Clinical trial NCT04582461: Role of Preoperative Multislice Computed Tomography in Whipple's Operation.
Official title: Role of Preoperative Multislice Computed Tomography to Predict the Risk of Pancreatic Fistula After Whipple's Operation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Fistula
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selection of average 100 patients expected to visit Assiut university hospitals for multislice computed tomography Abdomen before Whipple's operation according to the recorded flow on the Picture Archiving and Communication System (PACS) in the last year.

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: preoperative prediction of occurence of pancreatic fistula after Whipple's operation to enhance surveillance and further management as early as possible.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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