Gastric CancerNCT04384757
Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer
A study testing Distal gastrectomy in people with 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 is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage 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?
- Distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteVietnam
- Study dates
- 29 Jul 2020to 30 Jun 2028
- 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 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial
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
Read the detailed description
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.
- Conditions
- Gastric Cancer
- Being tested
- Distal gastrectomy
- Keywords
- gastric cancer, laparoscopic gastrectomy, T4a stage
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal gastrectomyProcedure or surgery
Distal gastrectomy and standard D2 lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Open distal gastrectomy | Active comparator | 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 II method was used for gastric reconstruction for most cases Receives: Procedure: Distal gastrectomy |
| Laparoscopic distal gastrectomy | Experimental | 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 II method was used for gastric reconstruction for most cases Receives: Procedure: Distal 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
hospital stay
The number of days between surgery and discharge
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start29 Jul 2020
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VoDuy Long, University Medical Center Ho Chi Minh City (UMC)
- Investigators
- Long D. Vo, PhD, MD, Principal investigator, University Medical Center, 215 Hong Bang street, Dist. 5, HCM city, VN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384757
- Sponsor's protocol ID
- UMC-UPPERGI-01
- Status last verified
- Jun 2025
- First submitted
- 8 May 2020
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Waiting for the results of this study
Publications
Dat TQ, Thong DQ, Nguyen DT, Hai NV, Phuoc TD, Anh NVT, Bac NH, Long VD. Laparoscopic vs Open Distal Gastrectomy With D2 Lymphadenectomy for Clinical T4a Gastric Cancer: The UMC-UPPERGI-01 Randomized Clinical Trial. JAMA Surg. 2026 Jan 1;161(1):9-18. doi: 10.1001/jamasurg.2025.4929.
PubMed 41222957Dat TQ, Thong DQ, Nguyen DT, Hai NV, Vuong NL, Bac NH, Long VD. Laparoscopic versus open distal gastrectomy with d2 lymphadenectomy in treatment of locally T4A gastric cancer: the protocol of a randomized controlled trial. BMC Surg. 2025 May 2;25(1):193. doi: 10.1186/s12893-025-02933-6.
PubMed 40316937
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04384757
- Acronym / sponsor ID
- UMC-UPPERGI-01
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, laparoscopic gastrectomy, T4a stage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 12 May 2020 (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 is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open distal gastrectomy | Active comparator | Procedure: Distal gastrectomyAn 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 II method was used for gastric reconstruction for most cases |
| Laparoscopic distal gastrectomy | Experimental | Procedure: 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 II method was used for gastric reconstruction for most cases |
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 located at the middle or lower third of the stomach
- Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0
- ASA score: ≤ 3
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Distal gastrectomyDistal gastrectomy and standard D2 lymphadenectomy | Procedure or surgery | Laparoscopic distal gastrectomy, Open distal 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
hospital stay
Time frame: 30 days after surgery
operative time
Time frame: intraoperative
Resected lymph nodes
Time frame: intraoperative
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 15 Jun 2025.
- Derived from this study: PubMed 41222957Dat TQ, Thong DQ, Nguyen DT, Hai NV, Phuoc TD, Anh NVT, Bac NH, Long VD. Laparoscopic vs Open Distal Gastrectomy With D2 Lymphadenectomy for Clinical T4a Gastric Cancer: The UMC-UPPERGI-01 Randomized Clinical Trial. JAMA Surg. 2026 Jan 1;161(1):9-18. doi: 10.1001/jamasurg.2025.4929.
- Derived from this study: PubMed 40316937Dat TQ, Thong DQ, Nguyen DT, Hai NV, Vuong NL, Bac NH, Long VD. Laparoscopic versus open distal gastrectomy with d2 lymphadenectomy in treatment of locally T4A gastric cancer: the protocol of a randomized controlled trial. BMC Surg. 2025 May 2;25(1):193. doi: 10.1186/s12893-025-02933-6.
- Individual participant dataSharing planned: Undecided. Waiting for the results of this study
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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, PhD, MD principal investigator
University Medical Center, 215 Hong Bang street, Dist. 5, HCM city, VN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal gastrectomy in people with 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. 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?
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?
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?
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 NCT04384757, which also lists 2 linked publications.
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 15 Jun 2025.