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

Adenocarcinoma of Head of Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01455610
• Other study ID #: ZMS-001
• Status: Not yet recruiting
• Phase: N/A
• First received: October 18, 2011
• Last updated: October 19, 2011
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2011
• Source: Shanghai Zhongshan Hospital
• Contact: Mengsu Zeng, MD, PhD
• Phone: +86-021-64041990-2130
• Email: zengmengsu[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Head of Pancreas

Locations

Country	Name	City	State
China	Radiology Department, Cancer Hospital, Fuandan University	Shanghai	Shanghai
China	Radiology Department, Changhai Hospital Affiliated to the Second Military Medical University	Shanghai	Shanghai
China	Radiology Department, Huadong Hospital, Fudan University	Shanghai	Shanghai
China	Radiology Department, Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Radiology Department, Ruijing Hospital, Shanghai Jiaotong University	Shanghai	Shanghai
China	Radiology Department, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Meng Su Zeng	Changhai Hospital, Huadong Hospital, Huashan Hospital, Ruijin Hospital, Shanghai Cancer Hospital, China

Country where clinical trial is conducted

China,