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Table 1 Eligibility criteria

From: 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

Inclusion criteria

  (1) Pancreatic or periampullary lesions requiring pancreatoduodenectomy

  (2) Planned pancreaticojejunostomy including duct-to-mucosa anastomosis

  (3) Main pancreatic duct diameter ≤ 3 mm on the left side of the portal vein on preoperative imaging (computed tomography or magnetic resonance imaging)

  (4) Performance status (Eastern Cooperative Oncology Group scale): 0–1 at the time of enrolment

  (5) Age 20 years or older

  (6) Adequate organ function

  (a) Leukocyte count ≥ 2500 mm3, ≤ 14000 mm3

  (b) Haemoglobin ≥ 9.0 g/dl

  (c) Platelet count ≥ 100,000 mm3

  (d) Total bilirubin ≤ 2.0 mg/dl (does not apply to patients with obstructive jaundice)

  (e) Creatinine ≤ 2.0 mg/dl

  (7) Ability to understand and willingness to sign written informed consent document

Exclusion criteria

  (1) Planned pancreatogastrostomy

  (2) Laparoscopic or laparoscope-assisted pancreatoduodenectomy

  (3) Pancreatic parenchymal atrophy or calcification due to chronic pancreatitis

  (4) Neoadjuvant treatment including chemotherapy or radiotherapy

  (5) History of upper abdominal surgery (both of open and laparoscopic) except cholecystectomy

  (6) Emergency surgery

  (7) Arterial reconstruction such as superior mesenteric artery, common hepatic artery or celiac artery

  (8) Severe ischaemic heart disease

  (9) Severe liver dysfunction due to liver cirrhosis or active hepatitis

  (10) Severe respiratory disorder requiring oxygen

  (11) Chronic renal failure with dialysis

  (12) Requiring resection of other organs (liver or colon) during pancreatoduodenectomy

  (13) Immunosuppressive treatment

  (14) History of severe hypersensitivity to polyglycolic acid felt or fibrin glue

  (15) Other severe drug allergies

  (16) Contrast media allergy for both iodine and gadolinium

  (17) Active duplicate cancer thought to affect adverse events

  (18) Severe psychological or neurological disease

  (19) Drug or alcohol abuse

  (20) Planned use of octreotide