Clinical trial NCT05493358: Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer
Official title: Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: a Propensity Score-matched Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 472
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with surgical T4a (sT4a) gastric adenocarcinoma at the lower or middle third of the stomach who underwent ODG or LDG plus lymphadenectomy between January 2013 and December 2020 at the Gastro-intestinal Surgical Department of the University Medical Center at Ho Chi Minh City, Vietnam

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 5 year overall survival by Kaplan Mayer
timeFrame: 5 year after surgery
measure: 5 year disease-free survival by Kaplan Mayer
timeFrame: 5 year after surgery
Secondary outcomes:
measure: 1 year overall survival by Kaplan Mayer
timeFrame: 1 year after surgery
measure: 3 year overall survival by Kaplan Mayer
timeFrame: 3 year after surgery
measure: 1 year disease-free survival by Kaplan Mayer
timeFrame: 1 year after surgery
measure: 3 year disease-free survival by Kaplan Mayer
timeFrame: 3 year after surgery
measure: operative morbidity
timeFrame: 30 days after surgery
measure: operative time
timeFrame: intraoperative
measure: operative blood loss
timeFrame: intraoperative
measure: time to flatus
timeFrame: 30 days after surgery or until mortality ]
measure: Postoperative hospital length of stay
timeFrame: 30 days after surgery or until mortality
measure: The percentage of complications with Clavien-Dindo
timeFrame: 30 days after surgery
measure: The percentage of pattern of recurrence/metastasis
timeFrame: 5 year after surgery
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
affiliation: University Medical Center HCMC, Vietnam
name: Long D. Vo, MD PhD.
role: PRINCIPAL_INVESTIGATOR
References: