Safety and feasibility of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: a multicenter phase II trial (JCOG 0703).
BACKGROUND
Although the number of patients undergoing laparoscopy-assisted distal gastrectomy (LADG) has been increasing, a prospective study with a sample size sufficient to investigate the benefit of LADG has never been reported. We conducted a multi-institutional phase II trial to evaluate the safety of LADG with nodal dissection for clinical stage I gastric cancer patients.


METHODS
The subjects comprised patients with clinical stage I gastric cancer who were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic node dissection was performed. The primary endpoint was the proportion of patients who developed either anastomotic leakage or a pancreatic fistula. The secondary endpoints included surgical morbidity and short-term clinical outcome.


RESULTS
Between November 2007 and September 2008, 176 eligible patients were enrolled. The proportion of patients who developed anastomotic leakage or a pancreatic fistula was 1.7%. The overall proportion of in-hospital grade 3 or 4 adverse events was 5.1%. The short-term clinical outcomes were as follows: 43.2% of the patients requested an analgesic on postoperative days 5-10; the median time from surgery until the first episode of flatus was 2 days; and 88 patients (50.0%) had a body temperature of 38 °C or higher during their hospital stay.


CONCLUSIONS
This trial confirmed the safety of LADG performed by credentialed surgeons in terms of the incidence of anastomotic leakage or pancreatic fistula formation. A phase III trial (JCOG 0912) to confirm the noninferiority of LADG to an open gastrectomy in terms of overall survival is ongoing.
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Hitoshi
H
Katai
Mitsuru
M
Sasako
Haruhiko
H
Fukuda
Kenichi
K
Nakamura
Naoki
N
Hiki
Makoto
M
Saka
Hiroki
H
Yamaue
Takaki
T
Yoshikawa
Kazuyuki
K
Kojima
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057868:Anastomotic Leak / Q000453:epidemiology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D008197:Lymph Node Excision / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010185:Pancreatic Fistula / Q000453:epidemiology; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome; D055815:Young Adult