Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

NCT ID: NCT01455610

Last Updated: 2011-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adenocarcinoma of Head of Pancreas

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role collaborator

Shanghai Cancer Hospital, China

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Huadong Hospital

OTHER

Sponsor Role collaborator

Meng Su Zeng

OTHER

Sponsor Role lead

Responsible Party

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Meng Su Zeng

Mengsu Zeng, MD & Ph.D,Chairman & Professor,Department of Radiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mengsu Zeng, MD, PhD

Role: STUDY_CHAIR

Radiology Department, Zhongshan Hospital of Fudan University

Jianping Lu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Radiology Department, Changhai Hospital Affiliated to Second Military Medical University

Weijun Peng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radiology Department, Cancer Hospital Affiliated to Fudan University

Fuhua Yan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radiology Department, Ruijin Hospital Affiliated to Shanghai Jiaotong University, China

Xiaoyuan Feng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radiology Department, Huashan Hospital, Fudan University, China

Yanqing Hua, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radiology Department, Huadong Hospital Affiliated to Fudan University, China

Locations

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Radiology Department, Ruijing Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status

Radiology Department, Cancer Hospital, Fuandan University

Shanghai, Shanghai Municipality, China

Site Status

Radiology Department, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Radiology Department, Huadong Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Radiology Department, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Radiology Department, Changhai Hospital Affiliated to the Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Mengsu Zeng, MD, PhD

Role: CONTACT

+86-021-64041990-2130

Xiuzhong Yao, MD, PhD

Role: CONTACT

+86-021-64041990-5425

Facility Contacts

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Fuhua Yan, MD, PhD

Role: primary

+86-13764236797

Weijun Peng, Md, PhD

Role: primary

+86-13564682870

Mengsu Zeng, MD, PhD

Role: primary

+86-021-64041990-2130

Yanqing Hua, MD, PhD

Role: primary

+86-13774234090

Xiaoyuan Feng, MD, PhD

Role: primary

+86-13601659304

Jianping Lu, MD, PhD

Role: primary

+86-13701775219

Other Identifiers

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ZMS-001

Identifier Type: -

Identifier Source: org_study_id