NCT06881043Toboroz
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 31.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 300 (tervezett)
- Első benyújtás
- 2025. márc. 3.
- Kezdés
- 2024. nov. 20.
- Elsődleges befejezés
- 2026. dec. 1.
- Fő szponzor
- The First Hospital of Jilin University
- Betegségek
- Gyomor- és nyelőcsőrák
- NCT-szám
- NCT06881043
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 300
- 2024. nov. 20. és az elsődleges befejezés (2026. dec. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
- History of previous neoadjuvant chemotherapy or radiotherapy
- Preoperative evaluation requires combined organ resection
Más betegség
- Gastric multiple primary carcinoma or multiple primary cancer
- History of other malignant disease within the past 5 years
- 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
- Severe mental disorder
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- Requirement of simultaneous surgery for other disease
Egyéb
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
- FEV1<50% of the predicted values
- Women during pregnancy or breast-feeding
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| First Hospital of Jilin University | Changchun | Kína | Toboroz |
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