JRCT ID: jRCT1042250150
Registered date:22/12/2025
FLUCLIP study
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Gastric cancer |
| Date of first enrollment | 03/03/2026 |
| Target sample size | 50 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Near-infrared fluorescent marking clips are placed near the tumor by preoperative endoscopy |
Outcome(s)
| Primary Outcome | The distance between the point where the fluorescent marking clip was observed and the oral side edge of the tattoo spot (mm) |
|---|---|
| Secondary Outcome | Percentage of patients with at least one visible fluorescent marking clip Percentage of patients with two clips remained on stomach specimen Percentage of patients who would undergo Roux-en-Y reconstruction if the stomach was dissected at the oral margin of the tattoo, but would undergo reconstructed Billoth I reconstruction if the stomach was dissected at the location of the fluorescent marking clips Percentage of patients who would undergo total gastrectomy if the stomach was dissected at the oral margin of the tattoo Percentage of patients with a negative pathological proximal margin for cancer Percentage of patients for whom cancer was negative on the line connecting the two clip placement sites (the sites judged as cancer-negative by preoperative endoscopy) Incidence of intraoperative complications Incidence of complications within 30 days postoperatively Incidence of adverse events (associated with the use of fluorescent marking clips) Number of days of postoperative hospital stay |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | For patients with primary gastric cancer scheduled for robot-assisted distal gastrectomy using da Vinci Xi |
| Exclude criteria | Have a severe allergy to metals |
Related Information
| Primary Sponsor | Bando Etsuro |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Kenichiro Furukawa |
| Address | 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777 |
| Telephone | +81-55-989-5222 |
| ke.furukawa@scchr.jp | |
| Affiliation | Shizuoka Cancer Center |
| Scientific contact | |
| Name | Etsuro Bando |
| Address | 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777 |
| Telephone | +81-55-989-5222 |
| e.bando@scchr.jp | |
| Affiliation | Shizuoka Cancer Center |