Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT02871804
Eligibility Criteria:
Inclusion Criteria:
* Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail
* ECOG Performance Status (PS) = 0-1
* Age ≥ 20 years old
* Maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.) (a) White blood cells ≥ 2,500/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 (v) Sufficient judgement to understand the study and to provide written informed consent
Exclusion Criteria:
* Splenic vein-preserving distal pancreatectomy
* Superior mesenteric vein or portal vein invasion
* Pancreatic trauma
* Preoperative inflammatory pancreatic disease (pancreatitis)
* Requirement of anti-coagulant treatment during or after surgery. Anti-coagulant treatment at 24 hrs after surgery is allowed.
* Severe ischemic cardiovascular disease
* Liver cirrhosis or active hepatitis
* Need for oxygen due to interstitial pneumonia or lung fibrosis
* Dialysis due to chronic renal failure
* Need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder
* Active multiple cancer that is thought to influence the occurrence of adverse events
* Difficulty with study participation due to psychotic disease or symptoms
* Inappropriate use of the stapler
* Inappropriate for the study objectives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02871804
Study Brief:
Protocol Section:
NCT02871804