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- Essai clinique NCT03350945
Application of Carbon Nanoparticles in Laparoscopic Colorectal Surgery
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Device:Titanium Clips
Device: Tumor localization.
Preoperative endoscopic localization with titanium clips
|
At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing
|
|
Comparateur actif: Device:Intra-operative Endoscopy
Device: Tumor localization.
During the laparoscopic surgery,tumor is localized using intra-operative endoscopy detection.
|
At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing
|
|
Expérimental: Device:Carbon Nanoparticles
Device: Tumor localization.
During the laparoscopic surgery,tumor is localized using carbon nanoparticles.
|
At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tumor localization time
Délai: within 1 month
|
From abdominal exploration to tumor localization
|
within 1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
survival data 1
Délai: within 5 year
|
overall survival
|
within 5 year
|
|
survival data 2
Délai: within 5 year
|
disease free survival
|
within 5 year
|
|
Post-operative complication rates
Délai: within 6 month
|
According to the records in hospital
|
within 6 month
|
|
Distal edge distance of specimen
Délai: within 2 weeks
|
measured by two pathologists separately
|
within 2 weeks
|
|
LN number dissected
Délai: within 2-3 weeks
|
measured by two pathologists separately
|
within 2-3 weeks
|
|
Length of stay
Délai: within a year
|
According to the record in hospital
|
within a year
|
|
Total operation time
Délai: within 1 week
|
Measured according to operation record
|
within 1 week
|
|
Blood loss
Délai: within 1 week
|
Measured according to operation record
|
within 1 week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Minhua Zheng, Ruijin Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LAiguo
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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