ERAS for Gastric Cancer Patients After NACT

NCT06365814 | Completed DMC

• 1 other identifier: ERASforNACT
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• postoperative recovery parameter

  up tp 30 days after surgery

• blood test result

  Postoperative, on postoperative day 1, 3 and 5

• 3-year overall survival

  3 years

• 3-years recurrence-free survival

  3 years

Study Arms (2)

ERAS group

Other: enhanced recovery after surgery

Conventional group

Other: conventional perioperative management

Interventions

enhanced recovery after surgery OTHER

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

ERAS group

conventional perioperative management OTHER

conventional perioperative management

Conventional group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (1)