Status:
ACTIVE_NOT_RECRUITING
ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
First Hospital of China Medical University
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Gastric Cancer
ERAS
Eligibility:
All Genders
18-80 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- 18-80 years;
- ASA I-III;
- ECOG ≤2;
- NRS2002: 0-2;
- Preoperative gastroscopy and pathological biopsy confirmed adenocarcinoma;
- 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);
- Proposed D2 total laparoscopic radical gastrectomy (without limitation on the anastomotic method);
- All patients did not receive adjuvant radiotherapy, chemotherapy, or other cytotoxic treatments before surgery;
- Borrmann I-III ;
- No history of upper abdominal surgery (except for laparoscopic cholecystectomy); no history of peritonitis or pancreatitis
- 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
- tumors at the esophagogastric junction or gastric tumors that have invaded the pyloric canal;
- Those with uncontrolled epilepsy, central nervous system diseases, or a history of mental disorders;
- 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;
- Patients with urinary dysfunction who require long-term indwelling catheters after surgery;
- Patients who need immunosuppressive therapy for organ transplantation;
- Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases;
- 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);
- Emergency surgery due to tumor emergencies (bleeding, perforation, obstruction);
- Pregnant or breastfeeding women;
- Previously diagnosed other tumors (excluding cervical cancer and cutaneous melanoma)
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
2656 Patients enrolled
Trial Details
Trial ID
NCT06489288
Start Date
May 1 2024
End Date
December 1 2025
Last Update
July 5 2024
Active Locations (1)
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1
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710000