Enhanced recovery after laparoscopic distal gastrectomy without routine abdominal drainage tubes

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

This trial will test whether skipping routine abdominal drainage tubes during enhanced recovery after laparoscopic distal gastrectomy helps adults (18–80) with gastric adenocarcinoma recover as well as using drains.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Lanzhou University Second Hospital (Academic / other)
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT07029269 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized non-inferiority Phase 3 trial comparing two perioperative ERAS approaches for patients undergoing laparoscopic distal gastrectomy for gastric adenocarcinoma. Participants are randomized 1:1 to an ERAS protocol without routine abdominal drains (tubeless) or to an ERAS protocol with prophylactic abdominal drainage tubes, with neither group receiving nasogastric decompression or nasojejunal feeding. The primary analysis uses a modified intention-to-treat population and secondary analyses use a per-protocol population. Postoperative management follows ERAS guidelines and patient-reported outcomes are measured with EORTC QLQ-C30 and QoR-15 questionnaires.

Who should consider this trial

Good fit: Adults aged 18–80 with histologically confirmed gastric adenocarcinoma staged cT1-4N0-3M0, planned for laparoscopic distal gastrectomy and with ECOG 0–1 who can provide informed consent are ideal candidates.

Not a fit: Patients with severe comorbidities, uncontrolled diabetes, prior radiotherapy, metastatic disease, emergency surgery, extreme BMI (<18 or ≥30 kg/m2), or other exclusion conditions are unlikely to benefit from the tubeless approach in this protocol.

Why it matters

Potential benefit: If successful, this approach could shorten recovery, reduce discomfort and device-related complications, and improve postoperative quality of life by eliminating routine abdominal drains.

How similar studies have performed: ERAS protocols and selective omission of drains have shown promising results in other abdominal surgeries, but randomized evidence specifically for tubeless laparoscopic distal gastrectomy is limited.

Eligibility criteria

Inclusion Criteria:

1. Patients' age from 18 to 80 years old;
2. Histopathologically confirmed gastric adenocarcinoma;
3. Clinical tumor stage of cT1-4N0-3M0;
4. Laparoscopic distal gastrectomy approach;
5. ECOG score of 0-1;
6. Written informed consent

Exclusion Criteria:

1. Patients with severe concurrent illness or comorbid diseases;
2. 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

Where this trial is running

Beijing, Beijing Municipality and 5 other locations

• International Hospital of Pecking University — Beijing, Beijing Municipality, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• Lanzhou University Second Hospital — Lanzhou, Gansu, China (Recruiting)
• Sun Yat-sen University Cancer Center Gansu Hospital — Lanzhou, Gansu, China (Recruiting)
• Zhejiang Cancer Hospital — Zhejiang, Hangzhou, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Xi'an City, China (Recruiting)

Study contacts

• Study coordinator: Zuoyi Jiao, M.D.

Conditions Gastric Adenocarcinoma; Laparoscopic Gastrectomy; Complications; Enhanced Recovery After Surgery; tubeless; gastric adenocarcinoma; laparoscopic distal gastrectomy