NCT07029269RecruitingPhase 3
Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer
Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer: A Prospective, Multicenter, Non-inferiority, Randomized, Open-label, Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
This study aims to compare the effects of using prophylactic abdominal drainage tubes during Enhanced Recovery After Surgery (ERAS) in patients undergoing Laparoscopic Distal Gastrectomy (LDG) for gastric cancer through a multicenter non-inferiority randomized trial. The study is divided into two groups: 1. ERAS-tubeless group: The ERAS protocol without nasogastric decompression, nasojejunal feeding or prophylactic abdominal drainage tubes. 2. ERAS-tube group: the ERAS protocol with prophylactic abdominal drainage tubes, along with no nasogastric decompression or nasojejunal feeding tubes. Patients will be randomly assigned to the two groups in a 1:1 ratio, with the primary analysis based on the modified intention-to-treat population (mITT) and secondary analysis on the per-protocol (PP) population. Perioperative management will adhere to ERAS guidelines, and postoperative quality of life will be assessed using the EORTC QLQ-C30 questionnaire and QoR-15 scores. Preliminary training on the standard ERAS protocol is administered to all members in the team before the initiation of the study, ensuring in-group members to fully master the requirements and other related contents in the study. Data collectors, analysts, and outcome evaluators will remain blinded to group allocation. The findings of this study are expected to provide high-quality evidence on the feasibility of omitting prophylactic abdominal drainage in the context of ERAS, thereby contributing to the optimization of postoperative management strategies for gastric cancer surgery.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 454 (estimated)
- First submitted
- 24 May 2025
- Start date
- 16 Jun 2025
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Zuoyi Jiao
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07029269
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 454
- From 16 Jun 2025 to the primary completion date, 1 Jun 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe concurrent illness or comorbid diseases;
Lab values
- Patients with severe pyloric obstruction, recurrent or remnant gastric cancer; 3. Patients with perforation, or undergoing emergency surgery;
- 4\. Patients with a history of radiotherapy; 5. Patients undergoing complex abdominal surgeries other than laparoscopic cholecystectomy or appendectomy; 6. Patients with peritoneal, hepatic or ovarian metastasis, or simultaneous tumors in other parts of the body preoperatively and intraoperatively; 7. Patients with diabetes and poor recent glycemic control; 8. Patients with autoimmune diseases who have received corticosteroid treatment; 9. Patients with a BMI ≥30 kg/m2 or \<18 kg/m2; 10. Patients with gastrointestinal hemorrhage and hemoglobin levels below 90 g/L; 11. Patients with hypoproteinemia and albumin levels below 30 g/L; 12. Patients with portal hypertension; 13. Patients with severe edema or dense fibrosis intraoperatively after neoadjuvant therapy; 14. Patients with intraoperative findings of duodenal invasion; 15. Patients with combined organ resection; 16. Reconstruction different from BillrothⅡand Braun anastomosis; 17. Patients with preoperative pathological examination inconsistent with postoperative result; 18. Declined to participate; 19. Patients with poor compliance and withdrew from the study halfway
Who the study is looking for
- Patients' age from 18 to 80 years old;
- Histopathologically confirmed gastric adenocarcinoma;
- Clinical tumor stage of cT1-4N0-3M0;
- Laparoscopic distal gastrectomy approach;
- ECOG score of 0-1;
- Written informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| International Hospital of Pecking University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| Sun Yat-sen University Cancer Center Gansu Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Zhejiang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.