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01.11.2015 | Original Scientific Report | Ausgabe 11/2015

World Journal of Surgery 11/2015

A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901)

Zeitschrift:
World Journal of Surgery > Ausgabe 11/2015
Autoren:
Noriyuki Inaki, Tsuyoshi Etoh, Tetsuji Ohyama, Kazuhisa Uchiyama, Natsuya Katada, Keisuke Koeda, Kazuhiro Yoshida, Akinori Takagane, Kazuyuki Kojima, Shinichi Sakuramoto, Norio Shiraishi, Seigo Kitano
Wichtige Hinweise
On behalf of the Japanese Laparoscopic Surgery Study Group.

Abstract

Background

The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection for locally advanced gastric cancer remain unclear. Therefore, we conducted a randomized, controlled phase II trial to confirm the feasibility of LADG in terms of technical safety, and short-term surgical outcomes were investigated.

Methods

Eligibility criteria included pre-operatively diagnosed advanced gastric cancer that could be treated by distal gastrectomy with D2 lymph node dissection; MP, SS, and SE without involvement of other organs; and N0–2 and M0. Patients aged 20–80 years were pre-operatively randomized.

Results

In total, 180 patients were registered and randomized to the open (89 patients) and laparoscopic arms (91 patients). Among 91 patients in the laparoscopic arm, 86 underwent laparoscopic gastrectomy according to the study protocol. Regarding the primary endpoint of the phase II trial, the proportion of patients with either anastomotic leakage or pancreatic fistula was 4.7 % (4/86). The grade 3 or higher morbidity rate, including systemic and local complications, was 5.8 %. Conversion to open surgery was required for 1 patient (1.2 %), without any intra-operative complication. The post-operative mortality rate was 0, and no patient required readmission for surgical complications within 6 months after initial discharge.

Conclusions

The technical safety of LADG with D2 lymph node dissection for locally advanced gastric cancer was demonstrated. A phase III trial to confirm the non-inferiority of this procedure to open gastrectomy in terms of long-term outcomes is ongoing. Registered Number: UMIN 000003420 (www.​umin.​ac.​jp/​ctr/​).

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