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According CTC to Compare the Influences of Different Methods to Remove the PDAC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02451384
Recruitment Status : Unknown
Verified June 2015 by Wenhui Lou, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : May 22, 2015
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Wenhui Lou, Shanghai Zhongshan Hospital

Brief Summary:
Acccording circulating tumor cells to compare the differences of different methods(routine method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of pancreatic body and tail.

Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Circulating Tumor Cells Procedure: routine surgery Procedure: no-touch surgery Procedure: laparoscopic surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Compare the Influences of Different Methods to Remove the Pancreatic Ductal Adenocarcinoma With the Detection of Circulating Tumor Cells
Study Start Date : June 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: routine surgery
In this arm the patients will be performed routine surgery to remove the tumors. And then we compare their circulating tumor cell countings in the pre and post-operation.
Procedure: routine surgery
To observe if the surgeries can influence the countings of circulating tumor cells of the patients.

Experimental: no-touch surgery
In this arm the patients will be performed no-touch surgery to remove the tumors. And then we compare their circulating tumor cells countings in the pre and post-operation.
Procedure: no-touch surgery
Experimental: laparoscopy surgery
In this arm the patients will be performed laparoscopy surgery to remove the tumors. And then we compare their circulating tumor cells countings in the pre and post-operation.
Procedure: laparoscopic surgery



Primary Outcome Measures :
  1. the changes of CTCs countings between the pre and post-operation in each arm [ Time Frame: Within 1 week after the surgeries are completed in any arm ]
  2. the changes of CTCs countings between the pre and post-operation among the arms [ Time Frame: Within 2 weeks after the surgeies are all completed ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ductal adenocarcinoma of pancreatic body and tail
  • Tumor can be removed
  • No other tumors and without liver metastases
  • Age from 18 to 80 years old

Exclusion Criteria:

  • Neoplasms with other sites of the pancreas
  • With other tumors of any other sites

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451384


Locations
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China, Shanghai
Genaral surgery department of Zhongshan Hospital, Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: W H Lou, PhD    +8618616881868    lou.wenhui@zs-hospital.sh.cn   
Contact: X F Xu, PhD    +8613061626568    xu.xuefeng@zss-hospital.sh.cn   
Zhongshan Hospital Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Tianshu Liu, Doctor       liu.tianshu@zs-hospital.sh.cn   
Sub-Investigator: Yiyi yu, Master         
Sponsors and Collaborators
Shanghai Zhongshan Hospital

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Responsible Party: Wenhui Lou, Associate Professor of General Surgery Department, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02451384    
Other Study ID Numbers: B2015-010
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Carcinoma, Pancreatic Ductal
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases