臨床研究等提出・公開システム

A multicenter, prospective, single-arm, study on the usefulness of blood flow evaluation of anastomotic site using the SPY-QP software system in rectal cancer minimally invasive surgery.

SPECTACLE study

Watanabe Jun

Kansai Medical University Hospital

Shinmachi 2-3-1, Hirakata ,Osaka

watanabe.jun@kmu.ac.jp

Hamabe Atsushi

The University of Osaka Hospital

2-15, Yamadaoka, Suita, Osaka

+81-6-6879-5111

ahamabe@gesurg.med.osaka-u.ac.jp

Not Recruiting

July. 10, 2023

Interventional

single arm study

open(masking not used)

historical control

single assignment

diagnostic purpose

1. 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

1. 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

Both

Rectal cancer

Evaluation of blood flow by VPI, SPY PHI and SPY-QP Fluorescence Assessment Software.

Anastomotic leakage rate(Grade A+B+C)

Anastomotic 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

+81-45-370-7627

June. 13, 2023

none