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

Last updated: December 16, 2025
Sponsor: Zuoyi Jiao
Overall Status: Active - Recruiting

Phase

3

Condition

Gastric Ulcers

Stomach Cancer

Adverse Effects, Drugs

Treatment

ERAS-tube group

ERAS-tubeless group

Clinical Study ID

NCT07029269
LanzhouU2H-2025A-540
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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;

  3. 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;

  4. 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

Study Design

Total Participants: 454
Treatment Group(s): 2
Primary Treatment: ERAS-tube group
Phase: 3
Study Start date:
June 16, 2025
Estimated Completion Date:
September 10, 2028

Connect with a study center

  • International Hospital of Pecking University

    Beijing, Beijing 102206
    China

    Site Not Available

  • International Hospital of Pecking University

    Beijing 1816670, Beijing Municipality 2038349 102206
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Active - Recruiting

  • Lanzhou University Second Hospital

    LanZhou, Gansu 730000
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center Gansu Hospital

    LanZhou, Gansu 730000
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou 1804430, Gansu 1810676 730000
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center Gansu Hospital

    Lanzhou 1804430, Gansu 1810676 730000
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Zhejiang, Hangzhou 310005
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Zhejiang 9898779, Hangzhou 310005
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Xi'an City 710061
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an 1790630, Xi'an City 710061
    China

    Active - Recruiting

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