Clinical Study on Laparoscopic Gastrectomy for Early Gastric Cancer (COACT_0301) (NCC052)
|ClinicalTrials.gov Identifier: NCT00546468|
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : May 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Procedure: laparoscopy assisted distal gastrectomy Procedure: Open distal gastrectomy||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial of Laparoscopy-assisted Distal Gastrectomy (LADG) Versus Open Distal Gastrectomy (ODG) in Patients With Early Gastric Cancer (EGC)|
|Study Start Date :||June 2003|
|Primary Completion Date :||November 2005|
|Study Completion Date :||December 2010|
Experimental: 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.
Procedure: laparoscopy assisted distal gastrectomy
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.
Other Name: LADG
Active Comparator: Open Distal Gastrectomy
Conventional standard D2 open distal gastrectomy without omentectomy.
Procedure: Open distal gastrectomy
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
Other Name: ODG
- 5 year disease free survival [ Time Frame: 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
- Quality of life measured by EORTC QLQ [ Time Frame: 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.
- Surgical complications [ Time Frame: 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.
- Postoperative surgical outcome [ Time Frame: within 1 week daily ]day of starting bowel movement, day of defevescence, hospital stay, white blood cell counts, C reactive protein, amount of transfusion
- Overall survival [ Time Frame: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years ]Overall survival regardless of cause of death
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546468
|Korea, Republic of|
|National Cancer Center|
|Goyang, Gyeonggi-do, Korea, Republic of, 410-769|
|Principal Investigator:||Young-Woo Kim, M.D., Ph.D.||National Cancer Center|