Single-institute prospective trial of laparoscopy-assisted distal gastrectomy with systemic lymph node dissection for early gastric carcinoma.

Background: Laparoscopy-assisted gastrectomy (LAG) is an advanced surgery that requires the mastery of complex surgical skills. We evaluate the feasibility of LAG with systemic lymph node dissection when participating surgeons have sufficient knowledge and experience to conduct open surgery for gastric cancer and basic laparoscopic skills.
Methods: All operations were performed by two Japan Surgical Society board-certified attending surgeons who had performed over 50 conventional gastrectomies and 30 laparoscopic cholecystectomies. The surgeons went through an established program, including training at the wet and dry laboratories. In addition, surgeries for the first 10 cases were assisted by an expert surgeon with experience of >300 cases. To be eligible for the LAG procedure, patients had to have a preoperative diagnosis of T1, N0 and M0 gastric carcinoma. The morbidity rate was used as the study endpoint. Variables such as operating time, intraoperative blood loss and number of retrieved lymph nodes were evaluated as complementary surgical endpoints. These variables were compared between the first 25 cases and the latter 25 cases.
Results: A total of 50 patients who were scheduled to undergo LAG were prospectively enrolled between 2005 and 2008. Morbidity rate was 4% (2/50), with one case due to intestinal injury and one case due to an intra-abdominal abscess. Complications related to laparoscopy were observed in 2% (1/50), with one case of mesenteric injury. The conversion rate to laparotomy was 6% (3/50). However, there were no serious consequences in converted cases. The operating time was 263.7 ± 45.0 min. The intraoperative blood loss was 94.5 ± 106.5 g. The total number of regional lymph nodes retrieved was 34.7 ± 12.2. A significant improvement in the blood loss was only noted after the first 25 procedures. All patients are alive and disease-free after a median follow-up of 38.8 months.
Conclusion: An adequate training program, including site visits by expert surgeons, in conjunction with basic laparoscopy skills and solid backgrounds in open gastrectomy from the perspective of the trainees are currently key to the successful and safe implementation of LAG. Whether the procedure is oncologically feasible remains to be confirmed by long-term follow-up.