Chronic Pancreatitis, Pancreatic Cancer, Pancreatic Cystic Lesions, Pancreatic Neuroendocrine Tumors, Pancreatic Pseudocysts
Conditions
Keywords
distal pancreatectomy, pancreatic fistula, pancreaticojejunostomy, Roux-en-Y anastomosis, stapling closure
Brief summary
The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.
Detailed description
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 .
Interventions
PROCEDUREStapling closure of the pancreatic stump
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.
PROCEDURERoux-en-Y anastomosis of the pancreatic stump
end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
Sponsors
Osaka University
Nara Medical University
Kyoto Prefectural University of Medicine
Kansai Rosai Hospital
Hyogo Medical University
Wakayama Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pancreatic fistula defined by ISGPF classification | 3 month after operation |
Secondary
| Measure | Time frame |
|---|---|
| postoperative hospital stay | 3 month after operation |
| quality of life | 2 years after operation |
| new onset or worsening diabetes | 2 years after opeartion |
| nutritional status | 2 years after opeartion |
| morbidity | 3 months after opeartion |
| Incidence of pancreatic fistula gradeB/C defined by ISGPF classification | 3 months after oepration |
| Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma | 3 months after oepration |
| Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma | 3 months after operation |
| mortality | 3 months after operation |
Countries
Japan
Outcome results
None listed