A Multicenter Randomized Phase II Trial Investigating the Effect of Polyglycolic Acid Sheet on the Prevention of Pancreatic Fistula After Gastrectomy with Prophylactic Lymph Node Dissection

Abstract

Dai Shimizu,1 Chie Tanaka,1 Mitsuro Kanda,1 Koki Nakanishi,1 Seiji Ito,2 Yachiyo Kuwatsuka,3 Masahiko Ando,3 Kenta Murotani,4 Michitaka Fujiwara,5 Yasuhiro Kodera1 1Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan; 2Department of Gastroenterological Surgery, Aichi Cancer Center, Nagoya, Japan; 3Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan; 4Biostatistics Center, Graduate School of Medicine, Kurume University, Kurume, Japan; 5Department of Medical Equipment and Supplies Management, Nagoya University Hospital, Nagoya, JapanCorrespondence: Dai Shimizu, Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan, Tel +81-52-744-2249, Fax +81-52-744-2255, Email [email protected]: Pancreatic fistula after gastrectomy with lymph node dissection is associated with prolonged hospital stay and critical complications such as intra-abdominal bleeding and sepsis. Polyglycolic acid (PGA) sheets are absorbable suture reinforcement materials. A randomized Phase II trial has been planned to evaluate the effect of PGA sheets on preventing postoperative pancreatic fistula. A total of 320 patients will be recruited from thirteen institutions. Patients who are scheduled to undergo distal or total gastrectomy will be randomly allocated into the PGA group or control group, and the dissected area around the pancreas will be covered by the PGA sheet in the PGA group. The primary endpoint will be the maximum value of drain amylase concentration up to 5 days after surgery. The secondary endpoints will be as follows: transition of value of amylases of drain discharge, incidence of pancreatic fistula, incidence of intra-abdominal abscess, white blood cell count, value of C-reactive protein, incidence of postoperative complication, duration of antibiotic agents administration, duration of abdominal drainage, usage of octreotide, duration of hospital stay, incidence of bleeding in abdominal cavity, mortality, and incidence of reoperation.Keywords: gastric cancer, pancreatic fistula, polyglycolic acid sheet, protocol, randomized clinical tria