Clinical trial · Interventional
Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253
Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253 of Rectal and Sigmoid Colon Carcinoma
NCT04848311CI-TRIAL-00051337unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a prospective randomized controlled study. investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group to compare the differences of lymph nodes dissection in station 253 between the two groups.
Conditions
Conditions (2)
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 Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Sigmoid Colon Carcinoma | Sigmoid Colon Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lymph nodes dissection at 253 station assisted by ICG | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ICG group
- description
- Patients in the ICG group will undergo endoscopic injection of ICG 4 hours before surgery. The ICG powder will be dissolved in 2.5mg/ml of sterile water. ICG will be injected along the submucosa at 4 points around the primary tumor,for a total volume of 10ml.
- interventionNames
- Procedure: lymph nodes dissection at 253 station assisted by ICG
- type
- NO_INTERVENTION
- label
- CLgroup
- description
- Patients in the CL group will undergo routine laparoscopic lymph nodes dissection instead of using any tracer.
Primary outcomes (1)
- measure
- number of harvested station 253 lymph nodes
- timeFrame
- one week after operation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: (1)18-80 years of age (2)American Society of Anesthesiologists (ASA) class 1-3 (3)single rectal or sigmoid colon carcinoma confirmed pathologically by endoscopic biopsy (4)planned laparoscopic radical resection (5)Written informed consent Exclusion Criteria: 1. previous abdominal tumor surgery 2. women who are pregnant or breast feeding 3. emergency patients with obstruction or perforation 4. T4b cancer evaluated by CT or MRI or endoscopic ultrasonography 5. pelvic or distant metastasis 6. T1 cancer planned local excision 7. allergic constitution patients
References
Publications (1)
- DERIVEDWan J, Wang S, Yan B, Tang Y, Zheng J, Ji H, Hu Y, Zhuang B, Deng H, Yan J. Indocyanine green for radical lymph node dissection in patients with sigmoid and rectal cancer: randomized clinical trial. BJS Open. 2022 Nov 2;6(6):zrac151. doi: 10.1093/bjsopen/zrac151. PMID 36515673