Pancreatic CancerCOLLECTORNCT02909296
Endoscopic Drainage of Collections After Pancreatic Surgery
An observational study of Pancreatic Cancer, run by Institut Paoli-Calmettes.
Trial summary
The pancreatic surgery causing some pancreatic collections. And in a number of case, this surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage. The endoscopic care of the treatment of pancreatic collections post-surgery is not yet standardized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Endoscopic drainage
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Apr 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically
Who may be able to join
- Age > 18 years
- Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically
Who cannot join
- Contraindication surgery
About this study
The pancreatic surgery causing some pancreatic collections. And in a number of case, this surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage.
The endoscopic care of the treatment of pancreatic collections post-surgery is not yet standardized.
Read more
After failure of the medical treatment, the drainage of collections by echo-endoscopy was described.
There are not much series on this specific subject. Only 2 series contain more than 20 patients with 31 patients for the most important.
The timing and the technical choice of the endoscopic treatment as well as the long-term follow-up are not clear.
The purpose of this study is to estimate the success and the complications of the endoscopic drainage by echo-endoscopy according to the techniques of drainage and the timing of the endoscopic treatment.
The not estimated long-term follow-up will be also considered.
- Conditions
- Pancreatic Cancer
- Being tested
- Endoscopic drainage
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic drainageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term evaluation of the risk of relapse
Measured: Up to 6 month
Timing of endoscopic drainage
Measured: Up to 3 month
Secondary outcomes (1)
Immediate efficiency
Measured: Immediate post operative intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startApr 2007
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAILLOL Fabrice, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909296
- Sponsor's protocol ID
- COLLECTOR
- Acronym
- COLLECTOR
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Drainage of Collections After Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT02909296
- Acronym / sponsor ID
- COLLECTOR / COLLECTOR
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Sep 2016 (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.
The pancreatic surgery causing some pancreatic collections. And in a number of case, this surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage.
The endoscopic care of the treatment of pancreatic collections post-surgery is not yet standardized.
After failure of the medical treatment, the drainage of collections by echo-endoscopy was described.
There are not much series on this specific subject. Only 2 series contain more than 20 patients with 31 patients for the most important.
The timing and the technical choice of the endoscopic treatment as well as the long-term follow-up are not clear.
The purpose of this study is to estimate the success and the complications of the endoscopic drainage by echo-endoscopy according to the techniques of drainage and the timing of the endoscopic treatment.
The not estimated long-term follow-up will be also considered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically
Key inclusion criteria (2 listed)
- Age > 18 years
- Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically
Key exclusion criteria (1 listed)
- Contraindication surgery
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 |
|---|---|---|
| Endoscopic drainage | Procedure or surgery | – |
Primary outcome
Long-term evaluation of the risk of relapse
Time frame: Up to 6 month
Timing of endoscopic drainage
Time frame: Up to 3 month
1 secondary outcome
Immediate efficiency
Time frame: Immediate post operative intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Institut PAOLI-CALMETTESLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
CAILLOL Fabrice, MD principal investigator
Institut Paoli-Calmettes
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Institut Paoli-Calmettes.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term evaluation of the risk of relapse (time frame: Up to 6 month). 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 21 Sep 2016.