An interventional study of Injection CNP before NAT in Rectal Cancer, sponsored by YE Yingjiang. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-06-08.
Sponsored by YE Yingjiang · Not applicable, Interventional, and Other
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 252 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →YE Yingjiang is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.
Procedure: Injection CNP before NAT
Do not inject carbon nanoparticle during the treatment.
Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy
lymph node yield
Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node
Time frame: up to 30days after total mesorectal excision
Impact on surgical operations
The impact of CNP to operational level
Time frame: Time of surgery
Quality of surgery
Quality of surgery determined using the mesorectal grading system
Time frame: Time of surgery
Surgery morbidity
Surgical morbidity reported according to Clavien-Dindo classification
Time frame: 30 days and 12-months
Overall survival
Overall Survival is defined as the time from the date of surgery to the date of death
Time frame: 5-years
Disease free survival
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
Time frame: 5-years
Local recurrence rate
Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence
Time frame: 5-years
No study locations are listed for this record.
Plan to share: Undecided — We need to discuss with other centers, then decide whether to share IPD
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
YE Yingjiang