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.
Full Title of Study: “Role of Preoperative Multislice Computed Tomography to Predict the Risk of Pancreatic Fistula After Whipple’s Operation.”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 1, 2022
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).
- 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.
Clinical Trial Outcome Measures
- preoperative prediction of occurence of pancreatic fistula after Whipple’s operation to enhance surveillance and further management as early as possible.
- Time Frame: Baseline
- 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.
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: 80 Years
- Lead Sponsor
- Assiut University
- Provider of Information About this Clinical Study
- Principal Investigator: Mahmoud Abdelbaset Mahmoud Mohamed, Principal investigator – Assiut University
- Overall Contact(s)
- Mahmoud Abdelbaset, 00201121244528, firstname.lastname@example.org
Ilic M, Ilic I. Epidemiology of pancreatic cancer. World J Gastroenterol. 2016 Nov 28;22(44):9694-9705. Review.
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313.
Hidalgo M, Cascinu S, Kleeff J, Labianca R, Löhr JM, Neoptolemos J, Real FX, Van Laethem JL, Heinemann V. Addressing the challenges of pancreatic cancer: future directions for improving outcomes. Pancreatology. 2015 Jan-Feb;15(1):8-18. doi: 10.1016/j.pan.2014.10.001. Epub 2014 Oct 17. Review.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
Mohammed S, Van Buren G 2nd, Fisher WE. Pancreatic cancer: advances in treatment. World J Gastroenterol. 2014 Jul 28;20(28):9354-60. doi: 10.3748/wjg.v20.i28.9354. Review.
Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. Review.
Enestvedt CK, Diggs BS, Cassera MA, Hammill C, Hansen PD, Wolf RF. Complications nearly double the cost of care after pancreaticoduodenectomy. Am J Surg. 2012 Sep;204(3):332-8. doi: 10.1016/j.amjsurg.2011.10.019. Epub 2012 Mar 29.
Hüttner FJ, Fitzmaurice C, Schwarzer G, Seiler CM, Antes G, Büchler MW, Diener MK. Pylorus-preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma. Cochrane Database Syst Rev. 2016 Feb 16;2:CD006053. doi: 10.1002/14651858.CD006053.pub6. Review.
Koti RS, Gurusamy KS, Fusai G, Davidson BR. Meta-analysis of randomized controlled trials on the effectiveness of somatostatin analogues for pancreatic surgery: a Cochrane review. HPB (Oxford). 2010 Apr;12(3):155-65. doi: 10.1111/j.1477-2574.2010.00157.x. Review.
Lermite E, Pessaux P, Brehant O, Teyssedou C, Pelletier I, Etienne S, Arnaud JP. Risk factors of pancreatic fistula and delayed gastric emptying after pancreaticoduodenectomy with pancreaticogastrostomy. J Am Coll Surg. 2007 Apr;204(4):588-96. Epub 2007 Mar 2.
Lin JW, Cameron JL, Yeo CJ, Riall TS, Lillemoe KD. Risk factors and outcomes in postpancreaticoduodenectomy pancreaticocutaneous fistula. J Gastrointest Surg. 2004 Dec;8(8):951-9.
Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
Sandini M, Bernasconi DP, Ippolito D, Nespoli L, Baini M, Barbaro S, Fior D, Gianotti L. Preoperative Computed Tomography to Predict and Stratify the Risk of Severe Pancreatic Fistula After Pancreatoduodenectomy. Medicine (Baltimore). 2015 Aug;94(31):e1152. doi: 10.1097/MD.0000000000001152.
Kirihara Y, Takahashi N, Hashimoto Y, Sclabas GM, Khan S, Moriya T, Sakagami J, Huebner M, Sarr MG, Farnell MB. Prediction of pancreatic anastomotic failure after pancreatoduodenectomy: the use of preoperative, quantitative computed tomography to measure remnant pancreatic volume and body composition. Ann Surg. 2013 Mar;257(3):512-9. doi: 10.1097/SLA.0b013e31827827d0.
McAuliffe JC, Parks K, Kumar P, McNeal SF, Morgan DE, Christein JD. Computed tomography attenuation and patient characteristics as predictors of complications after pancreaticoduodenectomy. HPB (Oxford). 2013 Sep;15(9):709-15. doi: 10.1111/hpb.12037. Epub 2013 Jan 10.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.