;3(4):404. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of persistent or recurrent intestinal metaplasia/dysplasia and esophageal and gastric lesions by confocal laser endomicroscopy and classic histopathology		till 3 day after procedure
Secondary	Sensitivity and specificity of the procedure		through study completion, an average of 1 year