Pancreatic FistulaNCT04582461
Role of Preoperative Multislice Computed Tomography in Whipple's Operation.
An observational study of Pancreatic Fistula, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- multislice computed tomography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Preoperative Multislice Computed Tomography to Predict the Risk of Pancreatic Fistula After Whipple's Operation.
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.
Read the 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).
- Conditions
- Pancreatic Fistula
- Being tested
- multislice computed tomography
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multislice computed tomographyDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelbaset Mahmoud Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582461
- Sponsor's protocol ID
- multislice computed tomography
- Status last verified
- Oct 2020
- First submitted
- 23 Sep 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ilic M, Ilic I. Epidemiology of pancreatic cancer. World J Gastroenterol. 2016 Nov 28;22(44):9694-9705. doi: 10.3748/wjg.v22.i44.9694.
PubMed 27956793Bray 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.
PubMed 30207593Hidalgo 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.
PubMed 25547205Siegel 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.
PubMed 26742998Mohammed 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.
PubMed 25071330Bassi 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.
PubMed 16003309Enestvedt 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.
PubMed 22464011Huttner 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.
PubMed 26905229Koti 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.
PubMed 20590882Lermite 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.
PubMed 17382217Lin 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.
PubMed 15585382Callery 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.
PubMed 23122535Sandini 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.
PubMed 26252274Kirihara 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.
PubMed 23241871McAuliffe 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.
PubMed 23458275
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Preoperative Multislice Computed Tomography to Predict the Risk of Pancreatic Fistula After Whipple's Operation.
- ClinicalTrials.gov ID
- NCT04582461
- Acronym / sponsor ID
- multislice computed tomography
- Conditions
- Pancreatic Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multislice computed tomographyAll 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. | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Background: PubMed 27956793Ilic M, Ilic I. Epidemiology of pancreatic cancer. World J Gastroenterol. 2016 Nov 28;22(44):9694-9705. doi: 10.3748/wjg.v22.i44.9694.
- Background: PubMed 30207593Bray 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.
- Background: PubMed 25547205Hidalgo 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.
- Background: PubMed 26742998Siegel 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.
- Background: PubMed 25071330Mohammed 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.
- Background: PubMed 16003309Bassi 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.
- Background: PubMed 22464011Enestvedt 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.
- Background: PubMed 26905229Huttner 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.
- Background: PubMed 20590882Koti 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.
- Background: PubMed 17382217Lermite 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.
- Background: PubMed 15585382Lin 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.
- Background: PubMed 23122535Callery 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Fistula, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Abdelbaset (00201121244528, mahmoudabdo5000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative prediction of occurence of pancreatic fistula after Whipple's operation to enhance surveillance and further management as early as possible. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04582461, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.