Application of Carbon Nanoparticles in Laparoscopic Colorectal Surgery

NCT ID: NCT03350945

Last Updated: 2017-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Colorectal Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Device:Titanium Clips

Device: Tumor localization. Preoperative endoscopic localization with titanium clips

Group Type: ACTIVE_COMPARATOR

Device: tumor localization

Intervention Type: PROCEDURE

At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing

Device:Intra-operative Endoscopy

Device: Tumor localization. During the laparoscopic surgery,tumor is localized using intra-operative endoscopy detection.

Group Type: ACTIVE_COMPARATOR

Device: tumor localization

Intervention Type: PROCEDURE

At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing

Device:Carbon Nanoparticles

Device: Tumor localization. During the laparoscopic surgery,tumor is localized using carbon nanoparticles.

Group Type: EXPERIMENTAL

Device: tumor localization

Intervention Type: PROCEDURE

At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing

Interventions

Device: tumor localization

At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aiguo, Lu

OTHER

Sponsor Role: lead

Responsible Party

Aiguo, Lu

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Minhua Zheng

Role: STUDY_CHAIR

Ruijin Hospital

Central Contacts

di liu

Role: CONTACT

Phone: +8615601725597

Email: lydia_liu1991@163.com

Aiguo Lu

Role: CONTACT

Phone: 64370045

Email: lydia_liu1991@163.com

Other Identifiers

LAiguo

Identifier Type: -

Identifier Source: org_study_id