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Application of Carbon Nanoparticles in Laparoscopic Colorectal Surgery

18. november 2017 oppdatert av: Aiguo, Lu
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.

Studieoversikt

Status

Ukjent

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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
Aktiv komparator: 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
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tumor localization time
Tidsramme: within 1 month
From abdominal exploration to tumor localization
within 1 month

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studiestol: Minhua Zheng, Ruijin Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. desember 2017

Primær fullføring (Forventet)

1. august 2019

Studiet fullført (Forventet)

31. desember 2019

Datoer for studieregistrering

Først innsendt

5. november 2017

Først innsendt som oppfylte QC-kriteriene

18. november 2017

Først lagt ut (Faktiske)

22. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. november 2017

Sist bekreftet

1. november 2017

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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