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NCT Number: NCT06202105

Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer

Evidence of implementation of laparoscopic total gastrectomy (LTG) for locally advanced gastric cancer (GC) remains inadequate. This study aimed to compare short- and mid-term outcomes of LTG versus open total gastrectomy (OTG) for cT2-4a GC.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong Nai General Hospital, Bien Hoa, Dong Nai, Vietnam

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About this study

Gastric cancer (GC) is a significant public health issue worldwide. Surgical resection and lymphadenectomy is the first option for curative treatment of this disease. For tumors located in the middle and/or upper third of the stomach, open total gastrectomy (OTG) has long been the standard surgery.

While the advantage of laparoscopic distal gastrectomy over open distal gastrectomy for not only early gastric cancer (EGC) but also locally advanced gastric cancer (AGC) had been proven, the use of laparoscopic total gastrectomy (LTG) for GC, particularly for AGC, has not been widely accepted due to technical challenges with lymphadenectomy at the distal pancreas and the splenic hilum as well as the complexity of the esophago-jejunal reconstruction. Recently, there has been advancement in laparoscopic techniques and improved surgical experience, a standard procedure of LTG has been established, leading to increase utilization of LTG, especially for EGC. Two large RCTs, KLASS-03 in Korea and CLASS-02 in China, provided good evidence for the advantages of LTG for EGC. However, for AGC, some prior studies have demonstrated the safety of LTG compared to OTG but lacked significant data for survival. Until now, there have been no completed RCTs to determine the short- and long-term outcomes of LTG for AGC.

In the research center, LTG has been accepted as a standard procedure for EGC since 2008 and for AGC since 2013. In Vietnam and other low-to-middle-income countries, most GC was diagnosed in an advanced stage. It is needed to have evidence of the feasibility, safety, and oncological results of LTG for locally advanced GC. Investigators performed this study to compare the technical feasibility, short- and long-term outcomes of LTG versus OTG for stage T2-4a GC.

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 required total gastrectomy for radical treatment
  • Preoperative cancer stage (CT scan stage): cT2-4aNanyM0
  • 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
  • Bulky lymph node andd/or Para-aortic lymph node metastasis
  • Combined esophagectomy due to invading to the esophagus
  • Pregnant patient

Treatment and study plan

Laparoscopic Gastrectomy

Procedure

Gastrectomy with laparoscopic approach

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. operative time

    Time frame: intraoperative

    The duration of a surgical procedure in minutes.

  4. Resected lymph nodes

    Time frame: intraoperative

    The number of lymph nodes harvested after surgery

  5. hospital stay

    Time frame: 30 days after surgery

    The number of days between surgery and discharge

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer: a Prospective Randomized Control Trial

Acronym: LOTA

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Jan 11, 2024
Registry last updated
Jan 1, 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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