ABSTRACT
PURPOSE: Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer. MATERIALS AND METHODS: Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopy-assisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation. DISCUSSION: Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer.Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).
Subject(s)
Humans , Arm , Disease-Free Survival , Endoscopy , Gastrectomy , Informed Consent , Laparoscopy , Length of Stay , Lymph Node Excision , Lymph Nodes , Postoperative Complications , Prospective Studies , Sample Size , Stomach NeoplasmsABSTRACT
BACKGROUND: We evaluated the efficacy and toxicity of docetaxel plus cisplatin combination as first-line chemotherapy for advanced gastric cancer. METHODS: Patients with metastatic or recurrent gastric adenocarcinoma, performance score Subject(s)
Humans
, Adenocarcinoma
, Cisplatin
, Drug Therapy
, Drug Therapy, Combination
, Febrile Neutropenia
, Neutropenia
, Stomach Neoplasms
ABSTRACT
While the results of abdominal aortic surgery has been improving, it still remained as an operation which can be accompanied by serious complications leading to operative mortality. During the period of 4 years and 8 months, we performed 86 abdominal aortic operations for the patients with abdominal aortic aneurysm(AAA, n=44), aortoiliac occlusive disease(AIOD, n=40), and traumatic aortic injury (n=2). To review the early postoperative (<30 days) complications and mortality, 84 patients with AAA and AIOD were included in this study. Operation procedures for the 84 patients were implantation of 73 bifurcated and 9 tube aortic grafts, and 1 aortic thromboendarterectomy, and 1 transaortic suture closure of aneurysmal neck for the patient with saccular aneurysm at the suprarenal aortic segment. The early postoperative complications were categorized as local vascular, local non-vascular, remote vascular, and systemic complications from beginning of this study. Retrospective review of complication data was performed in 4 groups of patients: Emergent AAA group (n=18), Elective AAA group (n=26), Emergent AIOD group (n=6), and Elective AIOD group (n=34). The frequencies of early postoperative systemic complications were 37.5% and 10% after emergent and elective aortic surgery, respectively. The frequency of major systemic complications following AAA repair was respiratory (5/18, 27.8%), renal (4/18, 22.2%) complications in emergent AAA group and cardiac (2/26, 7.6%), respiratory (1/26, 3.8%), and renal (1/26, 3.8%) compliations in elctive AAA group. The frequency of major systemic complication following AIOD surgery were renal (2/6, 33.3%), cardiac complication (1/6, 16.7%) in emergent AIOD group and respiratoy (3/34, 8.8%) complication in elective AIOD group. Three (3.6%) serious cardiac complications resulting in 1 mortality developed after all abdominal aortic operations. Four operative mortality (overall mortality rate: 4.8%) occurred in in emergent AAA group (2/18, 11.1%) and in emergent AIOD group (2/6, 33.3%). There occurred no operative mortality in the elective surgery group.