An observational study in Pancreatic Fistula, sponsored by University of Zurich. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-20.
Sponsored by University of Zurich · Observational
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.
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.
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 90 is below the median of 173 across 49 observational studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing pancreatic resection for benign or malignant disease
Exclusion Criteria:
All consecutive patients undergoing pancreatic resection for benign or malignant disease and meet inclusion criteria.
Procedure: Pancreatic Resection
Endoscopic ultrasound elastography, intraoperative ultrasound elastography and magnet resonance imaging to asses pancreatic stiffness prior to pancreatic resection
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
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.
within the 30 days after surgery
Time frame: within the 30 days after surgery
This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Zurich