Evaluation of the usefulness of endocytoscopy for diagnosis of gastric MALT lymphoma before and after treatment

Study of usefulness of diagnosis of MALT lymphoma using endocytoscopy before and after treatment - MALTEC study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045076

Enrollment

Registered

2021-08-10

Start date

2021-01-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric MALT lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients before treatment of MALT lymphoma and who is scheduled detailed examination and biopsy or patients after initial treatment of MALT lymphoma and who is scheduled detailed examination and biopsy. Patients who are explained adequately about this research and can understand enough and assume and agree by patient's free will.

Exclusion criteria

Exclusion criteria: Patients that performing endocytoscopy affect after examination and treatment. Patients who have allergy of methylene blue or crystal violet. Patients who are forbidden biopsy. Patients whom researcher estimates inadequate for this research.

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of endocytoscopic images by 3 doctors who don't perform endocytoscopy (all images and biopsy)	—

Secondary

Measure	Time frame
1:Sensitivity, specificity, positive predictive value, negative predictive value of biopsy with endocytoscopy. 2:Accuracy, sensitivity, specificity, positive predictive value, negative predictive value of biopsy with endocytoscopy by whom perform endocytoscopy. 3:Accuracy of diagnosis of magnified encoscopy. 4:Concordance rate of diagnosis using images of endocytoscopy and magnified endoscopy by three doctors who don't perform endocytoscopy 5:Correlation of numbers of cells and glands in images by using endocytoscopy and magnified endoscopy 6:Cor0relation of numbers of cells and glands in images between endocytoscopy and histopathology. We define ECM3 and Wotherspoon grade 4-5 as existing MALT lymphoma. We difine ECM1 and GELA pMRD and ChR as remission of MALT lymphoma.	—

Measure

Time frame

1:Sensitivity, specificity, positive predictive value, negative predictive value of biopsy with endocytoscopy. 2:Accuracy, sensitivity, specificity, positive predictive value, negative predictive value of biopsy with endocytoscopy by whom perform endocytoscopy. 3:Accuracy of diagnosis of magnified encoscopy. 4:Concordance rate of diagnosis using images of endocytoscopy and magnified endoscopy by three doctors who don't perform endocytoscopy 5:Correlation of numbers of cells and glands in images by using endocytoscopy and magnified endoscopy 6:Cor0relation of numbers of cells and glands in images between endocytoscopy and histopathology. *We define ECM3 and Wotherspoon grade 4-5 as existing MALT lymphoma. *We difine ECM1 and GELA pMRD and ChR as remission of MALT lymphoma.

—

Countries

Japan

Contacts

Public ContactHiroki Egami

Hokkaido University Hospital Division of Endoscopy

kyokui090060@gmail.com+81-11-716-1161

Outcome results