Stomach NeoplasmsNCT07586384
Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial
A study testing Single-Port Robotic Surgical System and Traditional Laparoscopic Surgery in people with Stomach Neoplasms and Robotic Surgical Procedures, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms, Robotic Surgical Procedures
- What is being tested?
- Single-Port Robotic Surgical System and Traditional Laparoscopic Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2025to 30 Sep 2027
- 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
- Age between 18 and 75 years inclusive.
- ECOG performance status ≤ 2.
- Histologically confirmed proximal gastric cancer or Siewert type II adenocarcinoma of the esophagogastric junction.
- Clinical stage cT1-T3, N0-N+, M0.
- Tumor maximum diameter ≤ 4 cm and esophageal invasion ≤ 2 cm.
- Candidates for radical proximal gastrectomy (PG) with feasibility of R0 resection and functional anastomosis.
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- Assessed by a Multidisciplinary Team (MDT) as suitable for PG rather than total gastrectomy, with no requirement for neoadjuvant therapy.
- Radiographic evidence of localized disease (no distant metastasis to liver, lung, or peritoneum via enhanced CT or MRI).
- ASA physical status classification ≤ III.
- Adequate bone marrow, hepatic, renal, cardiac, and pulmonary function.
- Ability to understand and provide written informed consent.
- Willingness and ability to comply with the 12-month postoperative follow-up schedule.
Who cannot join
- Clinical stage T4 or presence of distant metastasis.
- Esophageal invasion exceeding 2 cm.
- History of previous major gastric surgery (e.g., partial or total gastrectomy).
- Other malignant tumors within the last 5 years.
- Severe organic diseases that preclude safe anesthesia or surgery (e.g., severe heart failure, pulmonary fibrosis).
- Requirement for emergency surgery due to active gastric bleeding, perforation, or acute obstruction.
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- Pregnant or lactating women.
- Serious psychiatric disorders or cognitive impairment that interferes with study compliance.
- Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Xian Shen, +86 139 6888 8872, shenxian1120@126.com
About this study
Official title: A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer
To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.
- Conditions
- Stomach Neoplasms, Robotic Surgical Procedures
- Being tested
- Single-Port Robotic Surgical System, Traditional Laparoscopic Surgery
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Port Robotic Surgical SystemDevice
An investigational robotic-assisted surgical platform designed for single-port access. In this study, the system is utilized to perform radical proximal gastrectomy. The core surgical procedures are conducted through a centralized access point to assess the intraoperative safety and short-term clinical outcomes of this robotic-assisted approach.
Traditional Laparoscopic SurgeryProcedure or surgery
Standard multi-port laparoscopic radical proximal gastrectomy performed as a clinical control. This procedure follows conventional laparoscopic techniques involving multiple abdominal incisions for the placement of surgical instruments and camera to treat proximal gastric cancer.
| Study group | Role | What they receive |
|---|---|---|
| Single-Port Group | Experimental | Participants in this group will undergo radical proximal gastrectomy utilizing the SP1000 single-port surgical platform. The procedure focuses on performing the main surgical maneuvers through a centralized access point to evaluate the safety and clinical performance of the robotic system. Receives: Device: Single-Port Robotic Surgical System |
| Traditional Laparoscopy Group | Active comparator | Not described Receives: Procedure: Traditional Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)
The proportion of participants experiencing at least one postoperative complication graded II or higher according to the Clavien-Dindo Classification. This includes surgery-related, systemic, and anesthesia-related complications. If a patient experiences multiple complications, only the most severe grade will be used for statistical analysis.
Measured: Within 30 days postoperatively.
Secondary outcomes (4)
Estimated Blood Loss
The amount of blood lost during the surgical procedure, measured in milliliters (mL).
Measured: During the surgical procedure (Day 0).
Time to First Flatus
The time from the end of surgery until the participant's first passage of flatus, measured in days.
Measured: Up to 30 days postoperatively.
Total Operation Time
The duration from the initial skin incision to the completion of skin closure, measured in minutes.
Measured: During the surgical procedure (Day 0).
Conversion Rate
The proportion of participants in the Single-Port group who require conversion to traditional multi-port laparoscopy or open surgery due to technical or safety factors.
Measured: During the surgical procedure (Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start5 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586384
- Sponsor's protocol ID
- KY2025-143
- Other IDs
- ChiCTR2500109905
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer
- ClinicalTrials.gov ID
- NCT07586384
- Acronym / sponsor ID
- KY2025-143
- Conditions
- Stomach Neoplasms, Robotic Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 May 2026 (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.
To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Port Group | Experimental | Device: Single-Port Robotic Surgical SystemParticipants in this group will undergo radical proximal gastrectomy utilizing the SP1000 single-port surgical platform. The procedure focuses on performing the main surgical maneuvers through a centralized access point to evaluate the safety and clinical performance of the robotic system. |
| Traditional Laparoscopy Group | Active comparator | Procedure: Traditional Laparoscopic Surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 75 years inclusive.
- ECOG performance status ≤ 2.
- Histologically confirmed proximal gastric cancer or Siewert type II adenocarcinoma of the esophagogastric junction.
- Clinical stage cT1-T3, N0-N+, M0.
- Tumor maximum diameter ≤ 4 cm and esophageal invasion ≤ 2 cm.
Key exclusion criteria (9 listed)
- Clinical stage T4 or presence of distant metastasis.
- Esophageal invasion exceeding 2 cm.
- History of previous major gastric surgery (e.g., partial or total gastrectomy).
- Other malignant tumors within the last 5 years.
- Severe organic diseases that preclude safe anesthesia or surgery (e.g., severe heart failure, pulmonary fibrosis).
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 |
|---|---|---|
| Single-Port Robotic Surgical SystemAn investigational robotic-assisted surgical platform designed for single-port access. In this study, the system is utilized to perform radical proximal gastrectomy. The core surgical procedures are conducted through a centralized access point to assess the intraoperative safety and short-term clinical outcomes of this robotic-assisted approach. | Device | Single-Port Group |
| Traditional Laparoscopic SurgeryStandard multi-port laparoscopic radical proximal gastrectomy performed as a clinical control. This procedure follows conventional laparoscopic techniques involving multiple abdominal incisions for the placement of surgical instruments and camera to treat proximal gastric cancer. | Procedure or surgery | Traditional Laparoscopy Group |
Primary outcome
Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)
Time frame: Within 30 days postoperatively.
The proportion of participants experiencing at least one postoperative complication graded II or higher according to the Clavien-Dindo Classification. This includes surgery-related, systemic, and anesthesia-related complications. If a patient experiences multiple complications, only the most severe grade will be used for statistical analysis.
4 secondary outcomes
Estimated Blood Loss
Time frame: During the surgical procedure (Day 0).
Time to First Flatus
Time frame: Up to 30 days postoperatively.
Total Operation Time
Time frame: During the surgical procedure (Day 0).
Conversion Rate
Time frame: During the surgical procedure (Day 0).
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 14 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Port Robotic Surgical System and Traditional Laparoscopic Surgery in people with Stomach Neoplasms and Robotic Surgical Procedures, run by First Affiliated Hospital of Wenzhou Medical University at 1 site 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 12 inclusion and 9 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 14 May 2026. 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 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 Xian Shen (+86 139 6888 8872, shenxian1120@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II) (time frame: Within 30 days postoperatively.). 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 14 May 2026.