Trials / Unknown
UnknownNCT03550001
Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy
Prospective Randomized Clinical Trial of Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- Sponsor
- YE Yingjiang · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate whether injection of carbon nanoparticle as a lymph node tracer before neoadjuvant radiochemotherapy in rectal cancer can increase lymph node yield after surgery compared which do not inject.
Detailed description
This is the randomized controlled, multi-centers，and open-labeled study. The lymph node yield was significantly decreased in rectal cancer after neoadjuvant radiochemotherapy (NAT), hard for pathologists to detect, and is difficult to meet the guideline that minimun of 12 lymph nodes should be retrived after surgery in colorectal cancer. Carbon nanoparticle (CNP) is a specific lymph node tracer, which only dyeing the lymph node, and can keep the lymph node in dyeing state in at least half year. The inverstigator attempted to compare the amount of lymph node yield after surgery in locally advanced rectal caner between injection CNP before NAT and no injection CNP before NAT. In this study, the participants with clinical TNM stage T3+ or N+ will be recruited. The participants will be randomized (1:1 ratio) to a control and intervention arm. The participants in the control arm will not receive injection of any kind lymph node tracers. The participants in the intervention arm will receive injection of CNP before NAT. And the specimen would be evaluated by the pathologist.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Injection CNP before NAT | Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2019-06-01
- Completion
- 2023-10-01
- First posted
- 2018-06-08
- Last updated
- 2018-06-08
Source: ClinicalTrials.gov record NCT03550001. Inclusion in this directory is not an endorsement.