- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02589379
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Henrik Petrowsky, Prof, MD
- Número de teléfono: +41 44 255 30 41
- Correo electrónico: henrik.petrowsky@usz.ch
Copia de seguridad de contactos de estudio
- Nombre: Dilmurodjon Eshmuminov, MD
- Número de teléfono: +41 44 255 11 11
- Correo electrónico: dilmurodjon.eshmuminov@usz.ch
Ubicaciones de estudio
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Zurich, Suiza, 8091
- Reclutamiento
- University Hospital Zurich
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Contacto:
- Henrik Petrowsky, Prof, MD
- Número de teléfono: +41 44 255 30 41
- Correo electrónico: henrik.petrowsky@usz.ch
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Contacto:
- Dilmurodjon Eshmuminov, MD
- Número de teléfono: +41 44 255 11 11
- Correo electrónico: dilmurodjon.eshmuminov@usz.ch
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult (more than 18 years) with resectable pancreatic lesion(s)
Exclusion Criteria:
- Total pancreatectomy
- Unresectable pancreatic lesion(s)
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Pancreatic Resection
All consecutive patients undergoing pancreatic resection for benign or malignant disease and meet inclusion criteria.
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Endoscopic ultrasound elastography, intraoperative ultrasound elastography and magnet resonance imaging to asses pancreatic stiffness prior to pancreatic resection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: within the 30 days after surgery
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within the 30 days after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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.
Periodo de tiempo: within the 30 days after surgery
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within the 30 days after surgery
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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.
Periodo de tiempo: within the 30 days after surgery
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within the 30 days after surgery
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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.
Periodo de tiempo: within the 30 days after surgery
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within the 30 days after surgery
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Pearson correlation coefficient between preoperative MRI measurements of pancreatic fat (in %) with the fat content (in %) of the resected specimen on histology.
Periodo de tiempo: within the 30 days after surgery
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within the 30 days after surgery
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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.
Periodo de tiempo: within the 30 days after surgery
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within the 30 days after surgery
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Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively.
Periodo de tiempo: within the 30 days after surgery
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within the 30 days after surgery
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Intraclass correlation coefficient of the all measurements derived from EUE, IUE, MRI, surgeons assessment and histology.
Periodo de tiempo: within the 30 days after surgery
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within the 30 days after surgery
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within the 30 days after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Henrik Petrowsky, Prof, MD, University of Zurich
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- POPF-0134
Información sobre medicamentos y dispositivos, documentos del estudio
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