Clinical trial · Observational
Comparison of Short- and Long-term Efficacy of Robotic Versus Laparoscopic Gastrectomy in High-risk Patients With Gastric Cancer: a Nationwide, Multicentre Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Since 2007, robotic gastrectomy (RG) has been considered an option for minimally invasive surgery (MIS)1. In recent years, several randomised trials and retrospective studies have compared short-term efficacy and oncological outcomes between RG and laparoscopic gastrectomy (LG)2-5. Compared with traditional laparoscopic gastric surgery, RG may yield better short-term and comparable long-term outcomes4-6. According to previous studies7, 8, American Society of Anesthesiologists (ASA) grade ≥3, body mass index (BMI) ≥ 30 kg/m2, age ≥80 years, and clinical T4 stage are considered to be sensitive indicators for assessing surgical risk among patients with cancer. Patients with any of these factors were defined as high risk patients who constitute a special group. Previous research has shown that obesity, advanced age, comorbid conditions, and tumour cT stage are factors associated with mortality and complication rates in MIS for gastrointestinal malignancies6,7. Therefore, it is crucial to explore the impact of high-risk factors on prognosis. Many elderly patients have comorbidities with a high incidence of cardiopulmonary disease(s)8-10. Moreover, patients with poor baseline conditions often struggle to tolerate major surgery, and their comorbid state and ASA score are high-risk factors that affect postoperative complications and prognosis11-14. High BMI, especially among obese patients in whom excessive abdominal fat obscures anatomical regions, limits the flexibility of laparoscopic instruments, hinders complex perivascular lymph node dissection, and increases the difficulty of D2 lymphadenectomy, may increase postoperative complications15-17. Advanced-stage tumours, particularly those at the cT4 stage, present with more enlarged metastatic lymph nodes, making the exposure of vessels and dissection more challenging6,7. All of these factors are considered to be high-risk factors for surgical procedures. With the increasing prevalence of aging populations and obesity18-20, more high-risk patients with resectable gastric cancer (GC) are undergoing MIS. To further explore this increasing concern about clinical practice, our study is the first to compare the short- and long-term outcomes of RG and LG in a high-risk gastric cancer population, with the aim of providing high-level, evidence-based medicine for the widespread application of RG in this population. To the best of our knowledge, this is the first multicentre, large-sample study to compare the advantages of RG and LG in a high-risk GC population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With More Than or Equal to One of the Following Criteria Were Defined as High-risk Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The da Vinci robotic system (Intuitive Surgical, Inc., Sunnyvale, CA, USA) was used for all robotic gastrectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- laparoscopic group
- description
- patients underwent laparoscopic gastrectomy
- interventionNames
- Device: The da Vinci robotic system (Intuitive Surgical, Inc., Sunnyvale, CA, USA) was used for all robotic gastrectomy
Primary outcomes (1)
- measure
- The main endpoints of this study were the 3-year cumulative incidence function (3y-CIF) of three-year mortality under a competing risk model, and 3-year disease-free survival (3y-DFS) with secondary outcomes, including three-year recurrence patterns.
- timeFrame
- 3 years
- description
- DFS was estimated using the Kaplan-Meier method, and comparisons were performed using the log-rank test. Given the high-risk population in this study, in which non-tumour-related deaths may occur, a competing risk model was used to analyse prognosis more accurately by excluding non-tumor-related deaths. CIFs were estimated using the competing risk model, and comparisons were performed using the Fine-Gray test. For recurrence, all-cause mortality was considered a competing event, and cumulative recurrence rates were calculated using a competing risk model.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * postoperative pathological staging of T1-4aN0-3bM0 gastric adenocarcinoma; and radical gastrectomy with gastric lymph node dissection. According to previous studies7, 8, American Society of Anesthesiologists (ASA) grade ≥3, body mass index (BMI) ≥ 30 kg/m2, age ≥80 years, and clinical T4 stage are considered to be sensitive indicators for assessing surgical risk among patients with cancer Exclusion Criteria: * Exclusion criteria included: residual gastric cancer ; concurrent/past malignancies ; loss to follow-up ; previous indocyanine green-guided lymph node dissection ; undergoing neoadjuvant chemotherapy; and patients without high-risk factors . These inclusion criteria identified 2 001 patients for baseline analysis.
References
Publications (0)
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