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Prospective randomized controlled trial of laparoscopic D2 radical gastrectomy and open surgery for advanced gastric cancer

Prospective randomized controlled trial of laparoscopic D2 radical gastrectomy and open surgery for advanced gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001340
Enrollment
Unknown
Registered
2011-04-17
Start date
2011-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

advanced gastric cancer

Interventions

A:Traditional open surgery

Sponsors

Union Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma; 2. Primary tumor resectable; 3. With gastric cancer that can be treated with radical resection: cTNM II-III A defined in 7th edition UICC / AJCC; 4. Age between 18 and 75 Years old, male or female, life expectancy >=12 weeks, BMI <=30 kg/m2 (medium or slim body), without other severe diseases; 5. WHO performance status <2; 6. Informed consent obtained from patients or their appointed agent.

Exclusion criteria

Exclusion criteria: 1. Patients with other gastric malignant diseases, such as lymphoma and stromal tumors, etc.; 2. Patients suffering from malignant diseases before the study; 3. With other severe comorbidities and cannot tolerate laopen surgery can not tolerate laparoscopic surgery or open surgery: such as severe heart and lung diseases, heart function below clinical stage 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc; 4. Patients with previous history of upper abdominal surgery; 5. Patient undergo emergency surgery due to bleeding or perforation of gastric cancer; 6. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation.

Design outcomes

Primary

MeasureTime frame
Postoperative pain;3 and 5-year survival rate;Quality of Life;Compliance rate of lymph node dissection;Operative mortality;Negative rate of tumor margins, The length of cut-s;Complications;Operation time;Intestinal recovery exhaust time;The number of lymph node dissection;Postoperative stress;Immune response;Blood loss;

Countries

China

Contacts

Public ContactChangming HUANG
hcmlr2002@163.com+86 13805069676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026