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Ultrasound Elastography for Prediction of Postoperative Pancreatic Fistula (PMPPOPF)

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ClinicalTrials.gov Identifier: NCT02589379
Recruitment Status : Unknown
Verified January 2016 by Mickael Lesurtel, University of Zurich.
Recruitment status was:  Recruiting
First Posted : October 28, 2015
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Mickael Lesurtel, 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.

Condition or disease Intervention/treatment
Pancreatic Fistula Procedure: Pancreatic Resection

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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Value of Endoscopic Ultrasound Elastography for Prediction of Pancreatic Fistula in Patients Undergoing Pancreatic Resection for Benign or Malignant Disease
Study Start Date : July 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas Ultrasound

Group/Cohort Intervention/treatment
Pancreatic Resection
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively. [ Time Frame: within the 30 days after surgery ]
  7. 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


Biospecimen Retention:   Samples Without DNA
Non-tumorous pancreatic tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing pancreatic resection for benign or malignant disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589379


Contacts
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Contact: Henrik Petrowsky, Prof, MD +41 44 255 30 41 henrik.petrowsky@usz.ch
Contact: Dilmurodjon Eshmuminov, MD +41 44 255 11 11 dilmurodjon.eshmuminov@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Henrik Petrowsky, Prof, MD    +41 44 255 30 41    henrik.petrowsky@usz.ch   
Contact: Dilmurodjon Eshmuminov, MD    +41 44 255 11 11    dilmurodjon.eshmuminov@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Study Chair: Henrik Petrowsky, Prof, MD University of Zurich

Publications of Results:

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Responsible Party: Mickael Lesurtel, Professor, MD, PhD, University of Zurich
ClinicalTrials.gov Identifier: NCT02589379     History of Changes
Other Study ID Numbers: POPF-0134
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Mickael Lesurtel, University of Zurich:
postoperative pancreatic fistula
soft and hard pancreas

Additional relevant MeSH terms:
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Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases