Ultrasound Elastography for Prediction of Postoperative Pancreatic Fistula

• Conditions: Pancreatic Fistula
• Interventions: Procedure: Pancreatic Resection

• Registration Number: NCT02589379
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-16
• Last Update Posted: 2016-01-20
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatic Resection	Pancreatic Resection	All consecutive patients undergoing pancreatic resection for benign or malignant disease and meet inclusion criteria.

Primary Outcome Measures

Name	Time	Method
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.	within the 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Intraclass correlation coefficient of the all measurements derived from EUE, IUE, MRI, surgeons assessment and histology.	within the 30 days after surgery	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.	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.	within the 30 days after surgery
Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively.	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.	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.	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.	within the 30 days after surgery

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland