Clinical trial · Interventional
Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
A Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It is a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery aims to explore whether the application of near infrared-indocyanine green imaging system can evaluate the anastomotic blood perfusion accurately, and optimize the surgical procedures, or even reduce the incidence rates of postoperative anastomotic leakage in mid- or low- rectal cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| application of near infrared-indocyanine green imaging system | Procedure | — | UNRESOLVED |
| Non-application of near infrared-indocyanine green imaging system | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries.
- interventionNames
- Procedure: application of near infrared-indocyanine green imaging system
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience
- interventionNames
- Procedure: Non-application of near infrared-indocyanine green imaging system
Primary outcomes (1)
- measure
- Anastomotic leakage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * The age was over 18 years at the time of diagnosis; * Diagnosis of rectal carcinoma and was confirmed by preoperative pathology; * MRI was performed before operation, and the distance between the lower margin of tumor and the anal margin was no more than 10cm; * The colon-rectum or colon-anus anastomosis was performed by laparoscopic TME operation * The "spleen area" was not free during the operation * Baseline clinical tumor stage TNM Ⅰ-Ⅲ phase: cT1-4N0-2M0 (AJCC-8 version); Exclusion Criteria: * Allergic to ICG or iodine; * Patients with intestinal obstruction, intestinal perforation, intestinal bleeding who need emergency operation; * Patients requiring combined organ resection that the tumor involves adjacent organs; * Patients with recurrence of tumor or distant metastasis; * Patients with multiple colorectal cancer; * Patients with history of inflammatory bowel disease or familial adenomatous polyposis; * Patients who have participated in or are participating in other clinical trials in the past four weeks; * Patients that ASA level is larger than III; * Physical condition: Patients with KPS less than or equal to 60 points or ECOG larger than or equal to 2 points; * Patients with hepatic dysfunction and MELD larger than 12 points; * Patients with a history of serious mental illness; * Pregnant or lactating women; * Patients who are improper to participate in the study in the opinion of the researchers.
References
Publications (1)
- DERIVEDSun L, Gao J, Wu G, Meng C, Yang Z, Wei P, Yao H, Zhang Z. Perfusion outcomes with near-infrared indocyanine green imaging system in laparoscopic total mesorectal excision for mid-rectal or low-rectal cancer (POSTER): a study protocol. BMJ Open. 2024 May 9;14(5):e079858. doi: 10.1136/bmjopen-2023-079858. PMID 38724058