Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

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 .

• Stapling closure of the pancreatic stump (Procedure): 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.
• Roux-en-Y anastomosis of the pancreatic stump (Procedure): end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.

Primary outcomes

• Incidence of pancreatic fistula defined by ISGPF classification [3 month after operation]

Secondary outcomes

• morbidity [3 months after opeartion]
• 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]
• mortality [3 months after operation]
• 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]

Sex: All, ages: 20 Years to any

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

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• Manabu Kawai, MD, Principal investigator, Wakayama Medical University, School of Medicine