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Randomized phase 3 trial evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of rectal cancer.

Randomized phase 3 trial evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of rectal cancer. - EssentiAL study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030240
Enrollment
850
Registered
2018-04-01
Start date
2018-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Evaluation of blood flow by near infrared imaging using indocyanine green control

Sponsors

Sapporo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 margin 3. Patients diagnosed with Stage 0-3 in preoperative diagnostic imaging 4. Patients who are scheduled for rectal resection with intestinal anastomosis (including ISR) 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 1 White blood cell count> 3,000 / mm 3 2 platelet> 100,000 / mm 3 3 GOT <100 IU / L 4 GPT <100 IU / L 5 Total bilirubin <2.0 mg / dl 6 Cr <2.0 mg / dl 8. About participation in this study Patients who have obtained consent from a document stating signature and date by the applicant

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to iodine or indocyanine green 2. Preoperative intestinal obstruction patients 3. Patients planning simultaneous resection of other organs due to double cancer 4. Patients scheduled to anastomosis at more than two sites due to multiple colon cancer 5. Patients with intraperitoneal infection (peritonitis or abdominal abscess) 6. Patients with serious complications (heart disease, lung disease, bleeding tendency, poorly controlled hypertension, diabetes etc.) 7. Pregnancy and patients with fear thereof 8. Other patients judged inappropriate by the examining physician

Design outcomes

Primary

MeasureTime frame
Anastomotic leakage rate

Secondary

MeasureTime frame
Anastomotic leakage rate(Grade B+C) Fluorescence time at the oral side anastomotic site Rate of the additional transection of the proximal colon toward the oral side Length of the additional transection of the proximal colon toward the oral side Rates of complications within 30 days after surgery Rates of complications during surgery Reoperation rate Postoperative hospital stay

Countries

Japan

Contacts

Public ContactJun Watanabe

Yokohama City University Medical Center Department of surgery

jun0926@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026