Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Wakayama Medical University
With
Osaka University
Nara Medical University
Kyoto Prefectural University of Medicine
Kansai Rosai Hospital
Hyogo Medical University
The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.
Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.
The primary endpoint in this trial was defined as the incidence of pancreatic fistula .
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. disease of pancreatic body and tail
2. PS (ECOG Performance Status Scale):0-1
3. Age: 20 years or older
4. distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis.
5. Adequate organ functions filled the following criteria within two weeks from enrollment:
1.White blood cell： \>3,500/mm3 or \<12,000/mm3 2.Neutrophilic leukocyte \>2,000/mm3 3.Platelet\>100,000/mm3 4.Hemoglobin \> 9.0g/dL 5.Total bilirubin \<2.0mg/dL 6.AST and ALT\<150IU/L 7.Creatinine \<1.5mg/dL 6)Patients who can provide written informed consent
You may not be if
1. Patients with severe liver cirrhosis or active hepatitis
2. Patients with respiratory illness that requires oxygen administration
3. .Patients with chronic renal failure requiring dialysis
4. Patients with active duplicative malignant disease affecting adverse event
5. Others, patients who are unfit for the study as determined by the attending physician
Clareo Health | Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy
