Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: a Propensity Score-matched Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 472
- Locations
- 1
- Primary Endpoint
- 5 year overall survival by Kaplan Mayer
Study Overview
Brief Summary
There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.
Detailed Description
Gastric cancer is one of the most common cancers in Vietnam . Despite recent advances in multimodality treatment and targeted therapy, surgery remains the first option of treament for this disease. For resectable gastric cancer, complete removal of macroscopic and microscopic lesions and/or combined resections and also regional or extended lymphadenectomy should represent worldwide now.
Laparoscopic gastrectomy for locally advanced gastric cancer AGC have commonly used for treatment of AGC, especially in Japan, Korea and China. However, the real role of laparoscop for treament of (AGC) is still controversial in term of technical feasibility, safety and oncologic aspect for T4a stage.
Paragastric inflammatory strands may occur in T4a tumor so that laparoscopic technique is difficult to radically perform. Peritoneal seeding of malignant cells, intra- and postoperative complications, trocarts metastasis may risk during procedures. Despite, some studies have demonstrated the safety and the short-term benefits of LG for T4a gastric cancer, the number of these studies and sample sizes have been still inadequate to give good evidence for applying it. and long-term oncologic outcomes There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 15 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with histologically confirmed adenocarcinoma of the stomach, surgical staging of sT4aN0-3M0 according to the 7th edition of the American Joint Committee on Cancer/Union Internationale Contre le Cancer (AJCC/UICC) staging system
Exclusion Criteria
- •intraoperatively detected bulky lymph nodes
- •inadequate lymphadenectomy (D0, D1, D1+)
- •macroscopic residual tumor (R2)
- •an American Society of Anaesthesiology (ASA) score of > IV
- •concurrent cancer or history of previous other cancers
- •previous gastrectomy
- •neoadjuvant chemotherapy
- •complications such as bleeding or perforation required emergency gastrectomy.
Outcomes
Primary Outcomes
5 year overall survival by Kaplan Mayer
Time Frame: 5 year after surgery
The percentage of people in this study who are alive five years after surgery.
5 year disease-free survival by Kaplan Mayer
Time Frame: 5 year after surgery
The percentage of people in this study who are alive without recurrence/metastasis five years after surgery.
Secondary Outcomes
- operative blood loss(intraoperative)
- operative time(intraoperative)
- 1 year overall survival by Kaplan Mayer(1 year after surgery)
- 3 year overall survival by Kaplan Mayer(3 year after surgery)
- 1 year disease-free survival by Kaplan Mayer(1 year after surgery)
- 3 year disease-free survival by Kaplan Mayer(3 year after surgery)
- operative morbidity(30 days after surgery)
- time to flatus(30 days after surgery or until mortality ])
- Postoperative hospital length of stay(30 days after surgery or until mortality)
- The percentage of complications with Clavien-Dindo(30 days after surgery)
- The percentage of pattern of recurrence/metastasis(5 year after surgery)