Clinical trial NCT06489288: ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer
Official title: The Safety and Efficacy of ERAS Clinical Pathway Intotally Laparoscopic Total Gastrectomy: a Multicenter, Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastric Cancer
ERAS
Laparoscopic Gastrectomy
Keywords: Gastric Cancer
ERAS
Totally laparoscopic total gastrectomy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
name: First Affiliated Hospital of Wenzhou Medical University
name: Peking University Cancer Hospital & Institute
name: Tongji Hospital
name: General Hospital of Ningxia Medical University
name: Second Affiliated Hospital of Suzhou University
name: The First Affiliated Hospital with Nanjing Medical University
name: Nanfang Hospital, Southern Medical University
name: Gansu Provincial Hospital
name: Fudan University
name: Changzhi People's Hospital
name: Zhejiang University
name: First Affiliated Hospital Xi'an Jiaotong University
name: First Affiliated Hospital, Sun Yat-Sen University
name: The Second Affiliated Hospital of Shandong First Medical University
name: Guangdong Provincial People's Hospital
First posted: 2024-07-05
Enrollment: 2656
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 \&lt;1.5 times the upper limit of normal; serum creatinine \&lt;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 \&gt; 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)

Primary outcomes:
measure: QLQ-STO22
timeFrame: Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
measure: QLQ-C30 (V3.0)
timeFrame: Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery
measure: Complication rate
timeFrame: 1month
measure: DFS
timeFrame: 1 and 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References: