Clinical trial NCT01455610: Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study
Official title: Preoperative Evaluation of Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenocarcinoma of Head of Pancreas
Keywords: Computed tomography
Contrast enhancement
Pancreas
Cancer
Resectability
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Shanghai Cancer Hospital, China
name: Ruijin Hospital
name: Huashan Hospital
name: Huadong Hospital
First posted: 2011-10-20
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Out-patients or in-patients,with(or suspected) pancreatic head cancer, both have MDCT examinaton and receive surgery treatment

Brief summary: The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.


Eligibility criteria: Inclusion Criteria:

* Patients with (or suspected) pancreatic head cancer
* Being examined by contrasted-enhanced MDCT
* Receiving surgical treatment (including palliative surgery) in all research centers

Exclusion Criteria:

* Patients having (or suspected) pregnancy or breast-feeding
* Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs)
* Patients receiving ERCP before contrasted-enhanced MDCT examination
* Patients without surgery because of a high degree of surgical risk

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Radiology Department, Ruijing Hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Radiology Department, Cancer Hospital, Fuandan University
state: Shanghai
city: Shanghai
country: China
facility: Radiology Department, Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Radiology Department, Huadong Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Radiology Department, Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Radiology Department, Changhai Hospital Affiliated to the Second Military Medical University
state: Shanghai
Study officials:
affiliation: Radiology Department, Zhongshan Hospital of Fudan University
name: Mengsu Zeng, MD, PhD
role: STUDY_CHAIR
affiliation: Radiology Department, Changhai Hospital Affiliated to Second Military Medical University
name: Jianping Lu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiology Department, Cancer Hospital Affiliated to Fudan University
name: Weijun Peng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiology Department, Ruijin Hospital Affiliated to Shanghai Jiaotong University, China
name: Fuhua Yan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiology Department, Huashan Hospital, Fudan University, China
name: Xiaoyuan Feng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiology Department, Huadong Hospital Affiliated to Fudan University, China
name: Yanqing Hua, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: