Gastric CancerNCT05493358
Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer
An observational study of Gastric Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial 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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Laparoscopic distal gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 472 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2013to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with surgical T4a (sT4a) gastric adenocarcinoma at the lower or middle third of the stomach who underwent ODG or LDG plus lymphadenectomy between January 2013 and December 2020 at the Gastro-intestinal Surgical Department of the University Medical Center at Ho Chi Minh City, Vietnam
Who may be able to join
- patients with histologically confirmed adenocarcinoma of the stomach, surgical staging of sT4aN0-3M0 according to the 7th edition of the American Joint Committee on Cancer/Union Internationale Contre le Cancer (AJCC/UICC) staging system
Who cannot join
- intraoperatively detected bulky lymph nodes
- inadequate lymphadenectomy (D0, D1, D1+)
- macroscopic residual tumor (R2)
- an American Society of Anaesthesiology (ASA) score of > IV
- concurrent cancer or history of previous other cancers
- previous gastrectomy
- neoadjuvant chemotherapy
- complications such as bleeding or perforation required emergency gastrectomy.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: a Propensity Score-matched Cohort Study
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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.
Read the detailed description
Gastric cancer 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 worldwide now.
Laparoscopic gastrectomy for locally advanced gastric cancer AGC have commonly used 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 for T4a stage.
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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.
- Conditions
- Gastric Cancer
- Being tested
- Laparoscopic distal 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 distal gastrectomyProcedure or surgery
Distal gastrectomy and standard D2 lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Open distal gastrectomy | An incision of 15~20 cm length is made in the abdominal midline . Standard distal gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, proper hepatic artery) . As a general rule, Billroth I, Billroth II or Roux en Y method was used for gastric reconstruction. | |
| Laparoscopic distal gastrectomy | 5 trocar 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 the right gastroepiploic and the inferior pyloric artery were vascularized and cut at their origin from the gastroduodenal artery, just above the pancreatic head, 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 prepared and separately divided and then the left gastric artery was vascularized to remove group 7.
The dissection was continued upward along the proximal branches of splenic vessels to remove group 11p and along the lesser curvature to remove group 1,3.
As a general rule, Billroth I, Billroth II or Roux en Y method was used for gastric reconstruction. Receives: Procedure: Laparoscopic distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year overall survival by Kaplan Mayer
The percentage of people in this study who are alive five years after surgery.
Measured: 5 year after surgery
5 year disease-free survival by Kaplan Mayer
The percentage of people in this study who are alive without recurrence/metastasis five years after surgery.
Measured: 5 year after surgery
Secondary outcomes (11)
1 year overall survival by Kaplan Mayer
The percentage of people in this study who are alive one years after surgery.
Measured: 1 year after surgery
3 year overall survival by Kaplan Mayer
The percentage of people in this study who are alive one years after surgery.
Measured: 3 year after surgery
1 year disease-free survival by Kaplan Mayer
The percentage of people in this study who are alive without recurrence/metastasis one years after surgery.
Measured: 1 year after surgery
3 year disease-free survival by Kaplan Mayer
The percentage of people in this study who are alive without recurrence/metastasis one years after surgery.
Measured: 3 year after surgery
operative morbidity
The overall rate of postoperative complications
Measured: 30 days after surgery
operative time
The duration of a surgical procedure in minutes.
Measured: intraoperative
operative blood loss
The amount of blood lost during procedure
Measured: intraoperative
time to flatus
Number of days from date of surgery until date of flatus
Measured: 30 days after surgery or until mortality ]
Postoperative hospital length of stay
Number of days from date of surgery until date of discharge or mortality
Measured: 30 days after surgery or until mortality
The percentage of complications with Clavien-Dindo
The percentage of complication grade by Clavien-Dindo classification
Measured: 30 days after surgery
The percentage of pattern of recurrence/metastasis
The percentage of pattern of recurrence/metastasis during follow up period
Measured: 5 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Jan 2013
- Primary completion31 Dec 2020
- Study completion30 Jun 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Long D. Vo, MD PhD., Principal investigator, University Medical Center HCMC, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493358
- Sponsor's protocol ID
- 71/GCN-HĐĐĐ
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: a Propensity Score-matched Cohort Study
- ClinicalTrials.gov ID
- NCT05493358
- Acronym / sponsor ID
- 71/GCN-HĐĐĐ
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Aug 2022 (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.
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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.
Detailed description
Gastric cancer 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 worldwide now.
Laparoscopic gastrectomy for locally advanced gastric cancer AGC have commonly used 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 for T4a stage.
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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open distal gastrectomy | – | –An incision of 15~20 cm length is made in the abdominal midline . Standard distal gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, proper hepatic artery) . As a general rule, Billroth I, Billroth II or Roux en Y method was used for gastric reconstruction. |
| Laparoscopic distal gastrectomy | – | Procedure: Laparoscopic distal gastrectomy5 trocar 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 the right gastroepiploic and the inferior pyloric artery were vascularized and cut at their origin from the gastroduodenal artery, just above the pancreatic head, 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 prepared and separately divided and then the left gastric artery was vascularized to remove group 7. The dissection was continued upward along the proximal branches of splenic vessels to remove group 11p and along the lesser curvature to remove group 1,3. As a general rule, Billroth I, Billroth II or Roux en Y method was used for gastric reconstruction. |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with surgical T4a (sT4a) gastric adenocarcinoma at the lower or middle third of the stomach who underwent ODG or LDG plus lymphadenectomy between January 2013 and December 2020 at the Gastro-intestinal Surgical Department of the University Medical Center at Ho Chi Minh City, Vietnam
Key inclusion criteria (1 listed)
- patients with histologically confirmed adenocarcinoma of the stomach, surgical staging of sT4aN0-3M0 according to the 7th edition of the American Joint Committee on Cancer/Union Internationale Contre le Cancer (AJCC/UICC) staging system
Key exclusion criteria (8 listed)
- intraoperatively detected bulky lymph nodes
- inadequate lymphadenectomy (D0, D1, D1+)
- macroscopic residual tumor (R2)
- an American Society of Anaesthesiology (ASA) score of > IV
- concurrent cancer or history of previous other cancers
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 distal gastrectomyDistal gastrectomy and standard D2 lymphadenectomy | Procedure or surgery | Laparoscopic distal gastrectomy |
Primary outcome
5 year overall survival by Kaplan Mayer
Time frame: 5 year after surgery
The percentage of people in this study who are alive five years after surgery.
5 year disease-free survival by Kaplan Mayer
Time frame: 5 year after surgery
The percentage of people in this study who are alive without recurrence/metastasis five years after surgery.
11 secondary outcomes
1 year overall survival by Kaplan Mayer
Time frame: 1 year after surgery
3 year overall survival by Kaplan Mayer
Time frame: 3 year after surgery
1 year disease-free survival by Kaplan Mayer
Time frame: 1 year after surgery
3 year disease-free survival by Kaplan Mayer
Time frame: 3 year after surgery
operative morbidity
Time frame: 30 days after surgery
operative time
Time frame: intraoperative
operative blood loss
Time frame: intraoperative
time to flatus
Time frame: 30 days after surgery or until mortality ]
Postoperative hospital length of stay
Time frame: 30 days after surgery or until mortality
The percentage of complications with Clavien-Dindo
Time frame: 30 days after surgery
The percentage of pattern of recurrence/metastasis
Time frame: 5 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Long D. Vo, MD PhD. principal investigator
University Medical Center HCMC, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year overall survival by Kaplan Mayer (time frame: 5 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 6 May 2023.