Enhanced recovery after laparoscopic distal gastrectomy without routine abdominal drainage tubes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: jiaozy@lzu.edu.cn
• Phone: +86-0931-5190920

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 68Ga-YQ-CC05: a new probe for detecting tumors with CCK2R

  This study tests a radioactive probe called 68Ga-YQ-CC05 to see if it can safely help find tumors in adults with certain cancers using PET-CT imaging.

  Recruiting Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu · NCT07914764

• Neoadjuvant immunotherapy plus Nab-P-SOX for locally advanced gastric/GEJ cancer

  This phase 2, single-arm study tests a pre-surgery treatment that combines a PD-1/CTLA-4 bispecific antibody with nab-paclitaxel, oxaliplatin, and S-1 in adults with HER2-negative, locally advanced gastric or GEJ cancer.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07867392

• Maintenance therapy in metastatic gastric cancer: a multicenter look from Colombia

  This study reviews medical records of adults with metastatic gastric cancer in Colombia to see how patients fare after starting maintenance therapy following initial chemotherapy.

  Recruiting at 4 sites Fundación Santa Fe de Bogota · Bogotá, Bogota D.C. and 3 other locations · NCT07856212

• AI-powered tumor response assessment after preoperative treatment in stomach and gastroesophageal junction cancer

  Researchers are testing whether an AI tool called DeepTRG can reliably measure how much cancer remains in tissue removed after preoperative therapy in stomach and GEJ cancer, without needing a human to correct the AI results.

  Recruiting Hebei Medical University · Shijiazhuang, None Selected · NCT07849608

• Image-guided platform helps find sentinel lymph nodes in early gastric cancer

  This study tests whether an image-guided platform with a deep learning model can find and retrieve sentinel lymph nodes better than standard palpation in people with early gastric cancer undergoing LECS-SNNS.

  Recruiting Beijing Friendship Hospital · Beijing · NCT07835087

• Breath test to help detect gastrointestinal cancers early

  A breath test that looks for signals in exhaled air to see if someone with gut cancer symptoms might have oesophageal, stomach, pancreatic, liver, or colorectal cancer and need urgent testing.

  Recruiting Imperial College London · Maidstone, Kent and 5 other locations · NCT07714538

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.