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Gastric Cancer. 2016 Oct 7. [Epub ahead of print]

Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912.

Author information

  • 1Gastric Surgery Division, National Cancer Center Hospital, 5-1-1 Tsukiji, chuo-ku, Tokyo, 104-0045, Japan. hkatai@ncc.go.jp.
  • 2Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center, Tokyo, Japan.
  • 3Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.
  • 4Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.
  • 5Gastric Surgery Division, National Cancer Center Hospital, 5-1-1 Tsukiji, chuo-ku, Tokyo, 104-0045, Japan.
  • 6Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.
  • 7Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
  • 8Department of Surgery, National Hospital Organization, Sendai Medical Center, Sendai, Japan.
  • 9Department of Surgery, Iwate Medical University, Morioka, Japan.
  • 10Department of Gastroenterological Surgery, Cancer Institute Hospital, Tokyo, Japan.
  • 11Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.
  • 12Department of Gastroenterological Surgery, Hyogo Cancer Center, Akashi, Japan.
  • 13Department of Gastroenterological Surgery, Tenri Hospital, Tenri, Japan.
  • 14Department of Gastroenterological Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
  • 15Division of Upper Gastrointestinal Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.

Abstract

BACKGROUNDS:

No confirmatory randomized controlled trials (RCTs) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG). We performed an RCT to confirm that LADG is not inferior to ODG in efficacy.

METHODS:

We conducted a multi-institutional RCT. Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to ODG or LADG. This study is now in the follow-up stage. The primary endpoint is relapse-free survival (RFS) and the primary analysis is planned in 2018. Here, we compared the surgical outcomes of the two groups. This trial was registered at the UMIN Clinical Trials Registry as UMIN000003319.

RESULTS:

Between March 2010 and November 2013, 921 patients (LADG 462, ODG 459) were enrolled from 33 institutions. Operative time was longer in LADG than in ODG (median 278 vs. 194 min, p < 0.001), while blood loss was smaller (median 38 vs. 115 ml, p < 0.001). There was no difference in the overall proportion with in-hospital grade 3-4 surgical complications (3.3 %: LADG, 3.7 %: ODG). The proportion of patients with elevated serum AST/ALT was higher in LADG than in ODG (16.4 vs. 5.3 %, p < 0.001). There was no operation-related death in either arm.

CONCLUSIONS:

This trial confirmed that LADG was as safe as ODG in terms of adverse events and short-term clinical outcomes. LADG may be an alternative procedure in clinical IA/IB gastric cancer if the noninferiority of LADG in terms of RFS is confirmed.

KEYWORDS:

Clinical trial; Gastrectomy; Gastric cancer; Laparoscopic surgery; Phase III

PMID:
27718137
DOI:
10.1007/s10120-016-0646-9
[PubMed - as supplied by publisher]
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