Clinical trial · Interventional
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
NCT06489288CI-TRIAL-00078567unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ERAS | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Laparoscopic Gastrectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ERAS group
- description
- 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
- interventionNames
- Other: ERAS protocol
- type
- OTHER
- label
- control group
- description
- According to conventional treatment measures, there is no need for Enhanced Recovery After Surgery
- interventionNames
- Other: ERAS protocol
Primary outcomes (4)
- measure
- QLQ-STO22
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.