Distal Pancreatic ResectionsNCT02113046
Pancreatic Stump Closure After Distal Pancreatic Resection
A study testing pancreatico-jejunal anastomosis and traditional anastomosis in people with Distal Pancreatic Resections, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Distal Pancreatic Resections
- What is being tested?
- pancreatico-jejunal anastomosis and traditional anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2009to Jul 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patiens which the distal pancreatic resektions
- the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis
Who cannot join
- if the pancreas is not suitable for this kind of anastomosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study to Decrease Pancreatic Fistula Rate
The aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy.
- Conditions
- Distal Pancreatic Resections
- Being tested
- pancreatico-jejunal anastomosis, traditional anastomosis
- Keywords
- pancreas, pancreatico-jejunal anastomosis, postoperative pancreatic fistulae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatico-jejunal anastomosisProcedure or surgery
traditional anastomosisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| pancreatico-jejunal anastomosis | Active comparator | patients in which the finnish binding pancreatico-jejunal anastomosis is techically possible to perfom during distal pancreatic resektion Receives: Procedure: pancreatico-jejunal anastomosis |
| traditional anastomosis | Active comparator | pancreatic resections with traditional stump closure Receives: Procedure: traditional anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pancreatic fistula rata
Measured: 30 days
Secondary outcomes (1)
Number of patients with resection margin on the left side of portal vein as a measure of feasibility.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startOct 2009
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: interim analysis does not show good results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Pancreatic ResectionsStudies of the same condition, open and under way.
- More trials run by Tampere University 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Antila, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113046
- Sponsor's protocol ID
- R09131
- Status last verified
- Apr 2014
- First submitted
- 26 Mar 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Decrease Pancreatic Fistula Rate
- ClinicalTrials.gov ID
- NCT02113046
- Acronym / sponsor ID
- R09131
- Conditions
- Distal Pancreatic Resections
- Keywords
- pancreas, pancreatico-jejunal anastomosis, postoperative pancreatic fistulae
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis does not show good results
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Apr 2014 (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 aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pancreatico-jejunal anastomosis | Active comparator | Procedure: pancreatico-jejunal anastomosispatients in which the finnish binding pancreatico-jejunal anastomosis is techically possible to perfom during distal pancreatic resektion |
| traditional anastomosis | Active comparator | Procedure: traditional anastomosispancreatic resections with traditional stump closure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patiens which the distal pancreatic resektions
- the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis
Key exclusion criteria (1 listed)
- if the pancreas is not suitable for this kind of anastomosis
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 |
|---|---|---|
| pancreatico-jejunal anastomosis | Procedure or surgery | pancreatico-jejunal anastomosis |
| traditional anastomosis | Procedure or surgery | traditional anastomosis |
Primary outcome
postoperative pancreatic fistula rata
Time frame: 30 days
1 secondary outcome
Number of patients with resection margin on the left side of portal vein as a measure of feasibility.
Time frame: 30 days
Results and safety
The study was stopped early (reason given: interim analysis does not show good results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreatico-jejunal anastomosis and traditional anastomosis in people with Distal Pancreatic Resections, run by Tampere University Hospital at 1 site in Finland.
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: stopped early, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
The study was stopped early (reason given: interim analysis does not show good results). Results are not available in the source record.
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?
postoperative pancreatic fistula rata (time frame: 30 days). 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 14 Apr 2014.