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Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD. The total number of 100 participants expected to be included in this research who underwent PD between 2025 and 2026.
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. This study aimed to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinically relevant postoperative pancreatic fistula | Other | patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pancreaticoduodenectomy procedure | Procedure | Pancreaticoduodenectomy operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 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 |
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Inclusion Criteria:
Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
Patients meeting the curative treatment intent in accordance with clinical guidelines:
American Society of Anesthesiologists (ASA) scores I & II.
Patients aged > 18 years.
Ability to understand and the willingness to sign a written informed consent document
Agreement to complete the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saleh K Saleh, MD | Contact | 01201765401 | +2 | salehkhairy@mu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Saleh K Saleh, MD | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver and GIT hospital , Minia University | Recruiting | Minya | 61519 | Egypt |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |