Back to resultsAccording CTC to Compare the Influences of Different Methods to Remove the PDAC
Primary Purpose
Carcinoma, Pancreatic Ductal, Circulating Tumor Cells
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
routine surgery
no-touch surgery
laparoscopic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Pancreatic Ductal
Eligibility 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
Sites / Locations
- Genaral surgery department of Zhongshan Hospital, Fudan University
- Zhongshan Hospital Affiliated to Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
routine surgery
no-touch surgery
laparoscopy surgery
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
the changes of CTCs countings between the pre and post-operation in each arm
the changes of CTCs countings between the pre and post-operation among the arms
Secondary Outcome Measures
Full Information
NCT ID
NCT02451384
First Posted
May 14, 2015
Last Updated
June 28, 2015
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02451384
Brief Title
According CTC to Compare the Influences of Different Methods to Remove the PDAC
Official Title
To Compare the Influences of Different Methods to Remove the Pancreatic Ductal Adenocarcinoma With the Detection of Circulating Tumor Cells
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Pancreatic Ductal, Circulating Tumor Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
routine surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
no-touch surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
laparoscopy surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
routine surgery
Intervention Description
To observe if the surgeries can influence the countings of circulating tumor cells of the patients.
Intervention Type
Procedure
Intervention Name(s)
no-touch surgery
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Genaral surgery department of Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W H Lou, PhD
Phone
+8618616881868
Email
lou.wenhui@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
X F Xu, PhD
Phone
+8613061626568
Email
xu.xuefeng@zss-hospital.sh.cn
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianshu Liu, Doctor
Email
liu.tianshu@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Yiyi yu, Master
12. IPD Sharing Statement
Learn more about this trial
According CTC to Compare the Influences of Different Methods to Remove the PDAC
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