Trial Title:
ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer
NCT ID:
NCT06489288
Condition:
Gastric Cancer
ERAS
Laparoscopic Gastrectomy
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer
ERAS
Totally laparoscopic total gastrectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
ERAS protocol
Description:
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
Arm group label:
ERAS group
Arm group label:
control group
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xijing Hospital of Digestive Diseases
Address:
City:
Xi'an
Zip:
710000
Country:
China
Start date:
May 1, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
General Hospital of Ningxia Medical University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Suzhou University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Gansu Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Changzhi People's Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Shandong First Medical University
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06489288
