A clinical trial to evaluate the usefulness of intraoperative intestinal blood f low assessment using an endoscope for the gastrointestinal tract

JRCT ID: jRCTs032220010

Registered date:08/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal Cancer
• Date of first enrollment: 08/04/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Observation of the serous surface of the colon usin g an endoscope before anastomosis in colorectal cancer surgery

Outcome(s)

• Primary Outcome: Difference in blood flow boundary between ICG m ethod and this method (mm)

Secondary Outcome

Secondary endpoints of efficacy
Time to identify the blood flow boundary between this method and ICG method
Relationship between the following factors and th e difference in the blood flow boundary between t his method and the ICG method
Approach method (laparotomy, laparoscopy, rob ot-assisted)
Operative time to assess blood flow
Amount of blood loss until blood flow assessment
Resected bowel length
Site of treated vessel
Site of blood flow assessment intestine
Presence of intestinal edema
Endoscope used
Attenuation width of blood flow boundary in this method
Attenuation width of blood flow boundary in ICG method
Speed of red blood cells in the area with blood flow
Speed of red blood cells in the attenuation zone of this method
Distance from mesenteric resection to blood flow border in this method
Fluorescence speed at the attenuation zone in the ICG method
Fluorescence intensity at the blood flow border in the ICG method
Fluorescence intensity of the attenuation zone at the border of the blood flow in the ICG method
Drugs used during blood flow assessment
Blood pressure, heart rate, and arterial oxygenation at the time of blood flow assessment
Pathological results of tumor

Secondary endpoints of safety
Incidence of intraoperative adverse events Relationship between adverse events within 30 da ys after surgery and blood flow assessment by this method
Postoperative hospital stay

Exploratory endpoints
Relationship between FT and the difference in blo od flow boundary between this method and the ICG method
Relationship between the difference of blood flow boundary between this method and ICG method a nd suture failure rate
Observation results of the area where delayed blo od flow was confirmed by ICG method.

Key inclusion & exclusion criteria

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

Include criteria

Patients who meet all of the following conditions a re eligible.
(1) Patients undergoing colorectal cancer surgery with gastrointestinal anastomosis
(2) Patients must be 20 years of age or older at the time of consent.
(3) Patients whose major organs are functioning a dequately and who are judged by the investigator to be able to undergo surgery safely.
(4) Patients who have received sufficient explanati ons about participation in this study and have give n written consent of their own free will with suffici ent understanding.

Exclude criteria

Patients who meet any of the following conditions are not eligible for the study.
(1) Patients with a history of allergy to ICG or iodin e hypersensitivity
2) Patients with preoperative intestinal obstruction
3) Patients who have received preoperative treatm ent (e.g., anticancer drug therapy, radiotherapy, c olorectal stent)
4) Patients who are scheduled to have two or mor e anastomoses
5) Patients with infection in the abdominal cavity 6) Patients with serious comorbidities (cardiac dis ease, pulmonary disease, autoimmune disease, ble eding tendency, poorly controlled hypertension or diabetes, etc.)
7) Pregnant patients
8) Patients who are considered inappropriate for participation in the study by the principal investig ator or sub-investigator.

Related Information

• Primary Sponsor: Matsubara Hisahiro
• Secondary Sponsor: Chiba University Clinical Research Promotion Division