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Table 1 Eligibility criteria

From: Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial

Inclusion criteria

Exclusion criteria

(1) Elective open or laparoscopic DP for diseases of the pancreatic body and tail

(2) ECOG performance status (PS) = 0–1

(3) Age ≥ 20 years

(4) Maintenance of function of the major organs (bone marrow, liver, kidney, lung, etc.)

(a) White blood cells ≥ 2500/mm3

(b) Haemoglobin ≥ 9.0 g/dL

(c) Platelets ≥ 100,000/mm3

(d) Total bilirubin ≤ 2.0 mg/dL

(e) Creatinine ≤ 2.0 mg/dL

(5) Sufficient understanding of the study to provide written informed consent

(1) Splenic vein-preserving DP

(2) Superior mesenteric vein or portal vein invasion

(3) Pancreatic trauma

(4) Preoperative inflammatory pancreatic disease (pancreatitis)

(5) Requirement of anti-coagulant treatment during or after surgerya

(6) Severe ischemic cardiovascular disease

(7) Liver cirrhosis or active hepatitis

(8) Need for oxygen due to interstitial pneumonia or lung fibrosis

(9) Dialysis due to chronic renal failure

(10) Need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder

(11) Active multiple cancer that is thought to influence the occurrence of adverse events

(12) Difficulty with study participation due to psychotic disease or symptoms

(13) When a surgeon considers the use of stapler as inappropriate

(14) Inappropriate for the study objectives

  1. aAnti-coagulant treatment at 24 h after surgery is allowed
  2. DP distal pancreatectomy