ERAS for Gastric Cancer Patients After NACT

Short- and Long-term Outcomes Following Perioperative ERAS Management in Patients Undergoing Minimally Invasive Radical Gastrectomy After Neoadjuvant Chemotherapy: A Single-center Retrospective Propensity Score Matching Cohort Study

Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients.

Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Other: enhanced recovery after surgery; Other: conventional perioperative management

Detailed Description

Patients From January 2015 to October 2020, the data of 390 gastric cancer patients who underwent laparoscopic or robotic minimally invasive radical gastrectomy after NACT at the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University, were retrospectively collected and divided into ERAS group and conventional group according to whether they received perioperative ERAS pathway management.

Perioperative management and follow-up Patients in the conventional group received routine perioperative care, while patients in the ERAS group received the ERAS management protocol. Based on clinical practice, we reconsidered the total clauses in the gastric cancer ERAS pathway and determined that preoperative education, prehabilitation, target-oriented liquid management, preoperative oral carbohydrate intake, multimodal analgesia, minimally invasive surgery, physical activity, individual nutritional evaluation and support were the core terms that are suitable for all patients and should be strictly adhered to. Patients follow-up was strictly in accordance with Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).

NACT and D2 gastrectomy Due to the retrospective design of this study, data from patients who received CapOx, SOX or other 5-fluorouracil-based chemotherapy regimens were collected for analysis. If patients could not complete preoperative chemotherapy as planned due to severe adverse events or if preoperative chemotherapy needed to be prolonged for more than 4 cycles due to unsatisfactory therapeutic efficacy, their data would not be analyzed. If the original regimens were effective before surgery, they were still administered after surgery. If disease progressed after preoperative chemotherapy, subsequent regimens were discussed by a multidisciplinary team. Pre- and postoperative chemotherapy was administered in total of 8 cycles, and this treatment was adjusted according to the patient's disease condition and tolerance.

All patients underwent surgery approximately 4 weeks after the last cycle of preoperative chemotherapy. The extent of gastrectomy was determined according to the tumor location, and the extent of lymph node dissection was strictly in accordance with the D2 standard. The types of digestive tract reconstruction depended on the tumor site, extent of gastric resection, experience and surgeon habits. The choice of laparoscopy or DaVinci-assisted surgery depended on the subjective will of the patients.

Propensity score matching and statistical analysis After excluding patients who did not meet the inclusion criteria, the ERAS group was matched at a ratio of 1:1 with the conventional group including the following covariates: age, PLR, LMR, CAR and prealbumin concentration. SPSS 24.0 was used to perform the match using a 0.2 caliper width.

SPSS 24.0 (IBM, Armonk, NY, USA) was used for the data analysis. The normally distributed measurement data are expressed as mean ± standard deviation (x̅±s); the differences between groups were compared by Student's t test. Measurement data with a nonnormal distribution are presented as medians (interquartile ranges); the Mann-Whitney U test was used for comparisons between two groups. Count data are presented as absolute numbers; comparisons between groups were analyzed using the Chi-square test. The Mann-Whitney U test was used for ranked data. Repeated measures data were analyzed by two-way repeated-measures ANOVA or the generalized estimating equation. Survival curves were plotted using the Kaplan-Meier method, and the differences in survival rate were compared by the log-rank test. Univariate and multivariate analyses of risk factors for RFS and OS were conducted with the Cox proportional hazards regression model. The cutoff values of the continuous variables were determined using the median. The multivariate Cox proportional hazards regression model included variables with p < 0.15 in the univariate analysis. P < 0.05 was considered to indicate statistical significance.

• Study Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

From January 2015 to October 2020, the data of 390 gastric cancer patients who underwent laparoscopic or robotic minimally invasive radical gastrectomy after NACT at the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University, were collected and divided into ERAS group and conventional group according to whether they received perioperative ERAS pathway management.

Description

Inclusion Criteria:

• gastric adenocarcinoma confirmed by histopathology,
• received 2 to 4 cycles of NACT before surgery,
• minimally invasive (DaVinci or laparoscopy) radical gastrectomy with D2 lymph node dissection

Exclusion Criteria:

• conversion to open surgery due to intraoperative difficulties or uncontrolled complications (for example, intraoperative massive bleeding),
• inability to complete the planned preoperative chemotherapy,
• infeasibility of performing radical gastrectomy during surgery
• ERAS item implementation rate less than 60%

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERAS group	Other: enhanced recovery after surgery; ERAS is a comprehensive perioperative interventions, including preoperative patient education, prehabilitation, nutritional support, minimally invasive surgery and other methods, can reduce surgical stress and promote patient recovery
Conventional group	Other: conventional perioperative management; conventional perioperative management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative infectious complications	The primary outcome was the incidence of postoperative infectious complications, which were defined as bacterial infections within 30 d after surgery. The diagnosis of infectious complications was based on fever (≥38°C), elevation of C-reactive protein (CRP), specific clinical symptoms of infection, and positive bacterial culture.	up tp 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival		3 years
postoperative recovery parameter	time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay;	up tp 30 days after surgery
blood test result	CAR (C-reactive protein-albumin ratio), LMR (lymphocyte-to-monocyte ratio), NLR (neutrophil-to-lymphocyte ratio), PLR (platelet-to-lymphocyte ratio), SII (systemic immune-inflammation index), PNI (prognostic nutrition index), prealbumin and albumin on pre- and postoperative day (POD) 1, 3 and 5 were detected dynamically	Postoperative, on postoperative day 1, 3 and 5
3-years recurrence-free survival		3 years

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: ERASforNACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No