Role of Preoperative Multislice Computed Tomography in Whipple's Operation.

Study Overview
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Brief Summary
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Preoperative assessment of visceral fat volume(VFV),total fat volume(TFV),pancreas/spleen density ratio and pancreatic duct diameter by multislice computed tomography abdomen to predict the risk of pancreatic fistula after Whipple's operation.

Detailed Description
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pancreatic cancer has ranked the 11th most common cancer in the world and seventh leading cause of cancer-related deaths worldwide. Worldwide incidence and mortality of pancreatic cancer correlate with increasing age and is slightly more common in men than in women(1). There are many risk factors for pancreatic cancer, such as age, tobacco smoking, heavy alcohol consumption, obesity, low physical activity, chronic pancreatitis, long-standing type 2 diabetes, ABO blood type, and family history(2). Pancreatic cancer is mainly divided into two types of pancreatic cancer: pancreatic adenocarcinoma, which is the most common (85% of cases) arising in exocrine glands of the pancreas, and pancreatic neuroendocrine tumor (PanNET), which is less common (less than 5%) and occurs in the endocrine tissue of the pancreas.Signs and symptoms of pancreatic cancer often don't occur until the disease is advanced(3). Upon progression of the tumor, it manifests as a gradual onset of non-specific symptoms including jaundice, weight loss, light-colored stools, abdominal pain and fatigue(4). Treatment for pancreatic cancer depends on the stage and location of the cancer as well as on your overall health and personal preferences. Surgery, chemotherapy and radiotherapy are traditionally used to extend survival and/or relieve the patients' symptoms. However, for advanced-stage cancer cases, there is still no definite cure(5). Postoperative pancreatic fistula (POPF) remains one of the most frequent and threatening complication after pancreatoduodenectomy (PD). The occurrence ranges from 10% to 30%(6). Depending on its severity, it may be responsible for distant organ dysfunction and subsequent mortality, prolonged length of in-hospital stay, and increased health care costs(7). Both prevention and treatment of POPF are challenging. Among the potential strategies to reduce the incidence and the severity of POPF, different surgical techniques(8) have been proposed along with the perioperative inhibition of exocrine pancreatic secretion(9). An additional key factor to improve patient management may be to find reliable means of calculating and predicting the risk of POPF. The ability of anticipating the risk of POPF before surgery based on peculiar patient features might establish a more customized preoperative program for patients with high risk of fistula, potentially excluding subjects with elevated risk from surgical resection or to set up protocols for a strict and early detection of warning clinical scenario .Previous studies and reviews described different variables correlated to the occurrence of POPF, in particular, patient characteristics such as American Society of Anesthesiology score, body mass index, age, malnutrition, muscle cachexia, medical history and morbidities(10)(11)and intraoperative findings, that is, small Wirsung duct diameter, soft pancreatic texture, and estimated blood loss(12). The multivariate analysis revealed that a visceral fat volume(VFV) >2334 cm3,total fat volume(TFV) >4408 cm3, pancreas/spleen density ratio <0.707, and pancreatic duct diameter <5mm were predictive of POPF(13). Also baseline radiological findings, such as fat distribution, radiological characteristics of abdominal skeletal muscles, estimated pancreatic remnant volume, and pathway of the enhancement attenuation have been correlated with the risk of complication development and POPF, but with inconsistent results(14)(15).

Official Title
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Role of Preoperative Multislice Computed Tomography to Predict the Risk of Pancreatic Fistula After Whipple's Operation.

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Device: multislice computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients referred to the radiology department for multislice computed tomography Abdomen examination for preoperative evaluation before Whipple's operation over the estimated period of the study. Exclusion Criteria: Patients with contraindications to multislice computed tomography as a history of reactions to contrast agents, radioactive iodine treatment for thyroid disease, metformin use, and chronic or acutely worsening renal disease.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: multislice computed tomography|All patients will undergo a preoperative multiphasic multidetector CT scan before surgery.The unenhanced scan will be used to generate a CT reconstruction of the upper abdomen (from the diaphragm to the kidneys) with a 5mm thickness. Two different radiologists (D.F. and D.I.), blinded to patient information, measured total fat volume (TFV), visceral fat volume (VFV), and analyzed pixels with densities in the - 190 hounsfield units (HU) to - 20 HU range. the ratio between the density of the pancreas over the density of the spleen will be calculated and the maximum diameter of the pancreatic duct will be measured using the arterial phase in order to better identify the entire length of the duct.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative prediction of occurence of pancreatic fistula after Whipple's operation to enhance surveillance and further management as early as possible. | Preoperative assessment mainly abdominal fat distribution (expressed in centimeter cubic) by multislice computed tomography abdomen to predict the risk of pancreatic fistula after Whipple's operation. | Baseline |