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Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: a Propensity Score-matched Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05493358
Enrollment
472
Registered
2022-08-09
Start date
2013-01-01
Completion date
2022-06-30
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

Distal gastrectomy and standard D2 lymphadenectomy

Sponsors

University Medical Center Ho Chi Minh City (UMC)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 90 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
5 year overall survival by Kaplan Mayer5 year after surgeryThe percentage of people in this study who are alive five years after surgery.
5 year disease-free survival by Kaplan Mayer5 year after surgeryThe percentage of people in this study who are alive without recurrence/metastasis five years after surgery.

Secondary

MeasureTime frameDescription
1 year disease-free survival by Kaplan Mayer1 year after surgeryThe percentage of people in this study who are alive without recurrence/metastasis one years after surgery.
3 year disease-free survival by Kaplan Mayer3 year after surgeryThe percentage of people in this study who are alive without recurrence/metastasis one years after surgery.
operative morbidity30 days after surgeryThe overall rate of postoperative complications
operative timeintraoperativeThe duration of a surgical procedure in minutes.
1 year overall survival by Kaplan Mayer1 year after surgeryThe percentage of people in this study who are alive one years after surgery.
time to flatus30 days after surgery or until mortality ]Number of days from date of surgery until date of flatus
Postoperative hospital length of stay30 days after surgery or until mortalityNumber of days from date of surgery until date of discharge or mortality
The percentage of complications with Clavien-Dindo30 days after surgeryThe percentage of complication grade by Clavien-Dindo classification
The percentage of pattern of recurrence/metastasis5 year after surgeryThe percentage of pattern of recurrence/metastasis during follow up period
operative blood lossintraoperativeThe amount of blood lost during procedure
3 year overall survival by Kaplan Mayer3 year after surgeryThe percentage of people in this study who are alive one years after surgery.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026