Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy
Pancreatic Cancer, Pancreatic Cystic Lesions, Chronic Pancreatitis
About this trial
This is an interventional prevention trial for Pancreatic Cancer focused on measuring distal pancreatectomy, pancreatic fistula, pancreaticojejunostomy, Roux-en-Y anastomosis, stapling closure
Eligibility Criteria
Inclusion Criteria:
- disease of pancreatic body and tail
- PS (ECOG Performance Status Scale):0-1
- Age: 20 years or older
- 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.
- 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
Exclusion Criteria:
- Patients with severe liver cirrhosis or active hepatitis
- Patients with respiratory illness that requires oxygen administration
- .Patients with chronic renal failure requiring dialysis
- Patients with active duplicative malignant disease affecting adverse event
- Others, patients who are unfit for the study as determined by the attending physician
Sites / Locations
- Second Department of Surgery, Wakayama Medical University, School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Roux-en-Y anastomosis of the pancreatic stump
Stapling closure of the pancreatic stump
end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.