Endomicroscopy and Gastric MALT-lymphoma

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue (MALT-lymphoma) represents a distinct clinical entity and is the most common form of extranodal lymphoma, with a predilection for the stomach. About 90% of gastric MALT-lymphomas are associated with infection with Helicobacter pylori (HP) and eradication of the pathogen leads to regression of the tumor in a high percentage of patients at early tumour stages. Nevertheless, following complete remission after HP-eradication, the risk of relapse justifies lifelong follow-up examinations. Supported by recent findings at the investigators department, endoscopic controls should include a close examination of the small bowel, as relapses can involve different gastrointestinal sites. To continue the investigators diagnostic approach as well as to further improve the detection rate of MALT-lymphoma relapses, the investigators plan to introduce the novel confocal laser endomicroscope (CLE) into the diagnostic management of MALT-lymphoma patients. In the context of a prospective clinical pilot trial the investigators aim to establish MALT-lymphoma specific CLE-markers that can be used for the in vivo diagnosis of the disease. Comparing endomicroscopic findings, drawn from the stomach and small bowel of 50 MALT-lymphoma patients who will undergo staging or follow up endoscopies at the investigators department, to the histological evaluation of biopsy samples as present gold standard, the investigators want to determine whether CLE can provide reliable data for the accurate detection of MALT-lymphoma associated changes. Endomicroscopic aspects of patients with chronic gastritis, gastric adenocarcinoma and healthy subjects should serve as controls. In comparison to random biopsies which represent the current standard, the investigators aim to prove, whether endomicroscopy will find MALT-lymphoma lesions more accurately and thus help to spare patients unnecessary biopsies.

Condition or disease	Intervention/treatment	Phase
MALT-lymphoma	Procedure: Confocal laser endomicroscopy; Device: Confocal Laser Endomicroscope	Not Applicable

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Confocal Laser Endomicroscopy as Diagnostic Tool for Gastrointestinal MALT-lymphoma
Study Start Date :	April 2012
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	March 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Endomicroscopy; All patients included into the study will undergo endomicroscopy of the upper GI-tract.	Procedure: Confocal laser endomicroscopy; Endomicroscopy of the upper gastrointestinal tract to capture endomicroscopic pictures from the small bowel, stomach and esophagus. Device: Confocal Laser Endomicroscope; Pentax EC-3870 CIFK with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Qualitative MALT-features on Endomicroscopy [ Time Frame: 2 years ]
   Establishing endomicroscopic features of MALT-lymphoma in the upper gastrointestinal tract. This outcome is a qualitative endpoint that will be assessed only descriptively.

Secondary Outcome Measures :

1. Sensitivity and Specificity of Endomicroscopy to diagnose GI-MALT-Lymphoma [ Time Frame: 2 years ]
   At the end of the study, endomicroscopic pictures gained during the study will be assessed by two blinded pathologists regarding judgement on MALT-lymphoma presence or absence. The results will be compared to the corresponding histological sections in order to calculate sensitivity ans specificity for the technique.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients referred to our department for upper endoscopy in the context of staging or follow-up of gastric MALT-lymphoma.

Exclusion criteria:

• patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE )
• refusal to participate in the study
• patient's age below 18 years

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Austria
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Vienna, Austria

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:	Werner Dolak, MD	Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie
Study Director:	Andreas Puespoek, m	Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Study Chair:	Markus Raderer, MD	Medical University of Vienna, Department of Internal Medicine I, Division of Oncology

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Ott G, Balague-Ponz O, de Leval L, de Jong D, Hasserjian RP, Elenitoba-Johnson KS. Commentary on the WHO classification of tumors of lymphoid tissues (2008): indolent B cell lymphomas. J Hematop. 2009 Jul;2(2):77-81. doi: 10.1007/s12308-009-0037-9. Epub 2009 Jun 25.

Ferreri AJ, Zucca E. Marginal-zone lymphoma. Crit Rev Oncol Hematol. 2007 Sep;63(3):245-56. Epub 2007 Jun 20. Review.

Morgner A, Schmelz R, Thiede C, Stolte M, Miehlke S. Therapy of gastric mucosa associated lymphoid tissue lymphoma. World J Gastroenterol. 2007 Jul 14;13(26):3554-66. Review.

Zullo A, Hassan C, Andriani A, Cristofari F, De Francesco V, Ierardi E, Tomao S, Morini S, Vaira D. Eradication therapy for Helicobacter pylori in patients with gastric MALT lymphoma: a pooled data analysis. Am J Gastroenterol. 2009 Aug;104(8):1932-7; quiz 1938. doi: 10.1038/ajg.2009.314. Epub 2009 Jun 16. Review.

Terai S, Iijima K, Kato K, Dairaku N, Suzuki T, Yoshida M, Koike T, Kitagawa Y, Imatani A, Sekine H, Ohara S, Shimosegawa T. Long-term outcomes of gastric mucosa-associated lymphoid tissue lymphomas after Helicobacter pylori eradication therapy. Tohoku J Exp Med. 2008 Jan;214(1):79-87.

Raderer M, Isaacson PG. Extranodal lymphoma of MALT-type: perspective at the beginning of the 21st century. Expert Rev Anticancer Ther. 2001 Jun;1(1):53-64. Review.

Raderer M, Streubel B, Woehrer S, Puespoek A, Jaeger U, Formanek M, Chott A. High relapse rate in patients with MALT lymphoma warrants lifelong follow-up. Clin Cancer Res. 2005 May 1;11(9):3349-52.

Isaacson PG. Gastric MALT lymphoma: from concept to cure. Ann Oncol. 1999 Jun;10(6):637-45. Review.

Dolak W, Raderer M, Maresch J, Muellauer L, Puespoek A, Chott A, Haefner M. Detection of gastric MALT lymphoma spreading to the small bowel by enteroscopy. Endoscopy. 2011 Aug;43(8):731-3. doi: 10.1055/s-0030-1256435. Epub 2011 Jun 7.

Hyatt BJ, Paull PE, Wassef W. Gastric oncology: an update. Curr Opin Gastroenterol. 2009 Nov;25(6):570-8. doi: 10.1097/MOG.0b013e328331b5c9. Review.

Püspök A, Raderer M, Chott A, Dragosics B, Gangl A, Schöfl R. Endoscopic ultrasound in the follow up and response assessment of patients with primary gastric lymphoma. Gut. 2002 Nov;51(5):691-4.

Al-Taie OH, Dietrich CF, Dietrich CG, Fischbach W. [Role of endoscopic ultrasound in gastrointestinal lymphomas]. Z Gastroenterol. 2008 Jun;46(6):618-24. doi: 10.1055/s-2008-1027517. Review. German.

Kiesslich R, Galle P, Neurath M. Atlas of endomicroscopy. Springer Medical Publishing. 2008

Kiesslich R, Goetz M, Burg J, Stolte M, Siegel E, Maeurer MJ, Thomas S, Strand D, Galle PR, Neurath MF. Diagnosing Helicobacter pylori in vivo by confocal laser endoscopy. Gastroenterology. 2005 Jun;128(7):2119-23.

Dolak W, Leitner J, Maresch J, Wrba F, Mueller C. In vivo identification by confocal laser endoscopy of foamy macrophages associated with Whipple's disease. Endoscopy. 2010;42 Suppl 2:E310-1. doi: 10.1055/s-0030-1255809. Epub 2010 Nov 26.

Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. Epub 2006 Jul 13.

Dunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25.

Kiesslich R, Goetz M, Lammersdorf K, Schneider C, Burg J, Stolte M, Vieth M, Nafe B, Galle PR, Neurath MF. Chromoscopy-guided endomicroscopy increases the diagnostic yield of intraepithelial neoplasia in ulcerative colitis. Gastroenterology. 2007 Mar;132(3):874-82. Epub 2007 Jan 31.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dolak W, Kiesewetter B, Müllauer L, Mayerhoefer M, Troch M, Trauner M, Häfner M, Raderer M, Püspök A. A pilot study of confocal laser endomicroscopy for diagnosing gastrointestinal mucosa-associated lymphoid tissue (MALT) lymphoma. Surg Endosc. 2016 Jul;30(7):2879-85. doi: 10.1007/s00464-015-4572-4. Epub 2015 Oct 20.

Responsible Party:	Werner Dolak, MD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT01583699 History of Changes
Other Study ID Numbers:	EK 111/2011
First Posted:	April 24, 2012
Last Update Posted:	July 21, 2015
Last Verified:	July 2015

Keywords provided by Werner Dolak, MD, Medical University of Vienna:

MALT-lymphoma; Confocal laser endomicroscopy; Gastrointestinal endoscopy

Additional relevant MeSH terms:

Lymphoma; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Non-Hodgkin; Stomach Neoplasms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders	Immune System Diseases; Lymphoma, B-Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases