Clinical Trial: Ultrasound Elastography for Prediction of Postoperative Pancreatic Fistula

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Value of Endoscopic Ultrasound Elastography for Prediction of Pancreatic Fistula in Patients Undergoing Pancreatic Resection for Benign or Malignant Disease

Brief Summary: The purpose of this study is to assess the value of preoperative objective modalities such as endoscopic ultrasound elastography and magnet resonance imaging in predicting development of postoperative pancreatic fistula in patients undergoing pancreatic surgery for benign or malignant disease.

Detailed Summary:

One of the most generally accepted causes of postoperative pancreatic fistula (POPF) is soft texture of the pancreas. The stiffness of organs depends on histologic features such as content of fat, fibrotic tissue and micro vascular structures. Yet, pancreatic stiffness was evaluated only subjectively. Endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) may allow objective quantification of pancreatic stiffness prior to surgery.

Endoscopic ultrasound elastography (EUE) is based on real-time Doppler technology. Image colors are derived from vibration patterns which depend on the stiffness of a specific region of the investigated organ. The retrieved images could be converted into numeric matrix using a specially designed program.

Magnetic resonance imaging (MRI) is a non-invasive method for quantitatively assessing the mechanical properties of tissues based on fat tissue content.

In this trial the investigators will assess at first the value of EUE and MRI in predicting development of postoperative pancreatic fistula and in a next step the value EUE and MRI as an objective method in prediction of pancreatic stiffness.


Sponsor: University of Zurich

Current Primary Outcome: POPF rate (in %) as defined by the International Study Group on Pancreatic Fistula (ISGPF) in the soft versus hard pancreas group based on the median EUE stiffness measurements generated by values derived from hue histograms. [ Time Frame: within the 30 days after surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pearson correlation coefficient between preoperative EUE measurements of pancreatic stiffness generated by values derived from hue histograms with the fat content (in %) of the resected specimen on histology. [ Time Frame: within the 30 days after surgery ]
  • Pearson correlation coefficient between preoperative EUE measurements of pancreatic stiffness generated by values derived from hue histograms with intra-operative ultrasound elastography measurements generated by values derived from hue histograms. [ Time Frame: within the 30 days after surgery ]
  • Postoperative pancreatic fistula rate (in %) as defined by the ISGPF in the soft versus hard pancreas group based on the median MRI fat measurement (in %) on histology. [ Time Frame: within the 30 days after surgery ]
  • Pearson correlation coefficient between preoperative MRI measurements of pancreatic fat (in %) with the fat content (in %) of the resected specimen on histology. [ Time Frame: within the 30 days after surgery ]
  • Postoperative pancreatic fistula rate (in %) as defined by the ISGPF in the soft versus hard pancreas group based on the surgeons assessment of stiffness on a visual analogue scale from soft (0) to hard (10) intraoperatively. [ Time Frame: within the 30 days after surgery ]
  • Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively. [ Time Frame: within the 30 days after surgery ]
  • Intraclass correlation coefficient of the all measurements derived from EUE, IUE, MRI, surgeons assessment and histology. [ Time Frame: within the 30 days after surgery ]
    within the 30 days after surgery


Original Secondary Outcome:

  • Pearson correlation coefficient between preoperative EUE measurements of pancreatic stiffness generated by values derived from hue histograms with the fat content (in %) of the resected specimen on histology. [ Time Frame: within the 30 days after surgery ]
  • Pearson correlation coefficient between preoperative EUE measurements of pancreatic stiffness generated by values derived from hue histograms with intra-operative ultrasound elastography measurements generated by values derived from hue histograms. [ Time Frame: within the 30 days after surgery ]
  • Postoperative pancreatic fistula rate (in %) as defined by the ISGPF in the soft versus hard pancreas group based on the median MRI fat measurement (in %) on histology. [ Time Frame: within the 30 days after surgery ]
  • Pearson correlation coefficient between preoperative MRI measurements of pancreatic fat (in %) with the fat content (in %) of the resected specimen on histology. [ Time Frame: within the 30 days after surgery ]
  • Postoperative pancreatic fistula rate (in %) as defined by the ISGPF in the soft versus hard pancreas group based on the surgeons assessment of stiffness on a visual analogue scale from soft (0) to hard (10) intraoperatively. [ Time Frame: within the 30 days after surgery ]
  • Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively. [ Time Frame: within the 30 days after surgery ]


Information By: University of Zurich

Dates:
Date Received: October 9, 2015
Date Started: July 2015
Date Completion: May 2019
Last Updated: January 16, 2016
Last Verified: January 2016