Clinical trial NCT02589379: Ultrasound Elastography for Prediction of Postoperative Pancreatic Fistula
Official title: The Value of Endoscopic Ultrasound Elastography for Prediction of Pancreatic Fistula in Patients Undergoing Pancreatic Resection for Benign or Malignant Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Fistula
Keywords: postoperative pancreatic fistula
soft and hard pancreas
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult (more than 18 years) with resectable pancreatic lesion(s)

Exclusion Criteria:

* Total pancreatectomy
* Unresectable pancreatic lesion(s)
* Pregnancy

Primary outcomes:
measure: 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.
timeFrame: within the 30 days after surgery
Secondary outcomes:
measure: 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.
timeFrame: within the 30 days after surgery
measure: 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.
timeFrame: within the 30 days after surgery
measure: 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.
timeFrame: within the 30 days after surgery
measure: Pearson correlation coefficient between preoperative MRI measurements of pancreatic fat (in %) with the fat content (in %) of the resected specimen on histology.
timeFrame: within the 30 days after surgery
measure: 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.
timeFrame: within the 30 days after surgery
measure: Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively.
timeFrame: within the 30 days after surgery
measure: Intraclass correlation coefficient of the all measurements derived from EUE, IUE, MRI, surgeons assessment and histology.
timeFrame: within the 30 days after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Henrik Petrowsky, Prof, MD
role: STUDY_CHAIR
References:
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