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Locally Advanced Gastric CancerSTARS-GC09NCT06881043

The Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer

An observational study of Locally Advanced Gastric Cancer and Gastric Adenocarcinoma, run by The First Hospital of Jilin University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Gastric cancer is the fifth most common malignancy and the fourth leading cause of cancer-related deaths. Surgical resection is the primary treatment, with laparoscopic-assisted gastrectomy (LG) being a minimally invasive option. Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
300 participants
Where
1 siteChina
Study dates
20 Nov 2024to 1 Dec 2029
How long will I take part?
3 Years
Phase
Observational
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

Study population: Patients with Primary gastric adenocarcinoma at the stage of cT2-4a, N-/+, M0.

Who may be able to join

  • Age from over 18 to under 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT2-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • Preoperative abdominal enhanced CT and lung CT (or PET-CT) showed no distant metastasis
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) class I to III
  • Written informed consent

Who cannot join

  • Gastric multiple primary carcinoma or multiple primary cancer
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection ) for gastric cancer)
  • Preoperative gastric CT evaluation and chest and abdominal imaging evaluation were not performed before surgery, and the clinical stage of the tumor was not comprehensively evaluated
  • Enlarged or bulky regional lymph node (diameter over 3cm)supported by preoperative imaging
  • History of other malignant disease within the past 5 years
Show all 16Show fewer
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within the past 6 months
  • History of cerebrovascular accident within the past 6 months
  • History of continuous systematic administration of corticosteroids within 1 month
  • FEV1<50% of the predicted values
  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • Preoperative evaluation requires combined organ resection
  • Requirement of simultaneous surgery for other disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Quan Wang, Professor contact

+86 15843073207

wquan@jlu.edu.cn

China1 site, 1 recruiting
  • First Hospital of Jilin University

    Changchun, Jilin, 130012

    Quan Wang, +86 15843073207, wquan@jlu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Prospective, Observational Cohort Study to Assess the Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer (STARS-GC09)

Gastric cancer is the fifth most common malignancy and the fourth leading cause of cancer-related deaths. Surgical resection is the primary treatment, with laparoscopic-assisted gastrectomy (LG) being a minimally invasive option. However, LG is limited by restricted instrument mobility and hand tremors, which affect precision. The Da Vinci robotic system enhances surgical precision with 3D magnification, improved hand-eye coordination, tremor filtration, and flexible instruments. It is especially beneficial in complex procedures like D2 lymph node dissection and lower mediastinal lymph node clearance. Unlike laparoscopic surgery, robotic surgery offers superior flexibility and reduced pancreatic injury during dissection. Robotic-assisted gastrectomy (RG) offers advantages over LG, such as reduced blood loss, shorter hospital stays, and improved lymph node dissection. However, its short-term benefits remain debated, and most studies focus on early gastric cancer. The safety and efficacy of RG for advanced gastric cancer are not well-established.

Vascular coagulation is crucial in minimally invasive surgery. Ultrasonic devices, though widely used, can cause thermal damage due to high temperatures. In contrast, the Vessel Sealer Extend (VSE) offers greater flexibility and precision. It allows 540° instrument rotation, coagulates vessels up to 7 mm in diameter with lower energy, and minimizes thermal injury. Retrospective studies show RG with VSE may have faster recovery and fewer complications than LG. However, further prospective, multicenter studies are needed to confirm these benefits for advanced gastric cancer.

The investigators propose a multicenter, observational study to evaluate RG with VSE in advanced gastric cancer, assessing safety, recovery, and oncological outcomes.

Read the detailed description

Gastric cancer is the fifth most common malignancy worldwide and the fourth leading cause of cancer-related deaths. Surgical resection remains the primary treatment for the radical management of gastric cancer. Laparoscopic-assisted gastrectomy (LG) has proven to be a minimally invasive and safe approach for both early-stage and advanced gastric cancer, offering significant advantages over open surgery. However, LG is still limited by factors such as the restricted range of motion of straight forceps and the impact of hand tremors on surgical precision. These challenges necessitate the development of more advanced techniques. The Da Vinci robotic surgical system plays a critical role in enhancing the precision of robotic surgeries. It provides a three-dimensional, ten-fold magnified view of the surgical area, promotes natural hand-eye coordination, filters hand tremors, and allows for greater freedom of movement with its articulated instruments. The benefits of the Da Vinci system have been proved in complex procedures such as D2 lymph node dissection for gastric cancer and lower mediastinal lymph node dissection. For example, during lower mediastinal lymph node dissection in adenocarcinoma of the gastroesophageal junction, the limited field of view of laparoscopic surgery restricts the use of linear instruments, whereas the flexibility of robotic surgery offers an advantage. Furthermore, peripancreatic lymph node clearance in radical gastric cancer surgery presents a challenge. LG is prone to causing pancreatic injury during dissection due to the fixed trocar positions and the rigidity of linear energy instruments, which can result in complications such as postoperative pancreatic fistulas and abdominal abscesses. The incidence of pancreatic fistulas after LG exceeds 5%, and higher amylase levels in drainage fluid suggest potential subclinical pancreatic injury. In contrast, robotic-assisted gastrectomy (RG) has evolved rapidly and offers advantages such as reduced pancreatic compression during dissection and a lower risk of thermal injury during lymph node removal. Retrospective studies suggest that RG is associated with less blood loss, shorter hospital stays, and improved lymph node dissection compared to LG. However, the evidence regarding the superiority of RG in terms of short-term outcomes remains controversial, as some prospective studies and meta-analyses have not confirmed its benefits. Prospective studies mainly focused on early gastric cancer, whereas the safety, efficacy, and cost-effectiveness of RG in advanced gastric cancer are still unclear.

Vascular coagulation is the key of minimally invasive surgery. In current robotic procedures, ultrasonic energy devices have been widely used. However, they lack flexibility and can generate high operating temperatures (up to 200°C), which risks thermal damage to surrounding tissues. Park et al. demonstrated that LG using bipolar energy devices resulted in lower postoperative C-reactive protein levels and reduced blood loss compared to ultrasonic scalpel use. The bipolar vascular closure system (Vessel Sealer Extend, VSE) is an advanced bipolar energy device with a fully articulated wrist joint, enabling 540° rotation and multi-directional access to vessels and target anatomical sites. The textured inner surface of the jaws enhances tissue grip, and it can coagulate vessels up to 7 mm in diameter with lower energy, minimizing thermal damage to adjacent structures. Retrospective studies have shown that robotic distal gastrectomy using VSE has earlier resumption of a semi-liquid diet (4.0 vs. 4.2 days, p=0.03) and a significantly lower incidence of postoperative intestinal obstruction (0% vs. 9.9%, p=0.03) compared to conventional laparoscopic surgery. The VSE has also demonstrated benefits in other surgical procedure. Yang et al. found that VSE use in robotic thyroidectomy reduced the frequency of camera cleaning compared to the Harmonic energy device (0.55 ± 0.51 vs. 1.93 ± 1.71, p<0.05). Additionally, a study comparing different robotic instrument combinations for adrenalectomy found that the VSE in combination with monopolar curved scissors offered the best performance. Based on these findings, the investigators believe that the VSE energy device could optimize RG, improving both safety and postoperative recovery.

There is a lack of prospective, multicenter, high-quality studies to verify the safety and recovery benefits associated with reduced thermal damage using this novel energy device. Therefore, the investigators propose a prospective, multicenter, observational cohort study to evaluate the safety, feasibility, and potential benefits of RG with the VSE energy device in the treatment of advanced gastric cancer. This study will assess postoperative recovery, inflammatory response, and oncological outcomes.

Keywords
Robot-assisted surgery, Vessel sealer extend, Gastrectomy, Laparoscopic-assisted surgery, Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
Medical subject headings
Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06881043
Study groupRoleWhat they receive
Robot-assisted radical gastrectomy using VSE for locally advanced gastric cancer.The surgeon performed robot-assisted radical gastrectomy using VSE for locally advanced gastric cancer.
laparoscopic-assisted radical gastrectomy for advanced gastric cancerThe surgeon performed laparoscopic-assisted radical gastrectomy for advanced gastric cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall postoperative morbidity rates

    Overall complication rates within 30 days after surgery in patients.

    Measured: Within 30 days after surgery

Secondary outcomes (13)
  1. comprehensive complication index, CCI

    It was calculated according to the severity of surgical complications.

    Measured: Within 30 days after surgery

  2. Intraoperative morbidity rates

    The number of patients who received surgical treatment was used as the denominator, and the number of patients with intraoperative complications was used as the numerator.

    Measured: Within 30 days after surgery

  3. Overall postoperative serious morbidity rates

    According to the Clavien Dindo complication scoring system, IIIa and above were considered as severe complications, and when multiple complications occurred at the same time, the complication with the highest grade was considered.

    Measured: Within 30 days after surgery

  4. Number of retrieved lymph nodes

    The total number of harvested lymph nodes was confirmed by pathology.

    Measured: Within 30 days after surgery

  5. Postoperative recovery

    The recovery of patients after surgery, including physical and functional recovery, etc.

    Measured: Within 30 days after surgery

  6. Postoperative prealbumin

    Blood examination

    Measured: 36 months

  7. Postoperative albumin

    Blood examination

    Measured: 36 months

  8. Inflammatory reponses

    WBC, blood examination

    Measured: Within 30 days after surgery

  9. Immune response

    IL-6, blood examination

    Measured: Within 30 days after surgery

  10. Immune response

    IL-10, blood examination

    Measured: Within 30 days after surgery

  11. Surgical costs

    The cost of the patient's surgical treatment.

    Measured: Within 30 days after surgery

  12. 3-years disease free survival rates

    The rate of 3-year disease free survival rates

    Measured: Follow-up evaluations are performed up to 3 years postoperatively.

  13. 3-year overall survival rates

    The rate of 3-year overall survival rate

    Measured: Follow-up evaluations are performed up to 3 years postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2025
  2. Study start20 Nov 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

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
Prospective
Enrolment
300 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06881043
Sponsor's protocol ID
STARS-GC09
Acronym
STARS-GC09
Status last verified
Aug 2026
First submitted
3 Mar 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Locally Advanced Gastric Cancer and Gastric Adenocarcinoma, run by The First Hospital of Jilin 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 7 inclusion and 16 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 31 Aug 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 Quan Wang, Professor (+86 15843073207, wquan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall postoperative morbidity rates (time frame: Within 30 days after surgery). 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 31 Aug 2026.

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