臨床研究等提出・公開システム

An exploratory clinical trial to investigate the efficacy of the new fluorescence detection system 'Lumifinder' in fluorescence clip tumor marking for laparoscopic surgery of gastric and esophageal malignancies

A clinical trial to investigate the efficacy of the new fluorescence detection system in fluorescence clip tumor marking for gastric and esophageal malignancies

Hirano Satoshi

Hokkaido University Hospital

Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan

satto@med.hokudai.ac.jp

Wada Hideyuki

Hokkaido University Hospital

Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan

+81-11-716-1161

hi.hi.de0626@huhp.hokudai.ac.jp

Recruiting

Oct. 18, 2024

Interventional

single arm study

open(masking not used)

active control

single assignment

diagnostic purpose

1. Patients aged 18 years or older at the time of obtaining consent
2. Patients scheduled to undergo laparoscopic or thoracoscopic surgery (including robot-assisted surgery) under general anesthesia for the treatment of gastric cancer, esophago-gastric junction cancer, or esophageal cancer
3. Patients who have received sufficient explanation regarding participation in this study, fully understand it, and have given their consent of their own free will

Here is the English translation of the given text:

1. Patients with a history of gastrectomy or esophagectomy.
2. Patients with a history of upper abdominal surgery or other conditions that make them unsuitable for laparoscopic or thoracoscopic surgery.
3. Patients with a metal allergy.
4. Patients deemed unsuitable as research subjects by the principal investigator or co-investigator for other reasons.

Both

gastric cancer, esophago-gastric junction cancer, esophageal cancer

Tumor marking with a fluorescent clip under upper gastrointestinal endoscopy preoperatively and exploration of the fluorescent clip using the new fluorescence detection system

gastric cancer, esophago-gastric junction cancer, esophageal cancer

The feasibility of fluorescent measurement and position identification of Zemex FS Marker using Lumifinder

1. Differences in fluorescence intensity due to the location of the lesion and the thickness of either the gastric wall or the esophageal wall
2. Time required for fluorescence measurement and localization
3. Measurement of the oral or anal side margins of the tumor

+81-11-706-7934

Oct. 10, 2024

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