## Protocol Section
### Identification Module
**NCT ID:** NCT02589379

**Acronym:** PMPPOPF

**Brief Title:** 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

#### Organization Study ID Info
**ID:** POPF-0134
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### Status Module
#### Completion Date
**Date:** 2019-05

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2016-01-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-01-16

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-07

**Status Verified Date:** 2016-01

#### Study First Post Date
**Date:** 2015-10-28
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-09
**Study First Submit QC Date:** 2015-10-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Zurich

#### Responsible Party

**Investigator Affiliation:** University of Zurich

**Investigator Full Name:** Mickael Lesurtel

**Investigator Title:** Professor, MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pancreatic Fistula

**Keywords:**

- postoperative pancreatic fistula

- soft and hard pancreas

### Design Module

#### Bio Spec

**Description:** Non-tumorous pancreatic tissue

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All consecutive patients undergoing pancreatic resection for benign or malignant disease and meet inclusion criteria.

**Intervention Names:**

- Procedure: Pancreatic Resection

**Label:** Pancreatic Resection

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pancreatic Resection

**Description:** Endoscopic ultrasound elastography, intraoperative ultrasound elastography and magnet resonance imaging to asses pancreatic stiffness prior to pancreatic resection

**Name:** Pancreatic Resection

**Type:** PROCEDURE

### Outcomes Module

#### 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.

**Time Frame:** 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.

**Time Frame:** 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.

**Time Frame:** 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.

**Time Frame:** 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.

**Time Frame:** 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.

**Time Frame:** within the 30 days after surgery

**Measure:** Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively.

**Time Frame:** within the 30 days after surgery

**Description:** within the 30 days after surgery

**Measure:** Intraclass correlation coefficient of the all measurements derived from EUE, IUE, MRI, surgeons assessment and histology.

**Time Frame:** within the 30 days after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients undergoing pancreatic resection for benign or malignant disease

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** henrik.petrowsky@usz.ch

**Name:** Henrik Petrowsky, Prof, MD

**Phone:** +41 44 255 30 41

**Role:** CONTACT

**Contact 2:**

**Email:** dilmurodjon.eshmuminov@usz.ch

**Name:** Dilmurodjon Eshmuminov, MD

**Phone:** +41 44 255 11 11

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Zurich

**Contacts:**

***Contact 1:***

- **Email:** henrik.petrowsky@usz.ch

- **Name:** Henrik Petrowsky, Prof, MD

- **Phone:** +41 44 255 30 41

- **Role:** CONTACT

***Contact 2:***

- **Email:** dilmurodjon.eshmuminov@usz.ch

- **Name:** Dilmurodjon Eshmuminov, MD

- **Phone:** +41 44 255 11 11

- **Role:** CONTACT

**Country:** Switzerland

**Facility:** University Hospital Zurich

**Status:** RECRUITING

**Zip:** 8091

#### Overall Officials

**Official 1:**

**Affiliation:** University of Zurich

**Name:** Henrik Petrowsky, Prof, MD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** 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.

**PMID:** 16003309

**Citation:** 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.

**PMID:** 15585382

**Citation:** 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.

**PMID:** 18043111

**Citation:** 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.

**PMID:** 19638926

**Citation:** 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.

**PMID:** 21963957

**Citation:** 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.

**PMID:** 9790207

**Citation:** 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.

**PMID:** 12170018

**Citation:** 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.

**PMID:** 24475834

**Citation:** 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.

**PMID:** 9073557

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000016154

- Term: Digestive System Fistula

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M8532

- Name: Fistula

- Relevance: HIGH

- As Found: Fistula

- ID: M13105

- Name: Pancreatic Fistula

- Relevance: HIGH

- As Found: Pancreatic Fistula

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M18616

- Name: Digestive System Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010185

- Term: Pancreatic Fistula

- ID: D000005402

- Term: Fistula

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M22554

- Name: Pancrelipase

- Relevance: LOW

- As Found: Unknown

- ID: M13114

- Name: Pancreatin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
