Role of Preoperative Multislice Computed Tomography in Whipple's Operation.
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedOctober 9, 2020
October 1, 2020
1 year
September 23, 2020
October 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (15)
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PMID: 27956793BACKGROUNDBray 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.
PMID: 30207593BACKGROUNDHidalgo M, Cascinu S, Kleeff J, Labianca R, Lohr 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.
PMID: 25547205BACKGROUNDSiegel 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.
PMID: 26742998BACKGROUNDMohammed 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.
PMID: 25071330BACKGROUNDBassi 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. doi: 10.1016/j.surg.2005.05.001.
PMID: 16003309BACKGROUNDEnestvedt 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.
PMID: 22464011BACKGROUNDHuttner FJ, Fitzmaurice C, Schwarzer G, Seiler CM, Antes G, Buchler 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(2):CD006053. doi: 10.1002/14651858.CD006053.pub6.
PMID: 26905229BACKGROUNDKoti 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.
PMID: 20590882BACKGROUNDLermite 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. doi: 10.1016/j.jamcollsurg.2007.01.018. Epub 2007 Mar 2.
PMID: 17382217BACKGROUNDLin 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. doi: 10.1016/j.gassur.2004.09.044.
PMID: 15585382BACKGROUNDCallery 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.
PMID: 23122535BACKGROUNDSandini 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.
PMID: 26252274BACKGROUNDKirihara 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.
PMID: 23241871BACKGROUNDMcAuliffe 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.
PMID: 23458275BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 23, 2020
First Posted
October 9, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
February 1, 2022
Last Updated
October 9, 2020
Record last verified: 2020-10