PMPPOPF: Ultrasound Elastography for Prediction of Postoperative Pancreatic Fistula

• Sponsor: University of Zurich (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02589379
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Duration (Months): 46
• Patients Per Site Per Month: 2

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Jul 1, 2015
• Anticipated Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: May 1, 2019

Arms and Interventions

Arm	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

Outcome Measures

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. [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. [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. [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. [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. [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. [within the 30 days after surgery]

6. Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively. [within the 30 days after surgery]

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Total pancreatectomy

• Unresectable pancreatic lesion(s)

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

• Study Chair: Henrik Petrowsky, Prof, MD, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mickael Lesurtel, Professor, MD, PhD, University of Zurich
• ClinicalTrials.gov Identifier: NCT02589379
• Other Study ID Numbers: POPF-0134
• First Posted: Oct 28, 2015
• Last Update Posted: Jan 20, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Mickael Lesurtel, Professor, MD, PhD, University of Zurich: postoperative pancreatic fistula; soft and hard pancreas
• Additional relevant MeSH terms: Pancreatic Fistula; Fistula

Study Results

No Results Posted as of Jan 20, 2016