Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer

Recruiting now · Phase 3

Conditions studied: Gastric Adenocarcinoma, Laparoscopic Gastrectomy, Complications

In brief

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.

Key facts

Study ID: NCT07029269
Run by: Zuoyi Jiao
People needed: 454
Starts: 2025-06-16
Expected to finish: 2028-09-10
Last updated by the study team: 2025-12-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Patients with severe concurrent illness or comorbid diseases;
Patients with severe pyloric obstruction, recurrent or remnant gastric cancer; 3. Patients with perforation, or undergoing emergency surgery;
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 it is running

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

Full record on ClinicalTrials.gov

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