NCT01456598

Efficacy of Laparoscopic Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer

Prospective Multicenter Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,050 (actual)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

* It was confirmed that the laparoscopic surgery decreases the postoperative pain and reduces the recovery periods in the various surgical fields such as cholecystectomy and colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is applicable to malignant tumor according to the development of surgical techniques and medical instruments. * In case of early stage of gastric cancer, as the diverse clinical evidences, the gastrectomy has been commonly applied, however, the opening surgery is still applied for advanced gastric cancer due to lack of clinical evidence. * In Korea, approximately 38% of patients who undergo surgery for gastric cancer are diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer registration business in 2009). There are various clinical evidences to apply laparoscopic surgery to the patients, however, most of them are retrospective or cohort study results. * For the clinical application of surgical treatment regarding locally advanced gastric cancer using laparoscopic surgical technique, it requires the confirmation of definite execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of surgery and oncological usefulness should be verified. * In order for this, it is only possible to confirm through the comparison of short-term surgical results (complications, mortalities, operative time and duration of hospitalization etc) and long-term results (survival rates and recurrence rates etc) between laparoscopic surgery and opening surgery based on the multicenter large-sized randomized prospective study with current standard treatment.

Detailed description

Participating Surgeons * Prior to this clinical trial, only the surgeons who are considered to have the standardization by participating the assignment entitled with "KLASS-02-QC: Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial"(ClinicalTrials.gov No: NCT01283893). Patients Registration * It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms. * After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Ajou University clinical trial center. Randomization * The registration randomization should be done with 1:1 ratio for each researcher. * Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table. Procedure * Operations are performed according to the allocated group. Adjuvant Treatment * If it is under Stage II and Stage III in the final postoperative pathology, the adjuvant chemotherapy based on 5-FU. Evaluation of efficacy and safety * 3-year Relapse free survival rate and overall survival rate of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection. * Analysis of recovery after laparoscopic and open subtotal gastrectomy and D2 lymph node dissection. * Postoperative complications of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection within postoperative 3 weeks and later. * The quality of life at preoperative, postoperative 25 days and 1 years using recovery index such as recovery of postoperative intestinal hypermotility, meals and duration of hospitalization, EORTC-C30 and STO22 questionnaire between the patients who underwent laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic gastrectomy	* After laparoscopic observation, the possibility of surgery can be considered by examining inside of abdomen. * The surgeon undergoes laparoscopic subtotal gastrectomy and D2 lymph node dissection * After lymph node dissection, it is possible to undergo gastrectomy on appropriate part and reconstruction under small incision or laparoscopic view. * As the reconstruction, one of the techniques like Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.
PROCEDURE	Open gastrectomy	* After laparotomy, the possibility of surgery can be considered by examining inside of abdomen. * The surgeon undergoes open subtotal gastrectomy and D2 lymph node dissection * After lymph node dissection, one of the techniques likes Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.

Timeline

• Start date: 2011-11-21
• Primary completion: 2018-06-02
• Completion: 2018-06-02
• First posted: 2011-10-21
• Last updated: 2018-11-29

Locations

13 sites across 1 country: South Korea