Rectal Cancer
Conditions
Keywords
locally advanced rectal cancer, lymph node yeild, lymph node tracer, stage shift, prognosis
Brief 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.
Interventions
PROCEDUREInjection CNP before NAT
Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy
Sponsors
YE Yingjiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Open label
Intervention model description
Parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-75 years old; 2. Histologically confirmed adenocarcinoma; 3. The rectal adenocarcinoma 0-12cm from the anal margin; 4. Clinical TNM stage: T3+ or N+; 5. Untreated patients (who have not received treatment including radiotherapy, chemotherapy, and surgery); 6. Good liver and kidney function, without contraindications for radiotherapy, chemotherapy or surgery; 7. Able and willing to give informed consent to participate;
Exclusion criteria
1. Malignant tumor history or other malignant tumors; 2. Emergency operations such as intestinal obstruction, perforation and hemorrhage; 3. Pregnant or lactating women; 4. History of severe mental illness; 5. Contraindications for radiotherapy, chemotherapy and surgery; 6. Conditions that the researcher thinks it is not suitable for selection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lymph node yield | up to 30days after total mesorectal excision | Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of surgery | Time of surgery | Quality of surgery determined using the mesorectal grading system |
| Surgery morbidity | 30 days and 12-months | Surgical morbidity reported according to Clavien-Dindo classification |
| Impact on surgical operations | Time of surgery | The impact of CNP to operational level |
| Disease free survival | 5-years | Disease Free Survival is defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death |
| Local recurrence rate | 5-years | Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence |
| Overall survival | 5-years | Overall Survival is defined as the time from the date of surgery to the date of death |
Contacts
Primary ContactYingjiang Ye, MD,PhD
Backup ContactZhidong Gao, MD
Outcome results
None listed