Gastric Cancer
Conditions
Brief summary
Evidence of implementation of laparoscopic total gastrectomy (LTG) for locally advanced gastric cancer (GC) remains inadequate. This study aimed to compare short- and mid-term outcomes of LTG versus open total gastrectomy (OTG) for cT2-4a GC.
Detailed description
Gastric cancer (GC) is a significant public health issue worldwide. Surgical resection and lymphadenectomy is the first option for curative treatment of this disease. For tumors located in the middle and/or upper third of the stomach, open total gastrectomy (OTG) has long been the standard surgery. While the advantage of laparoscopic distal gastrectomy over open distal gastrectomy for not only early gastric cancer (EGC) but also locally advanced gastric cancer (AGC) had been proven, the use of laparoscopic total gastrectomy (LTG) for GC, particularly for AGC, has not been widely accepted due to technical challenges with lymphadenectomy at the distal pancreas and the splenic hilum as well as the complexity of the esophago-jejunal reconstruction. Recently, there has been advancement in laparoscopic techniques and improved surgical experience, a standard procedure of LTG has been established, leading to increase utilization of LTG, especially for EGC. Two large RCTs, KLASS-03 in Korea and CLASS-02 in China, provided good evidence for the advantages of LTG for EGC. However, for AGC, some prior studies have demonstrated the safety of LTG compared to OTG but lacked significant data for survival. Until now, there have been no completed RCTs to determine the short- and long-term outcomes of LTG for AGC. In the research center, LTG has been accepted as a standard procedure for EGC since 2008 and for AGC since 2013. In Vietnam and other low-to-middle-income countries, most GC was diagnosed in an advanced stage. It is needed to have evidence of the feasibility, safety, and oncological results of LTG for locally advanced GC. Investigators performed this study to compare the technical feasibility, short- and long-term outcomes of LTG versus OTG for stage T2-4a GC.
Interventions
PROCEDURELaparoscopic gastrectomy
Gastrectomy with laparoscopic approach
Sponsors
University Medical Center Ho Chi Minh City (UMC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma * Age: 18 - 80 year old * Tumor required total gastrectomy for radical treatment * Preoperative cancer stage (CT scan stage): cT2-4aNanyM0 * ASA score: ≤ 3 * Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
Exclusion criteria
* Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer * Bulky lymph node andd/or Para-aortic lymph node metastasis * Combined esophagectomy due to invading to the esophagus * Pregnant patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 year overall survival by Kaplan Mayer | 3 year after surgery | The percentage of people in this study who are alive three years after surgery |
| 3 year relapse-free survival by Kaplan Mayer | 3 year after surgery | The percentage of people in this study who are alive without recurrence three years after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operative time | intraoperative | The duration of a surgical procedure in minutes. |
| operative morbidity | 30 days after surgery | The rate of postoperative bleeding and the rate of postoperative leakage |
| hospital stay | 30 days after surgery | The number of days between surgery and discharge |
| Resected lymph nodes | intraoperative | The number of lymph nodes harvested after surgery |
| operative mortality | 30 days after surgery | The rate of postoperative dead |
Countries
Vietnam
Outcome results
None listed