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.
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
- Recruiting
Dong Nai General Hospital
Bien Hoa, Dong Nai, 810000
Nguyen Kim Kien, 0938770667, bsnguyenkimkien@gmail.com
- Not yet recruiting
108 Military Central Hospital
Hà Nội, 100000
Pham Van Hiep, Ph.D, drphamvanhiep108@gmail.com
- 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.
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 group | Role | What they receive |
|---|---|---|
| Laparoscopic total gastrectomy | Experimental | 5 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 gastrectomy | Active comparator | An 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.
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
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)
operative morbidity
The rate of postoperative bleeding and the rate of postoperative leakage
Measured: 30 days after surgery
operative mortality
The rate of postoperative dead
Measured: 30 days after surgery
operative time
The duration of a surgical procedure in minutes.
Measured: intraoperative
Resected lymph nodes
The number of lymph nodes harvested after surgery
Measured: intraoperative
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.
- First posted11 Jan 2024
- Study start2 Aug 2024
- Primary completion2 Aug 2032 (estimated)
- Study completion2 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer: a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06202105
- Acronym / sponsor ID
- LOTA / LOTA
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 2 Aug 2032 (estimated)
- Study completion
- 2 Aug 2032 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic total gastrectomy | Experimental | Procedure: Laparoscopic gastrectomy5 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 |
| Open total gastrectomy | Active comparator | Procedure: Laparoscopic gastrectomyAn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic gastrectomyGastrectomy with laparoscopic approach | Procedure or surgery | Laparoscopic total gastrectomy, Open total gastrectomy |
Primary outcome
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
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.
5 secondary outcomes
operative morbidity
Time frame: 30 days after surgery
operative mortality
Time frame: 30 days after surgery
operative time
Time frame: intraoperative
Resected lymph nodes
Time frame: intraoperative
hospital stay
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
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?
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.