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Feasibility study of photodynamic diagnosis using 5-aminolaevulinic acid during endoscopic submucosal dissection for early gastric cancer

Feasibility study of photodynamic diagnosis using 5-aminolaevulinic acid during endoscopic submucosal dissection for early gastric cancer - PDD using 5ALA for early gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027996
Enrollment
20
Registered
2017-07-07
Start date
2017-07-07
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

Early gastric cancer

Interventions

Before endoscopic submucosal dissection, 20 mg/m2 of 5-aminolevulinic acid solution was given orally. After tumor resection, resected specimens were investigated by an endoscopic phododynamic diagnosi

Sponsors

Kochi Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. An age of 20 years and over. 2. Histologically proven intestinal type gastric adenocarcinoma including papillary, well and moderate differentiated adenocarcinoma. 3. A performance status of 0-1 accord ing to the Eastern Cooperative Oncol ogy Group (ECOG) scale. 4. Adequate organ function including heart, lung, liver, kidney and bone marrow function in addition to clinical laboratory results. 5. Patients without synchronous or metachronous malignant disease, or multicentric cancer. 6. All patients gave written informed consent. 9. All patients gave written

Exclusion criteria

Exclusion criteria: 1. Uncontrollable infectious disease including active tuberculosis. 2. Serious concurrent disease such as malignant hypertension, severe congestive heart failure, severe coronary ischemic disease, acute myocardial infarction, terminal liver cirrhosis, severe renal insufficiency, dialysis patients, uncontrollable diabetes mellitus, severe pulmonary fibrosis, interstitial pneumonia and so on. 3. Patients received bone marrow transplantation. 4. Patients with psychosomatic disorder. 5. Patients with porphyria or hypersensitivity to porphyrins allergy. 6. Women who are pregnant or hope to become pregnant during the study period. 7. Patients judged inappropriate for t he study by their physicians.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy

Secondary

MeasureTime frame
Adverse events

Countries

Japan

Contacts

Public ContactTsutomu Namikawa Tsutomu Namikawa

Kochi Medical School Department of Surgery

tsutomun@kochi-u.ac.jp+81-88-880-2370

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026