Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603272
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Comparison of Short- and Long-term Efficacy of Robotic Versus Laparoscopic Gastrectomy in High-risk Patients With Gastric Cancer a Nationwide Multicentre Cohort Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Short- and Long-term Efficacy of Robotic Versus Laparoscopic Gastrectomy in High-risk Patients With Gastric Cancer a Nationwide Multicentre Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RL2023
Brief Summary:
Since 2007 robotic gastrectomy RG has been considered an option for minimally invasive surgery MIS1 In recent years several randomised trials and retrospective studies have compared short-term efficacy and oncological outcomes between RG and laparoscopic gastrectomy LG2-5 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 kgm2 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 malignancies67 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 diseases8-10 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 challenging67 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
According to previous studies7 8 American Society of Anesthesiologists ASA grade 3 body mass index BMI 30 kgm2 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 malignancies67 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 diseases8-10 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 challenging67 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
Detailed Description:
A retrospective collection of clinical pathological and follow-up data was conducted on 1 103 patients who underwent radical RG and 2 515 who underwent radical LG at eight high-volume tertiary hospitals in China between August 2016 and June 2019
The inclusion criteria were as follows postoperative pathological staging of T1-4aN0-3bM0 gastric adenocarcinoma and radical gastrectomy with gastric lymph node dissection Exclusion criteria included residual gastric cancer n52 concurrentpast malignancies n 58 loss to follow-up n 123 previous indocyanine green-guided lymph node dissection n 125 undergoing neoadjuvant chemotherapy n 144 RG group n 7 LG group n 137 and patients without high-risk factors n 1617 These inclusion criteria identified 2 001 patients for baseline analysis The study was approved by the institutional review board of each participating centre
Propensity score matching and sample size Propensity score matching PSM was used to adjust for the different baseline characteristics between the RG and LG groups A 11 ratio PSM was performed using the nearest neighbour matching method with a caliper of 02 Fourteen factors including age ASA class previous abdominal surgery tumour size tumour location resection extent extent of lymphadenectomy histology cT cN pT pN and adjuvant chemotherapy were includedUltimately data from 1 068 patients were included in the analysis eFig 1 The balance of matching between the two groups was assessed using the standardised mean difference SMD with a value lt 01 considered to be acceptable
Surgical quality control and perioperative management All surgeons participating in this study were from high-capacity tertiary referral centres and surpassed the learning curve associated with LG The da Vinci robotic system Intuitive Surgical Inc Sunnyvale CA USA was used for all RGs with surgeons receiving standardised RG training and operational certification
Surgical intervention was initiated after obtaining informed consent from all patients which included the additional costs of robotic surgery a comprehensive explanation of surgical risks and potential alternative treatments thus facilitating informed surgical approach choices ie LG or RG within the participating institutions Adherence to the Japanese Gastric Cancer Treatment Guidelines was maintained for determining the extent of gastrectomy and lymphadenectomy2122 RG operating procedures are similar to LG in terms of trocar placement surgical phases and anastomosis techniques with detailed procedural delineations available elsewhere223 Postoperative morbidity and mortality were assessed within a 30-day framework using the Clavien-Dindo classification system24 Complications were categorised as surgical and systemic and were defined based on previous descriptions25 with intraoperative blood loss 400 ml defined as massive haemorrhage in accordance with the existing literature26
Each surgical specimen was subjected to macroscopic and histological examination by two experienced pathologists with TNM staging according to the 8th Edition of the American Joint Committee on Cancer staging system27 Any disparities were resolved by a third pathologist Patients with stage II disease without contraindications to chemotherapy were recommended postoperative adjuvant chemotherapy based on 5-fluorouracil ie 5-FU2128 with all adjuvant chemotherapy regimens and dosages formulated by experienced oncologists adaptable to patient responsiveness and chemotherapy toxicity
Follow-up and surveillance Follow-up evaluations included physical examinations comprehensive laboratory investigations chest computed tomography CT abdominal ultrasoundCT scans with contrast enhancement and annual gastroscopy Patients were followed up once every 3 to 6 months in the first two years and every 6 to 12 months within the next 3 to 5 years Follow-up telephone calls were used as supplements to outpatient reviews and medical insurance systems to monitor patient survival recurrence and mortality The multicentre inclusion resulted in variable final follow-up durations across centres Surviving patients achieved follow-up durations 36 months
Primary outcomes and definitions 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
The CIF refers to the adjusted mortality rate of non-gastric cancer-related deaths from the date of surgery to the date of the last follow-up29 30 DFS was defined as the time from the date of surgery to the date of recurrence death or last follow-up without recurrence The diagnosis of recurrence was based on radiologically or biopsy-confirmed suspicious lesions Recurrence types were categorised as local including local sites such as the gastric bed or anastomotic site peritoneal hepatic multisite and other uncertain locations Multisite recurrence involves simultaneous recurrence at 2 sites including the peritoneum liver lungs bones brain distant lymph nodes and other sites of haematogenous spread Other uncertain locations encompassed vascular recurrences outside the liver eg lungs bones brain adrenal glands distant lymph node recurrences and recurrences of uncertain origin3132
The inclusion criteria were as follows postoperative pathological staging of T1-4aN0-3bM0 gastric adenocarcinoma and radical gastrectomy with gastric lymph node dissection Exclusion criteria included residual gastric cancer n52 concurrentpast malignancies n 58 loss to follow-up n 123 previous indocyanine green-guided lymph node dissection n 125 undergoing neoadjuvant chemotherapy n 144 RG group n 7 LG group n 137 and patients without high-risk factors n 1617 These inclusion criteria identified 2 001 patients for baseline analysis The study was approved by the institutional review board of each participating centre
Propensity score matching and sample size Propensity score matching PSM was used to adjust for the different baseline characteristics between the RG and LG groups A 11 ratio PSM was performed using the nearest neighbour matching method with a caliper of 02 Fourteen factors including age ASA class previous abdominal surgery tumour size tumour location resection extent extent of lymphadenectomy histology cT cN pT pN and adjuvant chemotherapy were includedUltimately data from 1 068 patients were included in the analysis eFig 1 The balance of matching between the two groups was assessed using the standardised mean difference SMD with a value lt 01 considered to be acceptable
Surgical quality control and perioperative management All surgeons participating in this study were from high-capacity tertiary referral centres and surpassed the learning curve associated with LG The da Vinci robotic system Intuitive Surgical Inc Sunnyvale CA USA was used for all RGs with surgeons receiving standardised RG training and operational certification
Surgical intervention was initiated after obtaining informed consent from all patients which included the additional costs of robotic surgery a comprehensive explanation of surgical risks and potential alternative treatments thus facilitating informed surgical approach choices ie LG or RG within the participating institutions Adherence to the Japanese Gastric Cancer Treatment Guidelines was maintained for determining the extent of gastrectomy and lymphadenectomy2122 RG operating procedures are similar to LG in terms of trocar placement surgical phases and anastomosis techniques with detailed procedural delineations available elsewhere223 Postoperative morbidity and mortality were assessed within a 30-day framework using the Clavien-Dindo classification system24 Complications were categorised as surgical and systemic and were defined based on previous descriptions25 with intraoperative blood loss 400 ml defined as massive haemorrhage in accordance with the existing literature26
Each surgical specimen was subjected to macroscopic and histological examination by two experienced pathologists with TNM staging according to the 8th Edition of the American Joint Committee on Cancer staging system27 Any disparities were resolved by a third pathologist Patients with stage II disease without contraindications to chemotherapy were recommended postoperative adjuvant chemotherapy based on 5-fluorouracil ie 5-FU2128 with all adjuvant chemotherapy regimens and dosages formulated by experienced oncologists adaptable to patient responsiveness and chemotherapy toxicity
Follow-up and surveillance Follow-up evaluations included physical examinations comprehensive laboratory investigations chest computed tomography CT abdominal ultrasoundCT scans with contrast enhancement and annual gastroscopy Patients were followed up once every 3 to 6 months in the first two years and every 6 to 12 months within the next 3 to 5 years Follow-up telephone calls were used as supplements to outpatient reviews and medical insurance systems to monitor patient survival recurrence and mortality The multicentre inclusion resulted in variable final follow-up durations across centres Surviving patients achieved follow-up durations 36 months
Primary outcomes and definitions 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
The CIF refers to the adjusted mortality rate of non-gastric cancer-related deaths from the date of surgery to the date of the last follow-up29 30 DFS was defined as the time from the date of surgery to the date of recurrence death or last follow-up without recurrence The diagnosis of recurrence was based on radiologically or biopsy-confirmed suspicious lesions Recurrence types were categorised as local including local sites such as the gastric bed or anastomotic site peritoneal hepatic multisite and other uncertain locations Multisite recurrence involves simultaneous recurrence at 2 sites including the peritoneum liver lungs bones brain distant lymph nodes and other sites of haematogenous spread Other uncertain locations encompassed vascular recurrences outside the liver eg lungs bones brain adrenal glands distant lymph node recurrences and recurrences of uncertain origin3132
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None