Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

Study Overview
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Brief Summary
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For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Detailed Description
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For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Official Title
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Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Procedure: pancreaticoduodenectomy procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas. American Society of Anesthesiologists (ASA) scores I & II. Patients aged > 20 years. Agreement to complete the study. Exclusion Criteria: Patients with benign disease, trauma, and receive neoadjuvant therapy. double primary cancers.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinically relevant postoperative pancreatic fistula<br>patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy | Procedure: pancreaticoduodenectomy procedure<br>* Pancreaticoduodenectomy operation<br>|
| No clinically relevant postoperative pancreatic fistula<br>patients who did not develop clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy | Procedure: pancreaticoduodenectomy procedure<br>* Pancreaticoduodenectomy operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinically relevant post operative pancreatic fistula | A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk factors,, clinically relevant pancreatic fistula,, pancreaticoduodenectomy