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Gastric CancerLOTANCT06202105

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

A study testing Laparoscopic gastrectomy in people with Gastric Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 3 sites in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastric Cancer
What is being tested?
Laparoscopic gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
3 sitesVietnam
Study dates
2 Aug 2024to 2 Aug 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam3 sites, 3 recruiting

  • Dong Nai General Hospital

    Bien Hoa, Dong Nai, 810000

    Nguyen Kim Kien, 0938770667, bsnguyenkimkien@gmail.com

    Recruiting

  • 108 Military Central Hospital

    Hà Nội, 100000

    Pham Van Hiep, Ph.D, drphamvanhiep108@gmail.com

    Not yet recruiting

  • University Medical Center Ho Chi Minh City

    Ho Chi Minh City, 700000

    Long D. Vo, MD., +84918133915, long.vd@umc.edu.vn

    L D.

    Recruiting

Other trials in Vietnam

About this study

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

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.

Read the detailed description

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.

Conditions
Gastric Cancer
Being tested
Laparoscopic gastrectomy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic gastrectomyProcedure or surgery

    Gastrectomy with laparoscopic approach

Study groups in NCT06202105
Study groupRoleWhat they receive
Laparoscopic total gastrectomyExperimental5 trocars were used. The gastrocolic ligament was divided along the border of the transverse colon. ligating the left gastroepiploic vessels to remove group 4sb. The right gastroepiploic vein was divided and right gastroepiploic and inferior pyloric artery were transected at their origin from the gastroduodenal artery to dissect group 6. The dissection was continued along the hepatoduodenal ligament to removed group 5 and group 12a and along the common hepatic artery to remove group 8a and along the celiac axis to remove group 9. The left gastric vein was divided and then the left gastric artery was vascularized to remove group 7. The dissection was continued upward along the splenic artery and its branches to remove group 11p,d and/or along the splenic hilum to remove group 10. The dissection was then conducted the right and left of the esophago-gastric junction to remove group 1,2. As a general rule, Roux en Y method was used for esophagoo-jejunal reconstruction for all cases
Receives: Procedure: Laparoscopic gastrectomy
Open total gastrectomyActive comparatorAn incision of 15~20 cm length is made in the abdominal midline . Standard total gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, along splenic artery, proper hepatic artery, and/or the splenic hilum) . Roux-en Y esophagojejunal anastomosis is performed for reconstruction.
Receives: Procedure: Laparoscopic gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3 year overall survival by Kaplan Mayer

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

    Measured: 3 year after surgery

  2. 3 year relapse-free survival by Kaplan Mayer

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

    Measured: 3 year after surgery

Secondary outcomes (5)

  1. operative morbidity

    The rate of postoperative bleeding and the rate of postoperative leakage

    Measured: 30 days after surgery

  2. operative mortality

    The rate of postoperative dead

    Measured: 30 days after surgery

  3. operative time

    The duration of a surgical procedure in minutes.

    Measured: intraoperative

  4. Resected lymph nodes

    The number of lymph nodes harvested after surgery

    Measured: intraoperative

  5. hospital stay

    The number of days between surgery and discharge

    Measured: 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start2 Aug 2024
  3. Primary completion2 Aug 2032 (estimated)
  4. Study completion2 Aug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06202105
Sponsor's protocol ID
LOTA
Acronym
LOTA
Status last verified
Dec 2024
First submitted
30 Dec 2023
Last updated
1 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic gastrectomy in people with Gastric Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 3 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3 year overall survival by Kaplan Mayer (time frame: 3 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06202105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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