SPECTACLE study

JRCT ID: jRCTs032230212

Registered date:10/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 23/10/2023
• Target sample size: 400
• Study type: Interventional
• Intervention(s): Evaluation of blood flow by VPI, SPY PHI and SPY-QP Fluorescence Assessment Software.

Outcome(s)

• Primary Outcome: Anastomotic leakage rate(Grade A+B+C)

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Watanabe Jun
• Secondary Sponsor: Uemura Mamoru