Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula
Study Details
Study Description
Brief Summary
Pancreaticoduodenectomy (PD) procedure is one of the standard treatments for benign and malignant diseases of the periampullary region and head of the pancreas. However, PD is still technically challenging and has significant rates of morbidity (up to 50%) and mortality (up to 5%). Currently, postoperative pancreatic fistula (POPF) represents the most critical and life-threatening complication after PD with reported incidences of total POPF from 2-60% and for clinically relevant (CR)-POPF from 5-40%. CR-POPF results in abdominal abscess, delayed gastric emptying, pseudoaneurysms, and bleeding which have been linked to a mortality rate of 40% or higher. Also, it is associated with increased hospital admission, healthcare costs, and several reinterventions, resulting in poor quality of patient life. The aim of this study was to identify the operative risk factors for CR-POPF post-PD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Pancreaticoduodenectomy (PD) procedure is one of the standard treatments for benign and malignant diseases of the periampullary region and head of the pancreas. However, PD is still technically challenging and has significant rates of morbidity (up to 50%) and mortality (up to 5%). Currently, postoperative pancreatic fistula (POPF) represents the most critical and life-threatening complication after PD with reported incidences of total POPF from 2-60% and clinically relevant (CR)-POPF from 5-40%. CR-POPF results in abdominal abscess, delayed gastric emptying, pseudoaneurysms, and bleeding which have been linked to a mortality rate of 40% or higher. Also, it is associated with increased hospital admission, healthcare costs, and several reinterventions, resulting in poor quality of patient life.
Although, improvements in operative techniques and postoperative care, CR-POPF is still regarded as the most challenging and severe complication following PD, and it represents the main issue prohibiting surgeons from performing PD. Many risk factors for CR-POPF have been reported as patient-related risk factors (age, sex, obesity, preoperative bilirubin level, pancreatic texture, main pancreatic duct diameter (MPDD), and pathological type), and surgical procedure-related risk factors (type of PD, types of anastomosis, methods of pancreatic reconstruction, blood loss and transfusion, operative time and the surgeon's experiences). However, no definite factor has yet been identified. As the CR-POPF rate is decreased, morbidity and will even mortality rates will decrease. Various procedures have been developed in an effort to reduce leak rates, such as pancreaticojejunostomy (PJ) vs. pancreaticogastrostomy (PG), end-to-side vs. end-to-end PJ, duct-to-mucosa vs. dunking anastomosis, and use of an internal vs. external stent, however, the optimal surgical procedure to reduce CR-POPF rates is still debatable. The aim of this study was to identify the operative risk factors for CR-POPF post-PD.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Clinically relevant postoperative pancreatic fistula patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy |
Procedure: pancreaticoduodenectomy procedure
Pancreaticoduodenectomy operation
|
| No clinically relevant postoperative pancreatic fistula patients who did not develop clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy |
Procedure: pancreaticoduodenectomy procedure
Pancreaticoduodenectomy operation
|
Outcome Measures
Primary Outcome Measures
- clinically relevant post operative pancreatic fistula [10 days]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
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American Society of Anesthesiologists (ASA) scores I & II.
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Patients aged > 20 years.
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Agreement to complete the study.
Exclusion Criteria:
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Patients with benign disease, trauma, and receive neoadjuvant therapy.
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double primary cancers.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qena faculty of Medicine, South Valley University | Cairo | Egypt |
Sponsors and Collaborators
- South Valley University
Investigators
- Principal Investigator: Mohammed A Omar, M.D., General Surgery Department, Faculty of Medicine, South Valley University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SVU/MED/SUR011/4/23/1/515