BACKGROUND: The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection for locally advanced @entity356 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 @entity356 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. @entity1 aged 20-80  years were pre-operatively randomized. RESULTS: In total, 180 @entity1 were registered and randomized to the open (89 @entity1 ) and laparoscopic arms (91 @entity1 ). Among 91 @entity1 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 @entity1 with either @entity834 or pancreatic @entity292 was 4.7  % (4/86). The grade 3 or higher morbidity rate, including @entity149 , was 5.8  %. Conversion to open surgery was required for 1 @entity1 (1.2  %), without any @entity532 . The post-operative mortality rate was 0, and no @entity1 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 @entity356 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/ ).

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

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity834 :: ('MESH:D057868', 'Disease') :: ['anastomotic leakage'] @entity149 :: ('MESH:D002493', 'Disease') :: ['systemic and local complications'] @entity532 :: ('MESH:D003925', 'Disease') :: ['intra-operative complication'] @entity292 :: ('MESH:D005402', 'Disease') :: ['fistula'] @entity356 :: ('MESH:D013274', 'Disease') :: ['gastric cancer']
@entity356 :: (MESH:D013274,Disease) :: ['Gastric Cancer']
