- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00546468
Clinical Study on Laparoscopic Gastrectomy for Early Gastric Cancer (COACT_0301) (NCC052)
Prospective Randomized Trial of Laparoscopy-assisted Distal Gastrectomy (LADG) Versus Open Distal Gastrectomy (ODG) in Patients With Early Gastric Cancer (EGC)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Randomization
Randomization is done by person who is not involved in study. So it is done by the person in Center for Clinical Trial in National Cancer Center. The patient is enrolled in the out-patient clinic after getting informed consent of the clinical study from the patient. Surgeon factor is not considered as a randomization factor because this clinical study will be performed intramurally. In Center for Gastric Cancer, National Cancer Center, Surgical techniques and extent of resections are generally standardized and surgical outcomes are same in terms of complication and recovery.
Follow-up schedule
Patients are followed up in the outpatient department at four weeks, three months, six months, and twelve months after the operation, and every six months thereafter. On each visit, history was reviewed and physical examination was done. A complete blood count (CBC) and serum chemistry were evaluated also. An esophago-gastro-duodenoscopy (EGD) was performed at three months after the operation and yearly thereafter. Abdominal computed tomography (ACT) was evaluated annually.
- Assessment of QOL The European EORTC QLQ-C30 (version 3.0) questionnaire is a 30-item cancer-specific integrated system for assessing the health-related QOL of cancer patients. The questionnaire incorporates five scales of function (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea and vomiting), a global health and QOL scale, and single items for the assessment of additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss, sleep disturbance, constipation and diarrhea), as well as the perceived financial impact of the disease and treatment. All items were scored on four-point Likert scales, with the exception of two items in the global health QOL scale, which used modified seven-point linear analog scales. The EORTC QLQ-STO22 with a 22-item stomach cancer-specific questionnaire was also used. It incorporates five hypothesized scales-(dysphasia, eating restrictions, pain, reflux and anxiety) and four single items (having a dry mouth, body image, taste, and hair loss) covering disease and treatment-related symptoms and specific emotional consequences of gastric cancer.12 All instruments of the questionnaire were administered preoperatively and postoperatively at seven days, 30 days, 90 days and yearly. Those time points were chosen at usual follow-up schedule for every gastrectomized patients in our institute, to maximize compliance for the questionnaire, and to compare other parameters at the same time.
- Statistical analyses The EORTC QLQ-C30 symptom subscale and the EORTC QLQ-STO22 subscale scores are reported using a scale from 0 to 100. Statistical analyses of the QOL outcomes evaluated the differences between the LADG and the ODG groups with respect to the overall changes from the preoperative scores (baseline) to those obtained at follow-up. To adjust for possible baseline differences, we included the baseline values in the model. All comparisons between groups were based on 'intent-to-treat' analyses in which patients were analyzed according to their assigned treatment group. Categorical variables were compared using the χ2 test, and continuous variables were analyzed using the Student's t-test. Analysis of Covariance (ANCOVA) with repeated measures was used to compare the two groups of patients with respect to overall changes in their short term quality of life after the surgery. The SAS (SAS Institute Inc., Cary, NC, USA) program called 'PROC GLM' was used.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Gyeonggi-do
-
Goyang, Gyeonggi-do, Korea, Republikken, 410-769
- National Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of stomach
- Age: 18-80 years
- Performance status: ECOG 0-1
- Informed consent should be signed
- EGD finding of early gastric cancer
- EUS finding of mucosa and submucosa cancer
- The location of the tumor should be antrum, angle, lower body in greater curvature in UGIS
- No evidence of distant metastasis in abdomen CT, and chest PA
- Regional lymph node metastasis confined to perigastric node (N1) in CT and EUS
Exclusion Criteria:
- Any comorbidity obviating major surgery
- Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy
- Previous upper abdominal operation
- Indication of EMR: well or moderately differentiated adenocarcinoma, less than 2 cm in EGC type I and IIa, less than 1cm in EGC type IIb and IIc, no ulceration
- Complicated case needed to get emergency operation
- Any accompanying surgical condition needed to be performed in same time
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Laparoscopy assisted distal gastrectomy
Laparoscopy assisted distal gastrectomy with D2 lymph node dissection.Surgery will be done in similar operative extent with control open distal gastrectomy.
Omentectomy will be omitted.
|
under general endotracheal anesthesia, Five laparoscopic ports are made.
Lymph node dissection and ligations of vessels are done in laparoscopic field.
A 5-6cm small incision is made transversely in RUQ of the abdomen.
Through the incisional window, stomach is taken out and resected.
A Billroth I gastroduodenostomy using EEA stapler and GIA is performed.
Abdomen is closed after hemostasis.
Andre navn:
|
Aktiv komparator: Open Distal Gastrectomy
Conventional standard D2 open distal gastrectomy without omentectomy.
|
Open distal gastrectomy is performed under general endotracheal anesthesia.
A long midline incision is made.
omentectomy is skipped and D2 lymph node dissection is performed.
Anastomosis is done in same manner as LADG.
Abdomen is closed after hemostasis
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
5 year disease free survival
Tidsramme: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
|
Laparoscopy assisted distal gastrectomy could be accepted as a oncologically safe and effective treatment if 5 year disease free survival is not inferior compared to open distal gastrectomy.
Any recurrence event will be followed up through regular physical and history examinations, imaging by abdominal computed tomography,esophagogastroduodenoscopy and tumor marker like CEA, CA 19-9,and CA 72-4
|
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Quality of life measured by EORTC QLQ
Tidsramme: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
|
EORTC C-30 & Sto-22 engines were measured by self administered questionnaires to compare quality of life between two surgery.
Short term evaluation at 3 months, and long term evaluation after 5 years will be done.
|
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
|
Surgical complications
Tidsramme: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months
|
Any surgical complications during and after operation will be compared.
Long term complications will be monitored also.
|
1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months
|
Postoperative surgical outcome
Tidsramme: within 1 week daily
|
day of starting bowel movement, day of defevescence, hospital stay, white blood cell counts, C reactive protein, amount of transfusion
|
within 1 week daily
|
Overall survival
Tidsramme: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
|
Overall survival regardless of cause of death
|
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Young-Woo Kim, M.D., Ph.D., National Cancer Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kim YW, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, Bae JM. Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Ann Surg. 2008 Nov;248(5):721-7. doi: 10.1097/SLA.0b013e318185e62e.
- Kim YW, Yoon HM, Yun YH, Nam BH, Eom BW, Baik YH, Lee SE, Lee Y, Kim YA, Park JY, Ryu KW. Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301). Surg Endosc. 2013 Nov;27(11):4267-76. doi: 10.1007/s00464-013-3037-x. Epub 2013 Jun 21.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- _NCCCTS-052
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. .
Kliniske studier på Magekreft
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)FullførtRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertical Sleeve Gastrectomy | Magebånd | Bypass, GastricForente stater
-
Medtronic - MITGFullført
-
North Dakota State UniversityNational Institutes of Health (NIH)FullførtRoux en Y Gastric Bypass kirurgiForente stater
-
DuomedAktiv, ikke rekrutterendeOvervekt | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgia
-
Olympus Corporation of the AmericasUnity Health TorontoFullført
-
Wageningen UniversityRijnstate HospitalUkjentRoux-en-Y Gastric BypassNederland
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaFullførtRoux en Y Gastric BypassForente stater
-
Rijnstate HospitalFullførtRoux-en-Y Gastric Bypass | Magetømming | Bariatrisk kirurgiNederland
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaFullførtSleeve Gastrectomy | Roux en Y Gastric BypassForente stater
-
Rijnstate HospitalFullførtBariatrisk kirurgi | Jern absorpsjon | Roux- en -y Gastric BypassNederland
Kliniske studier på laparoscopy assisted distal gastrectomy
-
Fujian Medical UniversityHar ikke rekruttert ennåMagekreft | Robotisk gastrektomiKina
-
Southwest Hospital, ChinaThe First Affiliated Hospital of Nanchang University; Sun Yat-sen University og andre samarbeidspartnereUkjent
-
University of BolognaFullførtSiewert Type II Adenocarcinoma of Esophagogastric JunctionItalia
-
Fudan UniversityRekruttering
-
Yonsei UniversityFullført
-
Samsung Medical CenterUkjent
-
Zagazig UniversityFullførtKandidat for fedmekirurgiEgypt
-
National Cancer Center, KoreaSamsung Medical Center; Seoul National University Hospital; Seoul National... og andre samarbeidspartnereUkjentMagekreftKorea, Republikken
-
Seoul National University Bundang HospitalRekrutteringMagekreft | Gastrisk adenokarsinomKorea, Republikken