NCT06603272: RL2023

Comparison of Short- and Long-term Efficacy of Robotic Versus Laparoscopic Gastrectomy in High-risk Patients With Gastric Cancer: a Nationwide, Multicentre Cohort Study

Completed Last updated 19 September 2024

What this trial tests

trial testing The da Vinci robotic system (Intuitive Surgical, Inc., Sunnyvale, CA, USA) was used for all robotic gastrectomy in Patients With More Than or Equal to One of the Following Criteria Were Defined as High-risk Patients in 534 participants. Completed in 15 June 2023.

Timeline

1 August 2016

Primary endpoint
5 June 2019

15 June 2023

Quick facts

Lead sponsor	Fujian Medical University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	534
Start date	1 August 2016
Primary completion	5 June 2019
Estimated completion	15 June 2023

Drugs / interventions tested

• The da Vinci robotic system (Intuitive Surgical, Inc., Sunnyvale, CA, USA) was used for all robotic gastrectomy

Conditions studied

• Patients With More Than or Equal to One of the Following Criteria Were Defined as High-risk Patients — all drugs for Patients With More Than or Equal to One of the Following Criteria Were Defined as High-risk Patients →

Sponsor

Fujian Medical University

Who can join

Eligibility, any sex, with Patients With More Than or Equal to One of the Following Criteria Were Defined as High-risk Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.