Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

Not Applicable

Active, not recruiting

• Conditions: Gastric Cancer

• Registration Number: NCT04384757
• Lead Sponsor: University Medical Center Ho Chi Minh City (UMC)

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.

Study Timeline

• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-12
• Study Start: 2020-07-29
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
operative mortality	30 days after surgery	The rate of postoperative dead
hospital stay	30 days after surgery	The number of days between surgery and discharge
operative morbidity	30 days after surgery	The rate of postoperative bleeding and the rate of postoperative leakage
operative time	intraoperative	The duration of a surgical procedure in minutes.
Resected lymph nodes	intraoperative	the number of lymph nodes harvested after surgery

Trial Locations

Locations (1)

University Medical Center; 🇻🇳 Ho Chi Minh City, Ho Chi Minh, Vietnam