Carcinoma, Pancreatic DuctalNCT02451384
According CTC to Compare the Influences of Different Methods to Remove the PDAC
A study testing routine surgery, no-touch surgery and laparoscopic surgery in people with Carcinoma, Pancreatic Ductal and Circulating Tumor Cells, run by Shanghai Zhongshan Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Pancreatic Ductal, Circulating Tumor Cells
- What is being tested?
- routine surgery, no-touch surgery and laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neoplasms with other sites of the pancreas
- With other tumors of any other sites
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Genaral surgery department of Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
W H Lou, PhD, +8618616881868, lou.wenhui@zs-hospital.sh.cn
X F Xu, PhD, +8613061626568, xu.xuefeng@zss-hospital.sh.cn
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, Doctor, liu.tianshu@zs-hospital.sh.cn
Yiyi yu, Master
About this study
Official title: 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.
- Being tested
- routine surgery, no-touch surgery, laparoscopic surgery
- Medical subject headings
- Carcinoma, Pancreatic Ductal, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine surgeryProcedure or surgery
To observe if the surgeries can influence the countings of circulating tumor cells of the patients.
no-touch surgeryProcedure or surgery
laparoscopic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| routine surgery | Experimental | 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. Receives: Procedure: routine surgery |
| no-touch surgery | Experimental | 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. Receives: Procedure: no-touch surgery |
| laparoscopy surgery | Experimental | 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. Receives: Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of CTCs countings between the pre and post-operation in each arm
Measured: 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
Measured: Within 2 weeks after the surgeies are all completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Pancreatic DuctalStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhui Lou, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451384
- Sponsor's protocol ID
- B2015-010
- Status last verified
- Jun 2015
- First submitted
- 14 May 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Influences of Different Methods to Remove the Pancreatic Ductal Adenocarcinoma With the Detection of Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT02451384
- Acronym / sponsor ID
- B2015-010
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| routine surgery | Experimental | Procedure: routine surgeryIn 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. |
| no-touch surgery | Experimental | Procedure: no-touch surgeryIn 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. |
| laparoscopy surgery | Experimental | Procedure: laparoscopic surgeryIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Neoplasms with other sites of the pancreas
- With other tumors of any other sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine surgeryTo observe if the surgeries can influence the countings of circulating tumor cells of the patients. | Procedure or surgery | routine surgery |
| no-touch surgery | Procedure or surgery | no-touch surgery |
| laparoscopic surgery | Procedure or surgery | laparoscopy surgery |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genaral surgery department of Zhongshan Hospital, Fudan University
Shanghai, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine surgery, no-touch surgery and laparoscopic surgery in people with Carcinoma, Pancreatic Ductal and Circulating Tumor Cells, run by Shanghai Zhongshan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.