Clinical trial NCT04384757: Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer
Official title: Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Keywords: gastric cancer
laparoscopic gastrectomy
T4a stage
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage

Detailed description: Gastric cancer poses a significant public health problem. It 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 in the world now. Since laparoscopic gastrectomy for early gastric cancer (EGC) was firstly reported in 1994 , this technique has become standard for treatment of EGC due to the many advantages of mininally invasive surgery and also in oncologic outcomes.

Laparoscopic gastrectomy for advanced gastric cancer AGC was first applied by Uyama in 2000, and then, many surgeons have used it 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.

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 is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage.

Eligibility criteria: Inclusion Criteria:

* Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
* Age: 18 - 80 year old
* Tumor located at the middle or lower third of the stomach
* Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0
* 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
* Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
* Pregnant patient
* Combined resection
* Total gastrectomy

Primary outcomes:
measure: 3 year overall survival by Kaplan Mayer
timeFrame: 3 year after surgery
measure: 3 year relapse-free survival by Kaplan Mayer
timeFrame: 3 year after surgery
Secondary outcomes:
measure: operative morbidity
timeFrame: 30 days after surgery
measure: operative mortality
timeFrame: 30 days after surgery
measure: hospital stay
timeFrame: 30 days after surgery
measure: operative time
timeFrame: intraoperative
measure: Resected lymph nodes
timeFrame: intraoperative
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center
state: Ho Chi Minh
Study officials:
affiliation: University Medical Center, 215 Hong Bang street, Dist. 5, HCM city, VN
name: Long D. Vo, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: