ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer

NCT ID: NCT06489288

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

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.

Conditions

Gastric Cancer; ERAS; Laparoscopic Gastrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

ERAS protocol

Intervention Type: OTHER

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

control group

According to conventional treatment measures, there is no need for Enhanced Recovery After Surgery

Group Type: OTHER

ERAS protocol

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Suzhou University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Gansu Provincial Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Changzhi People's Hospital

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Shandong First Medical University

OTHER

Sponsor Role: collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

CLASS12

Identifier Type: -

Identifier Source: org_study_id