Ultrasound Elastography for Prediction of Postoperative Pancreatic Fistula (PMPPOPF)

The Value of Endoscopic Ultrasound Elastography for Prediction of Pancreatic Fistula in Patients Undergoing Pancreatic Resection for Benign or Malignant Disease

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Fistula
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Henrik Petrowsky, Prof, MD; Phone Number: +41 44 255 30 41; Email: henrik.petrowsky@usz.ch
    • Contact: Dilmurodjon Eshmuminov, MD; Phone Number: +41 44 255 11 11; Email: dilmurodjon.eshmuminov@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing pancreatic resection for benign or malignant disease

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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 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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
• Lin JW, Cameron JL, Yeo CJ, Riall TS, Lillemoe KD. Risk factors and outcomes in postpancreaticoduodenectomy pancreaticocutaneous fistula. J Gastrointest Surg. 2004 Dec;8(8):951-9. doi: 10.1016/j.gassur.2004.09.044.
• Mathur A, Pitt HA, Marine M, Saxena R, Schmidt CM, Howard TJ, Nakeeb A, Zyromski NJ, Lillemoe KD. Fatty pancreas: a factor in postoperative pancreatic fistula. Ann Surg. 2007 Dec;246(6):1058-64. doi: 10.1097/SLA.0b013e31814a6906.
• Nathan H, Cameron JL, Goodwin CR, Seth AK, Edil BH, Wolfgang CL, Pawlik TM, Schulick RD, Choti MA. Risk factors for pancreatic leak after distal pancreatectomy. Ann Surg. 2009 Aug;250(2):277-81. doi: 10.1097/SLA.0b013e3181ae34be.
• Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich CF, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Efficacy of an artificial neural network-based approach to endoscopic ultrasound elastography in diagnosis of focal pancreatic masses. Clin Gastroenterol Hepatol. 2012 Jan;10(1):84-90.e1. doi: 10.1016/j.cgh.2011.09.014. Epub 2011 Oct 1.
• Sato N, Yamaguchi K, Chijiiwa K, Tanaka M. Risk analysis of pancreatic fistula after pancreatic head resection. Arch Surg. 1998 Oct;133(10):1094-8. doi: 10.1001/archsurg.133.10.1094.
• Schafer M, Mullhaupt B, Clavien PA. Evidence-based pancreatic head resection for pancreatic cancer and chronic pancreatitis. Ann Surg. 2002 Aug;236(2):137-48. doi: 10.1097/00000658-200208000-00001.
• Watanabe H, Kanematsu M, Tanaka K, Osada S, Tomita H, Hara A, Goshima S, Kondo H, Kawada H, Noda Y, Tanahashi Y, Kawai N, Yoshida K, Moriyama N. Fibrosis and postoperative fistula of the pancreas: correlation with MR imaging findings--preliminary results. Radiology. 2014 Mar;270(3):791-9. doi: 10.1148/radiol.13131194. Epub 2013 Nov 8.
• Yeh TS, Jan YY, Jeng LB, Hwang TL, Wang CS, Chen SC, Chao TC, Chen MF. Pancreaticojejunal anastomotic leak after pancreaticoduodenectomy--multivariate analysis of perioperative risk factors. J Surg Res. 1997 Feb 1;67(2):119-25. doi: 10.1006/jsre.1996.4974.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 16, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: postoperative pancreatic fistula; soft and hard pancreas
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: POPF-0134

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No