Ultrasound Elastography for Prediction of Postoperative Pancreatic Fistula (PMPPOPF)
2016年1月16日 更新者：Mickael Lesurtel、University of Zurich
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
90
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Henrik Petrowsky, Prof, MD
- 电话号码：+41 44 255 30 41
- 邮箱：henrik.petrowsky@usz.ch
研究联系人备份
- 姓名：Dilmurodjon Eshmuminov, MD
- 电话号码：+41 44 255 11 11
- 邮箱：dilmurodjon.eshmuminov@usz.ch
学习地点
-
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Zurich、瑞士、8091
- 招聘中
- University Hospital Zurich
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接触：
- Henrik Petrowsky, Prof, MD
- 电话号码：+41 44 255 30 41
- 邮箱：henrik.petrowsky@usz.ch
-
接触：
- Dilmurodjon Eshmuminov, MD
- 电话号码：+41 44 255 11 11
- 邮箱：dilmurodjon.eshmuminov@usz.ch
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients undergoing pancreatic resection for benign or malignant disease
描述
Inclusion Criteria:
- Adult (more than 18 years) with resectable pancreatic lesion(s)
Exclusion Criteria:
- Total pancreatectomy
- Unresectable pancreatic lesion(s)
- Pregnancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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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.
大体时间：within the 30 days after surgery
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within the 30 days after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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.
大体时间：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.
大体时间：within the 30 days after surgery
|
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.
大体时间：within the 30 days after surgery
|
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.
大体时间：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.
大体时间：within the 30 days after surgery
|
within the 30 days after surgery
|
|
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Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively.
大体时间：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.
大体时间：within the 30 days after surgery
|
within the 30 days after surgery
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within the 30 days after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Henrik Petrowsky, Prof, MD、University of Zurich
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年7月1日
初级完成 (预期的)
2019年5月1日
研究完成 (预期的)
2019年5月1日
研究注册日期
首次提交
2015年10月9日
首先提交符合 QC 标准的
2015年10月26日
首次发布 (估计)
2015年10月28日
研究记录更新
最后更新发布 (估计)
2016年1月20日
上次提交的符合 QC 标准的更新
2016年1月16日
最后验证
2016年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.