Pancreas Adenocarcinoma, Pancreas Cancer, Pancreas Neoplasm, Pancreatic Fistula, Periampullary Cancer, Periampullary Carcinoma, Resectable Pancreatic Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREpancreaticoduodenectomy procedure
Pancreaticoduodenectomy operation
Sponsors
Minia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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: * No evidence of metastasis. * Radiological non-involvement of superior mesenteric vein \& portal vein. * 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
* Unfit patients for surgery due to severe medical illness. * Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs. * Irresectable tumors in diagnostic laparoscopy. * History of other malignant disease. * Pregnant or breast-feeding women. * Patients with serious mental disorders. * Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data. * Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis * Patients refused to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of 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 |
Countries
Egypt
Contacts
CONTACTSaleh K Saleh, MD
PRINCIPAL_INVESTIGATORSaleh K Saleh, MD
Minia University
Outcome results
None listed