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Randomized controlled multicenter trial assessing Roux-en-Y anastomosis of the pancreatic stump to prevent pancreatic fistula following distal pancreatectomy

Not Applicable
Conditions
disease of pancreatic body and tail
Registration Number
JPRN-UMIN000005722
Lead Sponsor
Wakayama Medical University, School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
136
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of pancreatic fistula defined by ISGPF
Secondary Outcome Measures
NameTimeMethod
1)morbidity 2)mortality 3)postoperative hospital stay 4)new onset or worsening diabetes 5)nutritional status 6)quality of life 7) Incidence of pancreatic fistula grade B/C 8) Incidence of pancreatic fistula grade C 9) Incidence of intraabdominal bleeding 10) Incidence of pancreatic fistula based on thickness of the pancreas
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