Safety Evaluation of Cytoreductive Surgery for Colorectal Peritoneal Metastases

JRCT ID: jRCT1030230662

Registered date:27/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Colorectal Peritoneal metastases
• Date of first enrollment: 01/04/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Cytoreductive Surgery

Outcome(s)

• Primary Outcome: Incidence of severe perioperative adverse event (Clavien-Dindo Grade 3)
• Secondary Outcome: Incidence of perioperative adverse events, Incidence of intraoperative adverse events, Percentage of complete removable of visible peritoneal disease, Overall survival, Relapse-free survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

Histologically confirmed colorectal adenocarcinoma
Clinical diagnosis of colorectal peritoneal metastases
Peritoneal cancer index no more than 20
Peritoneal disease within surgically removable range
Age between 20 and 75 years old
ECOG performance status of 0 or 1
Written informed consent with sufficient understanding

Exclude criteria

Uncontrollable distant metastases
Inability to endure cytoreductive surgery under general anesthesia
Coagulation abnormalities
Psychiatric impairment
Pregnancy, possible pregnancy, or breastfeeding

Related Information

• Primary Sponsor: Kanemitsu Yukihide