- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03708783
Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC
Study on Short and Long-term Outcome of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Radical resection is the primary treatment for patients with advanced middle or upper third gastric cancer. And D2 lymphadenectomy, including No. 10 lymph node dissection, should be performed according to the Japanese treatment guidelines for gastric cancer. Because of the complexity of the anatomy around the spleen, spleen-preserving No. 10 lymph node dissection is difficult. Although Professor Huang from Fujian Medical University Union Hospital has proposed the "Huang's three-step maneuver" to dissect No. 10 lymph node with preserved spleen laparoscopically, such method is far from popularized, especially in North China. In addition, the safety, feasibility and oncological efficacy of this method was not confirmed in such area, either.
In this study, a prospective, single center, single-arm, non-inferiority clinical trial will be conducted to evaluate the short and long-term outcome of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced middle or upper third gastric cancer in Beijing.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Zaozao Wang
- Telefonnummer: 0086-10-88196851
- E-mail: zaozao83630@sina.com
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
-
Kontakt:
- Xiangqian Su
- Telefonnummer: 0086-10-88196696
- E-mail: suqiangqian@bjmu.edu.cn
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients age older than 18 years (including 18 years old);
- The primary lesion is located in the upper or middle third of the stomach, including Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction;
- Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell and poorly differentiated adenocarcinoma);
- Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging);
- The Eastern Cooperative Oncology Group performance status of 0 or 1;
- The American Society of Anesthesiology classes of I, II or III;
- Signed Informed consent.
Exclusion Criteria:
- Pregnant or lactating women;
- Suffering from severe mental disorder;
- Previous gastrectomy, including endoscopic submucosal dissection and endoscopic mucosal resection;
- Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes;
- Siewert I type adenocarcinoma of the esophagogastric junction;
- Other malignant diseases (within 5 years);
- Other illnesses needed operation concurrently;
- Complications (bleeding, perforation or obstruction) required emergency surgery due to primary gastric malignancy;
- Pulmonary function tests FEV1 less than 50% of predicted value;
- Patient suffered from bleeding tendency disease such as hemophilia or took anti-coagulant medication due to deep vein thrombosis.
- Patients with obvious tumor infiltration in the spleen and splenic vessels which require splenectomy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: No. 10 Lymph Node Dissection group
Patients with locally advanced upper or middle third gastric cancer will receive laparoscopic total gastrectomy and D2 lymphadenectomy with spleen-preserving No.10 lymph node dissections
|
For patients with locally advanced upper or middle third gastric cancer, laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-preserving No. 10 lymph node dissection is performed.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
the incidence of postoperative complications within 30 days
Tidsramme: 30 days
|
30 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
3-year disease free survival
Tidsramme: 36 months
|
36 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CFH2018-2-2153
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Laparoskopisk kirurgi
-
Assistance Publique Hopitaux De MarseilleUkendt
-
Universiti Putra MalaysiaNational Cancer Institute (NCI)AfsluttetFast Track Recovery SurgeryMalaysia
-
Karolinska InstitutetErsta Hospital, SwedenAfsluttetLoopileostomi | Fast Track-program, (Enhanced Recovery After Surgery (ERAS))Sverige
-
University of PittsburghTrukket tilbagePostoperativ smerte | Abdominal Body Contouring SurgeryForenede Stater
-
Kahramanmaras Sutcu Imam UniversityIkke rekrutterer endnuPostoperativ smerte | Erector Spinae Plane Block i Spinal Surgery
-
Ridho Ardhi SyaifulAfsluttetKolorektale neoplasmer | Kolorektal cancer | Kolorektal kirurgi | Enhanced Recovery After Surgery (ERAS) protokol | EffektivitetIndonesien
-
University of MichiganRekrutteringObstruktiv søvnapnø | Maxillomandibular Advancement SurgeryForenede Stater
-
Philipps University Marburg Medical CenterAfsluttetKoronar hjertesygdom | Patienternes forventninger | Koronararterie Bypass Graft Surgery (CABG)Tyskland
-
Odense University HospitalRekrutteringAdipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric SurgeryDanmark
-
Istituto Clinico HumanitasUkendtLungekræft | Robotisk thoraxkirurgi | Video-assisteret Thoracis Surgery (VATS) | Åben Thorakotomi kirurgiItalien