The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3 mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea

Abstract

Background Partial pancreatoduodenectomy is performed for malignant and benign diseases of the pancreatic head region. The procedure is considered highly difficult and highly invasive. Postoperative pancreatic fistula (POPF) is an important complication because of several consequent complications, including intraabdominal haemorrhage, often increasing hospital stays and surgical mortality. Although many kinds of pancreaticojejunostomy aimed at reducing POPF have been examined to date, the technique has not yet been standardized. We devised a new method using double-coated polyglycolic acid felt after pancreaticojejunostomy. The aim of the PLANET-PJ trial is to evaluate the superiority of polyglycolic acid felt reinforcement in preventing POPF after pancreaticojejunostomy in patients undergoing partial pancreatoduodenectomy to previous anastomosis methods. Methods Patients diagnosed with pancreatic or periampullary lesions in whom it is judged that the main pancreatic duct diameter was 3 mm or less on the left side of the portal vein without pancreatic parenchymal atrophy due to obstructive pancreatitis are considered eligible for inclusion. This study is designed as a multicentre randomized phase III trial in Japan and the Republic of Korea. Eligible patients will be centrally randomized to either group A (polyglycolic acid felt reinforcement) or group B (control). In total, 514 patients will be randomized in 31 high-volume centres in Japan and Republic of Korea. The primary endpoint is the incidence of POPF (International Study Group of Pancreatic Surgery grade B/C). Discussion The PLANET-PJ trial evaluates the efficacy of a new method using double-coated polyglycolic acid felt reinforcement for preventing POPF after pancreaticojejunostomy. This new method may reduce POPF. Trial registration ClinicalTrials.gov, NCT03331718 . University Hospital Medical Information Network Clinical Trials Registry, UMIN000029647. Registered on 30 November 2017. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033874 Electronic supplementary material The online version of this article (10.1186/s13063-019-3595-x) contains supplementary material, which is available to authorized users.

Effect of a Polyglycolic Acid Mesh Sheet (Neoveil™) in Thyroid Cancer Surgery: A Prospective Randomized Controlled Trial

“…A polyglycolic acid mesh sheet is a tissue-strengthening agent that reduces air or fluid leakage from the surgical site. Many clinical studies have been conducted, and they proved the preventive effect of polyglycolic acid mesh sheets for air, fluid and bowel content leakage [ 9 , 11 , 12 , 13 , 14 , 15 , 16 , 18 ]. However, no study has shown that the polyglycolic acid mesh sheet is effective in thyroid surgery for reducing exudate or chyle leakage.…”

“…A polyglycolic acid mesh sheet (Neoveil™) is a tissue-strengthening repair agent that prevents air or fluid leakage after surgery. The preventive effect of polyglycolic acid mesh sheets has been proven in various surgical fields; these sheets diminish air leakage after lung resection surgery [ 9 , 10 , 11 , 12 ], reduce the pancreatic fistula incidence in pancreas resection [ 13 , 14 , 15 , 16 ], prevent bile leakage and hemorrhage after liver resection [ 17 ], and prevent bowel content leakage after colon surgery [ 18 ]. However, there are no clinical studies on whether polyglycolic acid mesh sheets can reduce exudates from the neck node dissection area and have a protective effect against chyle in thyroid surgery.…”

Comparisons of short-term outcomes of anastomotic methods of duct-to-mucosa pancreaticojejunostomy: out-layer continuous suture versus modified Blumgart method

“…Various modifications of surgical techniques have been applied according to surgeons’ preferences, including the Blumgart method [ 5 7 8 9 10 11 13 14 16 18 20 ]. Although none of them have been found to be superior to another, new attempts to reduce POPF are still ongoing, such as applying polyglycolic acid or fibrinogen/thrombin-coated collagen patch [ 1 2 3 12 22 ].…”

“…There have been attempts to reduce the occurrence of POPF by applying various techniques, but the results are still controversial [ 2 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ]. Pancreaticojejunostomy (PJ), which anastomoses the pancreatic stump to the jejunal loop, was popularized by Whipple in the 1940s [ 25 ].…”

Effect of polyglycolic acid mesh for prevention of pancreatic fistula after pancreatectomy

“…Postoperative pancreatic fistula (POPF) is the most common and intractable complication after partial pancreatectomy, with an incidence of 13% to 64%. [ 1 – 4 ] Although the development of surgical techniques and lots of new experimental attempts in perioperative management has significantly reduced the mortality of pancreatic surgery, [ 5 ] the postoperative complications are still high, reaching 40% to 50%. [ 6 ] Leakage of pancreaticojejunostomy or POPF is the major complication after a pancreatectomy.…”