Clinical trial · Interventional
Endomicroscopy and Gastric MALT-lymphoma
Confocal Laser Endomicroscopy as Diagnostic Tool for Gastrointestinal MALT-lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MALT-lymphoma | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal Laser Endomicroscope | Device | — | UNRESOLVED |
| Confocal laser endomicroscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endomicroscopy
- description
- All patients included into the study will undergo endomicroscopy of the upper GI-tract.
- interventionNames
- Procedure: Confocal laser endomicroscopy
- Device: Confocal Laser Endomicroscope
Primary outcomes (1)
- measure
- Qualitative MALT-features on Endomicroscopy
- timeFrame
- 2 years
- description
- Establishing endomicroscopic features of MALT-lymphoma in the upper gastrointestinal tract. This outcome is a qualitative endpoint that will be assessed only descriptively.
Secondary outcomes (1)
- measure
- Sensitivity and Specificity of Endomicroscopy to diagnose GI-MALT-Lymphoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (19)
- BACKGROUNDOtt 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. PMID 19669189
- BACKGROUNDFerreri AJ, Zucca E. Marginal-zone lymphoma. Crit Rev Oncol Hematol. 2007 Sep;63(3):245-56. doi: 10.1016/j.critrevonc.2007.04.009. Epub 2007 Jun 20. PMID 17583528
- BACKGROUNDMorgner 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. doi: 10.3748/wjg.v13.i26.3554. PMID 17659705
- BACKGROUNDZullo 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. PMID 19532131
- BACKGROUNDTerai 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. doi: 10.1620/tjem.214.79. PMID 18212490
- BACKGROUNDRaderer 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. doi: 10.1586/14737140.1.1.53. PMID 12113133
- BACKGROUNDRaderer 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. doi: 10.1158/1078-0432.CCR-04-2282.