Exploratory clinical trial on intraoperative intestinal blood flow assessment using ultrasound doppler technique

JRCT ID: jRCTs032240428

Registered date:23/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 23/10/2024
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Evaluation of blood flow in the intestinal wall using ultrasound doppler technique before anastomosis during colorectal cancer surgery.

Outcome(s)

• Primary Outcome: Difference in blood flow boundary between ultrasound doppler method and ICG method

Secondary Outcome

<Secondary endpoints of efficacy>
Reproducibility of ultrasound doppler method

<Secondary endpoints of safety>
Incidence of intraoperative adverse events Adverse events within 30 days after surgery Postoperative hospital stay

Key inclusion & exclusion criteria

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

Include criteria

1) Patients who are histologically proven to be col orectal cancer
2) Patients undergoing colorectal cancer surgery with gastrointestinal anastomosis
3) Patients whose age at registration is 20 years or older
4) Patients with General State Performance Status (ECOG) 0 to 2
5) Patients whose functions of the main organs are adequately maintained and judged to be safe for surgery by the doctor incharge of examination
6) Patients who have received sufficient explanations about participation in this study and have giv en written consent of their own
free will with sufficient understanding.

Exclude criteria

1) Patients with a history of allergy to ICG or iodine hypersensitivity
2) Pregnant, possibly pregnant, within 28 days pos tpartum, breastfeeding
3) Other patients judged inappropriate by the exa mining physicia

Related Information

• Primary Sponsor: Hirata Atsushi
• Secondary Sponsor: Matsubara Hisahiro
• Source(s) of Monetary Support: Chiba University Hospital