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NCT Number: NCT04384757

Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distal gastrectomy

Procedure

Distal gastrectomy and standard D2 lymphadenectomy

Primary outcomes

  1. 3 year overall survival by Kaplan Mayer

    Time frame: 3 year after surgery

    The percentage of people in this study who are alive three years after surgery.

  2. 3 year relapse-free survival by Kaplan Mayer

    Time frame: 3 year after surgery

    The percentage of people in this study who are alive without recurrence three years after surgery.

Secondary outcomes

  1. operative morbidity

    Time frame: 30 days after surgery

    The rate of postoperative bleeding and the rate of postoperative leakage

  2. operative mortality

    Time frame: 30 days after surgery

    The rate of postoperative dead

  3. hospital stay

    Time frame: 30 days after surgery

    The number of days between surgery and discharge

  4. operative time

    Time frame: intraoperative

    The duration of a surgical procedure in minutes.

  5. Resected lymph nodes

    Time frame: intraoperative

    the number of lymph nodes harvested after surgery

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
May 12, 2020
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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