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Clinical efficacy of three hole total laparoscopic radical gastrectomy for distal gastric cancer: a multicenter, prospective, randomized controlled study

Clinical efficacy of three hole total laparoscopic radical gastrectomy for distal gastric cancer: a multicenter, prospective, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060322
Enrollment
Unknown
Registered
2022-05-28
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Experimental group:Three hole laparoscopic surgery
Control group:Five hole laparoscopic surgery

Sponsors

The First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The operator can complete radical D2 lymph node dissection (the number of lymph nodes checked must reach at least 15 to ensure the quality of the operation); 2. Physical condition and visceral function allow for major abdominal surgery; 3. Willing to and able to abide by the protocol during the study period, provide written informed consent before entering the study screening, and the patient has understood that he can withdraw from the study at any time without any loss; 4. Aged 18-75 years old, gastric adenocarcinoma confirmed by preoperative pathology and the tumor is located in the middle and lower part of the gastric body, laparoscopic D2 distal gastrectomy is planned; 5. Expected survival time > 6 months, without other serious concomitant diseases and with good organ function; 6. BMI 60; ECOG score: 0-2; 16. Postoperative patients can receive chemotherapy according to CSCO guidelines.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women, who are in the childbearing period and have not taken effective contraceptive measures; 2. Combining serious medical diseases or conditions: such as clinically serious (ie, active) heart disease, serious, uncontrolled medical diseases and infections, severe uncontrolled digestive disorders, severe electrolyte disorders, active dissemination intravascular coagulation, major organ failure, such as decompensated heart, lung, liver, kidney failure, symptoms of peripheral neuropathy, etc., can not tolerate D2 radical gastrectomy; 3. Organ transplantation requires immunosuppressive therapy; 4. Severe uncontrolled recurrent infection, or other serious uncontrolled accompanying diseases; 5. History of other malignant tumors within 5 years after the start of the trial, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 6. Patients without self-awareness and mental disorders; 7. Have a history of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); 8. Taking other experimental drugs at the same time or being in other clinical trials; 9. Those who have received biological therapy or other anti-cancer traditional Chinese medicine with an interval of less than 4 weeks; 10. During the operation, the surgeon thinks that the three-hole total laparoscopic radical gastrectomy for distal gastrectomy cannot be completed or other surgical methods need to be changed; 11. Cannot receive chemotherapy after surgery; 12. The general type of tumor is Borrmann type IV; 13. Tumor recurrently invades surrounding organs (T4b) or combined with distant metastasis; 14. Combined organ resection is required during the operation.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Progression free surviva;Operation time;

Countries

China

Contacts

Public ContactJi Gang

The First Affiliated Hospital of Air Force Military Medical University

Inte1385@163.com+86 15389058362

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026