NIPH Clinical Trials Search

JRCT ID: jRCTs032230212

Registered date:10/07/2023


Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedRectal cancer
Date of first enrollment23/10/2023
Target sample size400
Countries of recruitment
Study typeInterventional
Intervention(s)Evaluation of blood flow by VPI, SPY PHI and SPY-QP Fluorescence Assessment Software.


Primary OutcomeAnastomotic leakage rate(Grade A+B+C)
Secondary OutcomeAnastomotic leakage rate(Grade B+C) Time to fluorescence at the most proximal colon which can be found under open procedure Tmax Relative value of fluorescent intensity at the transection line Rate of the additional transection Length of the additional transection of the proximal colon toward the oral side Rates of complications during surgery Rates of complications within 30 days after surgery Reoperation rate Postoperative hospital stay

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. Patients who are histologically proven to be rectal cancer 2. The lower edge of the tumor is within 12 cm from the anal verge 3. Patients diagnosed with Stage 0-3 in preoperative diagnostic imaging 4. Patients who are scheduled for rectal resectionwith intestinal anastomosis (including ISR, taTME) 5. Patients with General State Performance Status(ECOG) 0 to 2 6. Patients whose age at registration is 20 years or older 7. Patients whose functions of the main organs are adequately maintained and judged to be safe for surgery by the doctor in charge of examination within 28 days prior to the surgery. 8. About participation in this study Patients who have obtained consent from a document stating signature and date by the applicant
Exclude criteria1. Patients who are allergic to iodine orindocyanine green 2. Planned surgery is rectal resection with combined resection of adjacent organ 3. Preoperative intestinal obstruction patients 4. Patients planning simultaneous resection of other organs due to double cancer 5. Patients scheduled to anastomosis at more than two sites due to multiple colon cancer 6. Patients with intraperitoneal infection (peritonitis or abdominal abscess) 7. Patients with serious complications (heart disease, lung disease, bleeding tendency, poorly controlled hypertension, diabetes etc.) 8. Concerning females, pregnancy and patients with fear thereof 9. Other patients judged inappropriate by the examining physician

Related Information


Public contact
Name Atsushi Hamabe
Address 2-15, Yamadaoka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-5111
Affiliation Osaka University Hospital
Scientific contact
Name Jun Watanabe
Address Urafune 4-57, Minami-ku,Yokohama ,Kanagawa Kanagawa Japan 232-0024
Telephone +81-45-261-5656
Affiliation Yokohama City University Medical Center