Safety and performance confirmation study with dMD-003

JRCT ID: jRCT2032240323

Registered date:10/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Metastatic liver cancer
• Date of first enrollment: 01/09/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): The study device (dMD-003) is applied, in principle, just under the wound (around the cut surface of the liver) immediately before wound closure in the initial surgery of a planned two-stage hepatectomy.

Outcome(s)

Primary Outcome

(1) Zuhlke classification
(2) TORAD score

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with bilobar multiple liver metastasis from colon or rectal cancer who are eligible for a hepatectomy only if a planned two-stage hepatectomy is used.
(2) Patients scheduled to undergo a second-stage hepatectomy at 2 to 12 weeks after the date of the initial hepatectomy.
Other criteria.

Exclude criteria

(1) Patients scheduled to undergo open resection along with the initial hepatectomy in the case of a concurrent primary colon or rectal tumor.
(2) Patients with a history of open surgery for a primary colon or rectal tumor.
(3) Patients who have previously undergone open surgery of the liver, bile duct, or upper abdomen.
Other criteria.

Related Information

• Primary Sponsor: Aihara Fumiaki