Application of Carbon Nanoparticles in Laparoscopic Colorectal Surgery
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
The project aims to evaluate the safety, effectiveness, accuracy and economy efficiency of the application of carbon nanoparticles for tumor localization and lymph nodes mapping in the laparoscopic coloectal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2017
CompletedFirst Posted
Study publicly available on registry
November 22, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedNovember 22, 2017
November 1, 2017
1.7 years
November 5, 2017
November 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor localization time
From abdominal exploration to tumor localization
within 1 month
Secondary Outcomes (8)
survival data 1
within 5 year
survival data 2
within 5 year
Post-operative complication rates
within 6 month
Distal edge distance of specimen
within 2 weeks
LN number dissected
within 2-3 weeks
- +3 more secondary outcomes
Study Arms (3)
Device:Titanium Clips
ACTIVE COMPARATORDevice: Tumor localization. Preoperative endoscopic localization with titanium clips
Device:Intra-operative Endoscopy
ACTIVE COMPARATORDevice: Tumor localization. During the laparoscopic surgery,tumor is localized using intra-operative endoscopy detection.
Device:Carbon Nanoparticles
EXPERIMENTALDevice: Tumor localization. During the laparoscopic surgery,tumor is localized using carbon nanoparticles.
Interventions
At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing
Eligibility Criteria
You may qualify if:
- \- Pathologically diagnosed as colorectal benign tumor or tumor with TNM staging I-III (including patients need further surgery after endoscopic treatment), Be able to tolerate laparoscopic radical resection With normal hepatic and renal function No history of abdominal surgery
You may not qualify if:
- \- Patients with distant metastasis, poor compliance, prior abdominal surgery Emergency case with obstruction or perforation Have received neoadjuvant chemotherapy or radiotherapy Patients diagnosed as familial adenomatous polyposis (FAP), Inflammatory bowel disease such as ulcerative colitis and Crohn's disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aiguo, Lulead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Minhua Zheng
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 5, 2017
First Posted
November 22, 2017
Study Start
December 1, 2017
Primary Completion
August 1, 2019
Study Completion
December 31, 2019
Last Updated
November 22, 2017
Record last verified: 2017-11