Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

Last updated: June 13, 2025
Sponsor: University Medical Center Ho Chi Minh City (UMC)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

Distal gastrectomy

Clinical Study ID

NCT04384757
UMC-UPPERGI-01
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 thepatients or patrons, if patient is not available)

Exclusion

Exclusion Criteria:

  • Concurrent cancer or patient who was treated due to other cancer before the patientwas diagnosed gastric cancer

  • Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy

  • Pregnant patient

  • Combined resection

  • Total gastrectomy

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Distal gastrectomy
Phase:
Study Start date:
July 29, 2020
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • University Medical Center

    Ho Chi Minh City, Ho Chi Minh 700000
    Vietnam

    Site Not Available

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