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)

• Published in: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association Vol. 13; no. 4; pp. 238 - 244
• Main Authors: Katai, Hitoshi, Sasako, Mitsuru, Fukuda, Haruhiko, Nakamura, Kenichi, Hiki, Naoki, Saka, Makoto, Yamaue, Hiroki, Yoshikawa, Takaki, Kojima, Kazuyuki
• Format: Journal Article
• Language: English
• Published: Japan Japan : Springer Japan 01.11.2010; Springer Japan; Springer Nature B.V
• Subjects: Abdominal Surgery; Adult; Aged; Aged, 80 and over; Anastomotic Leak - epidemiology; Cancer Research; Feasibility Studies; Female; Follow-Up Studies; Gastrectomy - adverse effects; Gastrectomy - methods; Gastric cancer; Gastroenterology; Humans; Laparoscopy - adverse effects; Laparoscopy-assisted distal gastrectomy; Lymph Node Excision - methods; Male; Medicine; Medicine & Public Health; Middle Aged; morbidity; Oncology; Original Article; Pancreatic Fistula - epidemiology; stomach neoplasms; Stomach Neoplasms - pathology; Stomach Neoplasms - surgery; Surgical Oncology; Treatment Outcome; Young Adult; Gastric cancer; Morbidity; Laparoscopy-assisted distal gastrectomy
• ISSN: 1436-3291; 1436-3305; 1436-3305
• DOI: 10.1007/s10120-010-0565-0

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.