Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC
1. juni 2013 opdateret af: Yonsei University
Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial: KLASS-02-QC
Gastric cancer is one of the most common cancers in Korea.
Having achieved excellent long-term survival for early gastric cancer patients, there is a growing interest in improving the quality of life of these patients without compromising their prognosis.
Laparoscopic surgery for early gastric cancer have been found to be safe and feasible with superior short-term outcomes.
Although laparoscopic gastrectomy with D2 lymphadenectomy is being performed for patients with locally advanced gastric cancer; the completeness of the D2 lymphadenectomy during laparoscopic surgery has not been evaluate and no standardized procedure exists.
To conduct a clinical trial comparing laparoscopic D2 lymphadenectomy to the open approach, quality control of D2 lymphadenectomy procedure is necessary.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Forventet)
160
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Seoul, Korea, Republikken, 120-752
- Rekruttering
- Severance Hospital
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Kontakt:
- Woo Jin Hyung, MD, Ph.D
- Telefonnummer: 82-2-2228-2129
- E-mail: wjhyung@yuhs.ac
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Gastric cancer patients
Beskrivelse
Inclusion Criteria:
- Patients must have documented diagnosis of gastric cancer
- Patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by evaluation of preoperative CT-scan, upper endoscopy, or endoscopic ultrasound.
- Patients undergoing gastric cancer surgery without plans for combined operations, such as resection of another organ for another primary disease.
- Patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study
Exclusion Criteria:
- Patients without mental competence
- Patients who are illiterate
- Patients who are pregnant
- Patients < 20 and > 80 years old
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Laparoscopy group
Laparoscopy group: patients who underwent laparoscopic distal gastrectomy with D2 lymphadenectomy
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The commonly practice laparoscopic surgery for gastric cancer involves a partial omentectomy+D1+b lymphadenectomy which includes the dissection of Lymph node stations 1, 3, 4, 5, 6, 7, 8a, 9; however, when performing a D2 lymph node dissection, a total omentectomy plus LN1, 3, 4, 5, 6, 7, 8a, 9, 12a retrieval will be completed.
The same total omentectomy+D2 lymphadenectomy will also be performed by the open method.
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Open group
Open group: patients who underwent open distal gastrectomy with D2 lymphadenectomy
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The commonly practice laparoscopic surgery for gastric cancer involves a partial omentectomy+D1+b lymphadenectomy which includes the dissection of Lymph node stations 1, 3, 4, 5, 6, 7, 8a, 9; however, when performing a D2 lymph node dissection, a total omentectomy plus LN1, 3, 4, 5, 6, 7, 8a, 9, 12a retrieval will be completed.
The same total omentectomy+D2 lymphadenectomy will also be performed by the open method.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Evaluation of operative procedure according to predetermined criteria
Tidsramme: 6 months
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Predetermined criteria: exact dissection of lymph node (LN) station satisfying each requirements (omentum, LN1, LN3, LN4sb, LN4d, LN5, LN6, LN7, LN8a, LN9, LN11p and LN12a) |
6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.
- Kitano S, Shiraishi N, Fujii K, Yasuda K, Inomata M, Adachi Y. A randomized controlled trial comparing open vs laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer: an interim report. Surgery. 2002 Jan;131(1 Suppl):S306-11. doi: 10.1067/msy.2002.120115.
- Song KY, Kim SN, Park CH. Laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer: technical and oncologic aspects. Surg Endosc. 2008 Mar;22(3):655-9. doi: 10.1007/s00464-007-9431-5.
- Tokunaga M, Hiki N, Fukunaga T, Nohara K, Katayama H, Akashi Y, Ohyama S, Yamaguchi T. Laparoscopy-assisted distal gastrectomy with D2 lymph node dissection following standardization--a preliminary study. J Gastrointest Surg. 2009 Jun;13(6):1058-63. doi: 10.1007/s11605-009-0840-8. Epub 2009 Mar 7.
- Hur H, Lee HY, Lee HJ, Kim MC, Hyung WJ, Park YK, Kim W, Han SU. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial. BMC Cancer. 2015 May 5;15:355. doi: 10.1186/s12885-015-1365-z.
- Kim HI, Hur H, Kim YN, Lee HJ, Kim MC, Han SU, Hyung WJ. Standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC): a prospective, observational, multicenter study [NCT01283893]. BMC Cancer. 2014 Mar 19;14:209. doi: 10.1186/1471-2407-14-209.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2010
Primær færdiggørelse (Forventet)
1. august 2013
Studieafslutning (Forventet)
1. august 2013
Datoer for studieregistrering
Først indsendt
24. januar 2011
Først indsendt, der opfyldte QC-kriterier
25. januar 2011
Først opslået (Skøn)
26. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4-2010-0637
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 Mavekræft
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, GastricForenede Stater
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Medtronic - MITGAfsluttet
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Olympus Corporation of the AmericasUnity Health TorontoAfsluttet
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetRoux en Y Gastric BypassForenede Stater
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Rijnstate HospitalAfsluttetRoux-en-Y Gastric Bypass | Mavetømning | Bariatrisk kirurgiHolland
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Rijnstate HospitalAfsluttet
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetSleeve Gastrectomy | Roux en Y Gastric BypassForenede Stater
Kliniske forsøg med Laparoscopic distal gastrectomy with D2 lymphadenectomy
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National Cancer Center, KoreaSamsung Medical Center; Seoul National University Hospital; Seoul National... og andre samarbejdspartnereUkendtMavekræftKorea, Republikken
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Southwest Hospital, ChinaThe First Affiliated Hospital of Nanchang University; Sun Yat-sen University og andre samarbejdspartnereUkendt