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

June 28, 2015 updated by: Wenhui Lou, Shanghai Zhongshan Hospital

To Compare the Influences of Different Methods to Remove the Pancreatic Ductal Adenocarcinoma With the Detection of Circulating Tumor Cells

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
      • Shanghai, Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 1 week after the surgeries are completed in any arm
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
Within 2 weeks after the surgeies are all completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (ESTIMATE)

May 22, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 28, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2015-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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