Gastric Cancer, Gastroesophageal Junction CancerNCT06791538
Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
A study testing Robotic Gastrectomy and Laparoscopic Gastrectomy in people with Gastric Cancer, Gastroesophageal Junction Cancer, run by Southwest Hospital, China at 2 sites in China.
Trial summary
This [Study Type: Clinical Trial] aims to [Primary Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer] in [Participant Population: patients with locally advanced gastric cancer, aged >18 years and <75 years]. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- Robotic Gastrectomy and Laparoscopic Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2025to 1 Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 75 years.
- Primary gastric lesion histologically confirmed as gastric adenocarcinoma (including papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, etc.) via endoscopic biopsy.
- Preoperative clinical staging as locally advanced gastric cancer (cT2-4a, N0-3, M0) according to the 8th edition of the AJCC TNM staging system.
- No distant metastasis on preoperative examination, and no direct invasion of the pancreas, spleen, or other adjacent organs.
- Preoperative ECOG performance status score of 0 or 1.
- Preoperative ASA (American Society of Anesthesiologists) physical status score of I-III.
- Consent to participate in the study and signing of the informed consent form.
Who cannot join
- Previous history of gastric malignancy surgery, including submucosal resection and/or endoscopic mucosal resection.
- History of upper abdominal surgery (excluding laparoscopic cholecystectomy).
- Preoperative imaging shows regional lymph nodes with confluent enlargement (maximum diameter ≥3cm).
- Patient underwent emergency surgery due to gastric tumor bleeding or perforation.
- History of other malignancies, or presence of other malignant tumors detected during preoperative examination.
- Patient has a history of malignant tumor, or other malignant tumors were found during preoperative examination
Show all 14Show fewer
- ASA (American Society of Anesthesiologists) score >3.
- Severe psychiatric disorders.
- History of unstable angina or myocardial infarction within the past 6 months.
- History of cerebral infarction or cerebral hemorrhage within the past 6 months.
- Severe pulmonary disease with FEV1 < 50%.
- Systemic corticosteroid therapy within 1 month prior to the study.
- Need for concurrent surgery for other diseases.
- Pregnant or breastfeeding women.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, 400038
Yan Shi, 13752909448, Shiyan@163.com
- Recruiting
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, 400038
13752909448, Shiyan@163.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study of Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
This [Study Type: Clinical Trial] aims to [Primary Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer] in [Participant Population: patients with locally advanced gastric cancer, aged >18 years and <75 years]. The primary questions it seeks to answer are:
Is the 3-year disease-free survival rate of robotic gastrectomy non-inferior to that of laparoscopic gastrectomy? Is the perioperative safety of robotic gastrectomy superior to that of laparoscopic gastrectomy? Researchers will compare [Intervention Groups: Robotic Gastrectomy vs. Laparoscopic Gastrectomy] to determine whether [robotic surgery offers advantages in long-term efficacy and perioperative safety].
Read more
Participants will:
Sign an informed consent form and be randomly assigned to either the robotic surgery group or the laparoscopic surgery group.
Undergo the assigned surgical procedure and receive regular follow-up visits (at 30 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 2 years, 2.5 years, and 3 years postoperatively).
Complete physical examinations, blood tests (including complete blood count, biochemical markers, and tumor markers), and imaging studies (such as abdominal CT, upper gastrointestinal endoscopy, and chest X-ray) during the follow-up period.
- Being tested
- Robotic Gastrectomy, Laparoscopic Gastrectomy
- Keywords
- Robotic Gastrectomy, 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.
Robotic GastrectomyProcedure or surgery
The intervention measures for robotic gastrectomy include:
Preoperative Preparation: Comprehensive preoperative examinations, including imaging studies, laboratory tests, and tumor marker assessments, to confirm the diagnosis and staging.
Surgical Procedure: Utilizing the da Vinci Surgical System, which provides a high-definition 3D view and flexible robotic arms for enhanced surgical precision.
Lymphadenectomy: Systematic D2 lymph node dissection according to oncological standards to ensure thorough removal of regional lymph nodes.
Gastrectomy and Reconstruction: Performing subtotal or total gastrectomy based on tumor location and extent, with intracorporeal reconstruction assisted by the robotic system.
Postoperative Management: Close monitoring of vital signs, pain management, and early mobilization to facilitate recovery, along with prevention and management of postoperative complications.
Laparoscopic GastrectomyProcedure or surgery
Preoperative Preparation: Confirm diagnosis and staging through imaging and laboratory tests.
Surgical Procedure: Use standard laparoscopic instruments and 2D HD camera. Lymphadenectomy: Perform systematic D2 lymph node dissection. Gastrectomy and Reconstruction: Conduct subtotal or total gastrectomy and intracorporeal reconstruction.
Postoperative Management: Monitor vital signs, manage pain, and promote early mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Gastrectomy | Experimental | Not described Receives: Procedure: Robotic Gastrectomy |
| Laparoscopic Gastrectomy | Active comparator | Not described Receives: Procedure: Laparoscopic Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival rate
Measured: 3 years
Secondary outcomes (4)
Overall postoperative complication rate
Measured: 3 years
Intraoperative complication rate
Measured: 3 years
Overall postoperative complication rate of Clavien-Dindo Grade II or higher
Measured: 3 years
3-year OS rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, Gastroesophageal Junction 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
- None (open label)
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Shi, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791538
- Sponsor's protocol ID
- SYRL-01
- Status last verified
- Jun 2025
- First submitted
- 19 Jan 2025
- Last updated
- 8 Jun 2025
- 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 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Clinical Study of Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06791538
- Acronym / sponsor ID
- SYRL-01
- Keywords
- Robotic Gastrectomy, Laparoscopic Gastrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 24 Jan 2025 (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.
This [Study Type: Clinical Trial] aims to [Primary Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer] in [Participant Population: patients with locally advanced gastric cancer, aged >18 years and <75 years]. The primary questions it seeks to answer are:
Is the 3-year disease-free survival rate of robotic gastrectomy non-inferior to that of laparoscopic gastrectomy? Is the perioperative safety of robotic gastrectomy superior to that of laparoscopic gastrectomy? Researchers will compare [Intervention Groups: Robotic Gastrectomy vs. Laparoscopic Gastrectomy] to determine whether [robotic surgery offers advantages in long-term efficacy and perioperative safety].
Participants will:
Sign an informed consent form and be randomly assigned to either the robotic surgery group or the laparoscopic surgery group.
Undergo the assigned surgical procedure and receive regular follow-up visits (at 30 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 2 years, 2.5 years, and 3 years postoperatively).
Complete physical examinations, blood tests (including complete blood count, biochemical markers, and tumor markers), and imaging studies (such as abdominal CT, upper gastrointestinal endoscopy, and chest X-ray) during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Gastrectomy | Experimental | Procedure: Robotic Gastrectomy |
| Laparoscopic Gastrectomy | Active comparator | Procedure: Laparoscopic Gastrectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years and < 75 years.
- Primary gastric lesion histologically confirmed as gastric adenocarcinoma (including papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, etc.) via endoscopic biopsy.
- Preoperative clinical staging as locally advanced gastric cancer (cT2-4a, N0-3, M0) according to the 8th edition of the AJCC TNM staging system.
- No distant metastasis on preoperative examination, and no direct invasion of the pancreas, spleen, or other adjacent organs.
- Preoperative ECOG performance status score of 0 or 1.
Key exclusion criteria (14 listed)
- Previous history of gastric malignancy surgery, including submucosal resection and/or endoscopic mucosal resection.
- History of upper abdominal surgery (excluding laparoscopic cholecystectomy).
- Preoperative imaging shows regional lymph nodes with confluent enlargement (maximum diameter ≥3cm).
- Patient underwent emergency surgery due to gastric tumor bleeding or perforation.
- History of other malignancies, or presence of other malignant tumors detected during preoperative examination.
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 |
|---|---|---|
| Robotic GastrectomyThe intervention measures for robotic gastrectomy include: Preoperative Preparation: Comprehensive preoperative examinations, including imaging studies, laboratory tests, and tumor marker assessments, to confirm the diagnosis and staging. Surgical Procedure: Utilizing the da Vinci Surgical System, which provides a high-definition 3D view and flexible robotic arms for enhanced surgical precision. Lymphadenectomy: Systematic D2 lymph node dissection according to oncological standards to ensure thorough removal of regional lymph nodes. Gastrectomy and Reconstruction: Performing subtotal or total gastrectomy based on tumor location and extent, with intracorporeal reconstruction assisted by the robotic system. Postoperative Management: Close monitoring of vital signs, pain management, and early mobilization to facilitate recovery, along with prevention and management of postoperative complications. | Procedure or surgery | Robotic Gastrectomy |
| Laparoscopic GastrectomyPreoperative Preparation: Confirm diagnosis and staging through imaging and laboratory tests. Surgical Procedure: Use standard laparoscopic instruments and 2D HD camera. Lymphadenectomy: Perform systematic D2 lymph node dissection. Gastrectomy and Reconstruction: Conduct subtotal or total gastrectomy and intracorporeal reconstruction. Postoperative Management: Monitor vital signs, manage pain, and promote early mobilization. | Procedure or surgery | Laparoscopic Gastrectomy |
Primary outcome
3-year disease-free survival rate
Time frame: 3 years
4 secondary outcomes
Overall postoperative complication rate
Time frame: 3 years
Intraoperative complication rate
Time frame: 3 years
Overall postoperative complication rate of Clavien-Dindo Grade II or higher
Time frame: 3 years
3-year OS rate
Time frame: 3 years
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 8 Jun 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Gastrectomy and Laparoscopic Gastrectomy in people with Gastric Cancer, Gastroesophageal Junction Cancer, run by Southwest Hospital, China at 2 sites in China.
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 7 inclusion and 14 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 8 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 2 sites in China. 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?
Contact Yan Shi (13752909448, shiyandoctor@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival rate (time frame: 3 years). 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 8 Jun 2025.