Application of Carbon Nanoparticles in Laparoscopic Colorectal Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Tumor
• Intervention / Treatment: Procedure: Device: tumor localization

Detailed Description

Colorectal cancer is among the most commonly diagnosed cancer in both men and women . Increasing studies have been focused on the causes and therapies of this disease in order to improve the prognosis. In recent decades, laparoscopy has been commonly used in both colorectal and gastric surgery due to the benefit of minimal invasive technology progression . Its comparable safety and effectiveness have been proved in many studies. The advantages of minimal invasive surgery such as faster recovery, less bleeding and less pain, have also been admitted by numerous surgeons . However, the accomplishment of operation procedures mainly depend on subjective experiences. Even skilled surgeons can be impeded in operation due to the deficiency of tactile sense . As a result, accurate intra-operative localization of tumor would be a tough task if it was invisible on the serosal surface or difficult to approach, such as small or flat neoplasms, tumor confined to the mucosa and submucosa and endoscopically resected polyps which required additional surgery . At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing. All of these methods have their advantages but also some unavoidable limitations, such as localization error and problems in the assessment of incision margin using preoperative clip placement, unsatisfactory operation exposure after intraoperative endoscopy, ink spillage or failure in finding lesions with dye endoscopic injection et al. Usually surgeons choose different methods according to the objective conditions such as the ability to perform endoscopy or the availability of suitable tattooing material.

Apart from the precise localization of tumor, adequate lymph node dissection is another crucial point in colorectal operation. According to AJCC recommendation and NCCN guideline, the number of lymph nodes, which has been proved of prognostic and therapeutic importance, is clearly defined in colorectal cancer to make sure of the accurate pathological staging. Previous studies have found that the number of lymph nodes evaluated after surgical resection was positively associated with the survival of patients. Besides Total Mesorectal Excision (TME) and D3 lymph node clearance, which are standards in colorectal surgery over decades of research and accumulated data, the harvest of lymph nodes is still associated with pathological doctors' experience and pathological examination skills. However, population-based data suggest that lymph node evaluation is not adequate in the majority of patients . Some micro lymph nodes, especially with diameter less than 5 mm, are more easily missed in specimen process while rate of metastasis is comparably higher in these lymph nodes. As a result, clinicians are trying to find a lymph node tracer to help improve the amount of lymph node harvest as well as the rate of micro-metastasis in lymph node.

Carbon nanoparticle has been used as a lymph node tracer for decades. As a lymphatic vessel specific dye material, there is no doubt in its effect on lymph node mapping. In recent years, surgeons have applied this tracer widely in breast and thyroid operations for sentinel lymph node mapping to determine dissection extent. The effectiveness and accuracy of this method has been verified in thyroid and breast surgery while there is rare study focused on its application in colorectal surgery. The application of tattooing material, such as methylene blue, India ink and nano-materials in tumor localization has also attracted attentions of clinicians. In our study, three groups based on different tumor localization means are compared on short-term benefits, cost-effectiveness and lymph node clearance in order to choose the best approach to locate tumor and validate lymph node staining effect of carbon nanoparticles.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Device:Titanium Clips; Device: Tumor localization. Preoperative endoscopic localization with titanium clips	Procedure: Device: tumor localization; At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing
Active Comparator: Device:Intra-operative Endoscopy; Device: Tumor localization. During the laparoscopic surgery,tumor is localized using intra-operative endoscopy detection.	Procedure: Device: tumor localization; At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing
Experimental: Device:Carbon Nanoparticles; Device: Tumor localization. During the laparoscopic surgery,tumor is localized using carbon nanoparticles.	Procedure: Device: tumor localization; At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor localization time	From abdominal exploration to tumor localization	within 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival data 1	overall survival	within 5 year
survival data 2	disease free survival	within 5 year
Post-operative complication rates	According to the records in hospital	within 6 month
Distal edge distance of specimen	measured by two pathologists separately	within 2 weeks
LN number dissected	measured by two pathologists separately	within 2-3 weeks
Length of stay	According to the record in hospital	within a year
Total operation time	Measured according to operation record	within 1 week
Blood loss	Measured according to operation record	within 1 week

Collaborators and Investigators

• Sponsor: Aiguo, Lu
• Investigators: Study Chair: Minhua Zheng, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 5, 2017
• First Submitted That Met QC Criteria: November 18, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 18, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: LAiguo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No