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Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy

20 Years
Open (Enrolling)
Pancreatic Cancer, Pancreatic Cystic Lesions, Chronic Pancreatitis, Pancreatic Neuroendocrine Tumors, Pancreatic Pseudocysts

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Trial Information

Roux-en-Y Anastomosis of the Pancreatic Stump 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 .

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

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. Patients with laparoscopic distal pancreatectomy

6. Others, patients who are unfit for the study as determined by the attending physician

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of pancreatic fistula defined by ISGPF classification

Outcome Time Frame:

1 month after operation

Safety Issue:


Principal Investigator

Manabu Kawai, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wakayama Medical University, School of Medicine


Japan: Ministry of Health, Labor and Welfare

Study ID:

KNOW study-1101



Start Date:

June 2011

Completion Date:

June 2015

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cystic Lesions
  • Chronic Pancreatitis
  • Pancreatic Neuroendocrine Tumors
  • Pancreatic Pseudocysts
  • distal pancreatectomy
  • pancreatic fistula
  • pancreaticojejunostomy
  • Roux-en-Y anastomosis
  • stapling closure
  • Pancreatic Fistula
  • Pancreatic Neoplasms
  • Pancreatic Pseudocyst
  • Pancreatitis
  • Pancreatitis, Chronic
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell