ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer

The Safety and Efficacy of ERAS Clinical Pathway Intotally Laparoscopic Total Gastrectomy: a Multicenter, Prospective Randomized Controlled Study

The number of totally laparoscopic total gastrectomy is gradually increasing, but the safety of ERAS in these term is still unknown and further multicenter randomized controlled studies are needed.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer; ERAS; Laparoscopic Gastrectomy
• Intervention / Treatment: Other: ERAS protocol

Detailed Description

The application of ERAS during the perioperative of gastric cancer surgery can reduce hospitalization time, costs, and surgical stress response without increasing complications and readmission rates, and may even have a certain effect on improving long-term survival rates of patients. However, some studies have also shown that ERAS may increase the number of postoperative readmissions while reducing hospitalization time, costs, and recovery time after surgery. At the same time, there is still no consensus on the application standards of ERAS during the perioperative period of gastric cancer surgery , and the comprehensive implementation of ERAS programs in clinical practice still faces huge challenges. With the widespread development of totally laparoscopic total gastrectomy , the advantages of laparoscopy have been recognized. Multiple center studies have confirmed the safety of ERAS programs in totally laparoscopic distal radical gastrectomy. However, due to the complexity of totally laparoscopic total gastrectomy, there is currently no multi-center study to confirm the safety of ERAS in it. In order to better apply ERAS in clinical practice, better serve patients undergoing gastric cancer surgery, and provide more centers with practical experience in ERAS and even provide evidence for the establishment of a consensus on ERAS during the perioperative of gastric cancer surgery, our center will rely on platform advantages and previous work experience and collaborate with the CLASS Research Center to conduct a prospective, multi-center clinical study to explore the safety and effectiveness of ERAS clinical pathway in patients undergoing totally laparoscopic total gastrectomy, providing a theoretical basis for further standardizing and promoting the application of ERAS concept in the perioperative clinical practice of gastric cancer surgery.

• Study Type: Interventional
• Enrollment (Estimated): 2656
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-80 years;
2. ASA I-III;
3. ECOG ≤2;
4. NRS2002: 0-2;
5. Preoperative gastroscopy and pathological biopsy confirmed adenocarcinoma;
6. The clinical stage of abdominal hypotonic enhanced CT or ultrasonic gastroscopy is cT2-3N0-3M0 or cT1N+M0 or cT4aN0M0 (according to the AJCC-8thTNM tumor staging);
7. Proposed D2 total laparoscopic radical gastrectomy (without limitation on the anastomotic method);
8. All patients did not receive adjuvant radiotherapy, chemotherapy, or other cytotoxic treatments before surgery;
9. Borrmann I-III ;
10. No history of upper abdominal surgery (except for laparoscopic cholecystectomy); no history of peritonitis or pancreatitis
11. hemoglobin ≥80g/L; absolute neutrophil count (ANC) ≥1.5×109/L; platelet ≥100×109/L; ALT, AST≤1 times the upper limit of normal; ALP≤1 times the upper limit of normal; total serum bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥35g/L;

Exclusion Criteria:

1. tumors at the esophagogastric junction or gastric tumors that have invaded the pyloric canal;
2. Those with uncontrolled epilepsy, central nervous system diseases, or a history of mental disorders;
3. Severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, or severe drug-dependent arrhythmia, or a history of myocardial infarction within the last 6 months;
4. Patients with urinary dysfunction who require long-term indwelling catheters after surgery;
5. Patients who need immunosuppressive therapy for organ transplantation;
6. Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases;
7. Moderate or severe renal impairment [creatinine clearance equal to or lower than 50ml/min (calculated according to the Cockroft and Gault equation), or serum creatinine > upper limit of normal (ULN);
8. Emergency surgery due to tumor emergencies (bleeding, perforation, obstruction);
9. Pregnant or breastfeeding women;
10. Previously diagnosed other tumors (excluding cervical cancer and cutaneous melanoma)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS group; It is necessary to remove the urinary catheter before the patient awakens from anesthesia, drink water orally in the early postoperative period, and remove the drainage tube and nutrition tube in the early postoperative period	Other: ERAS protocol; The ERAS process mainly includes removing the urethral catheter before the recovery of anesthesia, removing the abdominal drainage tube within 3 days after surgery, removing the nasogastric feeding tu
Other: control group; According to conventional treatment measures, there is no need for Enhanced Recovery After Surgery	Other: ERAS protocol; The ERAS process mainly includes removing the urethral catheter before the recovery of anesthesia, removing the abdominal drainage tube within 3 days after surgery, removing the nasogastric feeding tu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QLQ-STO22	Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery	Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
QLQ-C30 (V3.0)	Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery	Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
Complication rate	Complications rate and Clavien-Dindo classification within 1 month after surgery	1month
DFS	Disease-free survival rate at 1 and 3 years after surgery	1 and 3 years

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Fudan University; First Affiliated Hospital, Sun Yat-Sen University; Tongji Hospital; Peking University Cancer Hospital & Institute; First Affiliated Hospital Xi'an Jiaotong University; Guangdong Provincial People's Hospital; Gansu Provincial Hospital; Zhejiang University; First Hospital of China Medical University; General Hospital of Ningxia Medical University; First Affiliated Hospital of Wenzhou Medical University; Second Affiliated Hospital of Suzhou University; Changzhi People's Hospital; The Second Affiliated Hospital of Shandong First Medical University; Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Gastric Cancer; ERAS; Totally laparoscopic total gastrectomy
• 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: CLASS12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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