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

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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06881043
Acronym
STARS-GC09
Enrollment
300
Registered
2025-03-18
Start date
2024-11-20
Completion date
2029-12-01
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Adenocarcinoma, Locally Advanced Gastric Cancer

Keywords

Robot-assisted surgery, Vessel sealer extend, Gastrectomy, Laparoscopic-assisted surgery, Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases

Brief 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. 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.

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.

Interventions

None listed

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER
Jiangsu Cancer Institute & Hospital
CollaboratorOTHER
Beijing Tsinghua Changgeng Hospital
CollaboratorOTHER
First People's Hospital of Hangzhou
CollaboratorOTHER
Beijing Hospital
CollaboratorOTHER_GOV
The First Affiliated Hospital of Bengbu Medical University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Overall postoperative morbidity ratesWithin 30 days after surgeryOverall complication rates within 30 days after surgery in patients.

Secondary

MeasureTime frameDescription
comprehensive complication index, CCIWithin 30 days after surgeryIt was calculated according to the severity of surgical complications.
Intraoperative morbidity ratesWithin 30 days after surgeryThe 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.
Overall postoperative serious morbidity ratesWithin 30 days after surgeryAccording 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.
Number of retrieved lymph nodesWithin 30 days after surgeryThe total number of harvested lymph nodes was confirmed by pathology.
Postoperative recoveryWithin 30 days after surgeryThe recovery of patients after surgery, including physical and functional recovery, etc.
Postoperative prealbumin36 monthsBlood examination
Postoperative albumin36 monthsBlood examination
Inflammatory reponsesWithin 30 days after surgeryWBC, blood examination
Immune responseWithin 30 days after surgeryIL-6, blood examination
Surgical costsWithin 30 days after surgeryThe cost of the patient's surgical treatment.
3-years disease free survival ratesFollow-up evaluations are performed up to 3 years postoperatively.The rate of 3-year disease free survival rates
3-year overall survival ratesFollow-up evaluations are performed up to 3 years postoperatively.The rate of 3-year overall survival rate

Countries

China

Contacts

CONTACTQuan Wang, Professor
wquan@jlu.edu.cn+86 15843073207

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026