Healing Time of Post Operative Pancreatic FistulasNCT02220010
Does Post Operative Pancreatic Fistula, After Left Sided Resections, Heal Faster After the Introduction of a Pancreatic Stent?
A study testing Pancreatic stent in people with Healing Time of Post Operative Pancreatic Fistulas, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healing Time of Post Operative Pancreatic Fistulas
- What is being tested?
- Pancreatic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2014to Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Left sided or distal pancreatic resection
- Grade B or C fistula on postoperative day 3 or later
Who cannot join
- Do not want to participate in study
- Can not read patient information in swedish
- The papilla can not be endoscopically reached
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dep of Surgical Gastroenterology, Karolinska University Hospital
Stockholm, SE-141 86
John Blomberg, MD, PhD, +46(0)703983060, john.blomberg@karolinska.se
Christoph Ansorge, MD, PhD, christoph.ansorge@karolinska.se
About this study
Official title: Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial
Dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage reduces healing time. A pancreatic stent could theoretically improve the drainage of pancreatic juice into the duodenum and by this shorten the healing time still further.
Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not shown a positive effect on fistula formation.
In an open randomized multicenter clinical trial we want to test the hypothesis that a reduced fistula healing time, in left sided pancreatic resections, could be reduced by introducing a pancreatic stent when on post operative day 3 or later a B och C fistula (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by randomizing between pancreatic stent with drains versus only drains.
- Being tested
- Pancreatic stent
- Keywords
- Post operative pancreatic fistulas, Pancreatic stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic stentDevice
Also called Pancreatic duct stent (made of plastic material)
The plastic stent is introduced in the pancreatic duct by a duodenoscope
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic stent | Experimental | If POPF grade B or C is detected on post operative day 3 or more, a pancreatic stent is endoscopically positioned in the pancreatic duct. Receives: Device: Pancreatic stent |
| Drain only | No intervention | If POPF grade B or C is detected on post operative day 3 or more, only the per-operatively placed drain is used as treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
POPF healing time (days)
Post operative pancreatic fistula(POPF) and grade (A,B,C) is diagnosed according to ISGPF on post operative day 3 or later if the pancrease-amylase concentration is more than three times the upper limit of the normal plasma concentration of pancreas-amylase. When the drain fluid concentration is below this value the fistula is defined as healed.
Measured: 12 days (median hospital stay)
Secondary outcomes (1)
POPF grade (A,B,C)
International Study Group on Pancreatic Fistula (ISGPF) (Bassi et al 2005)defines fistula grade A-C. Grade A is leakage of pancreatic juice with a concentration of more than 3 times the upper normal level in plasma but no other clinical implication for the patient. If an inflammatory response is seen, but not sepsis, it is graded as B fistula and if sepsis occurs and/or single- or multi-organ dysfunction is seen it is graded as C.
Measured: 12 days (median hospital stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing Time of Post Operative Pancreatic FistulasStudies of the same condition, open and under way.
- More trials run by Karolinska 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Lund University Hospital, University Hospital, Linkoeping, Norrlands University Hospital
- Responsible party
- Principal investigator, John Blomberg, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220010
- Sponsor's protocol ID
- POPF and stenting-002
- Status last verified
- Aug 2014
- First submitted
- 18 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial
- ClinicalTrials.gov ID
- NCT02220010
- Acronym / sponsor ID
- POPF and stenting-002
- Keywords
- Post operative pancreatic fistulas, Pancreatic stenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Lund University Hospital, University Hospital, Linkoeping, Norrlands University Hospital
- Study start
- Jun 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 19 Aug 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.
Dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage reduces healing time. A pancreatic stent could theoretically improve the drainage of pancreatic juice into the duodenum and by this shorten the healing time still further.
Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not shown a positive effect on fistula formation.
In an open randomized multicenter clinical trial we want to test the hypothesis that a reduced fistula healing time, in left sided pancreatic resections, could be reduced by introducing a pancreatic stent when on post operative day 3 or later a B och C fistula (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by randomizing between pancreatic stent with drains versus only drains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic stent | Experimental | Device: Pancreatic stentIf POPF grade B or C is detected on post operative day 3 or more, a pancreatic stent is endoscopically positioned in the pancreatic duct. |
| Drain only | No intervention | –If POPF grade B or C is detected on post operative day 3 or more, only the per-operatively placed drain is used as treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Left sided or distal pancreatic resection
- Grade B or C fistula on postoperative day 3 or later
Key exclusion criteria (3 listed)
- Do not want to participate in study
- Can not read patient information in swedish
- The papilla can not be endoscopically reached
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 |
|---|---|---|
| Pancreatic stentAlso: Pancreatic duct stent (made of plastic material)The plastic stent is introduced in the pancreatic duct by a duodenoscope | Device | Pancreatic stent |
Primary outcome
POPF healing time (days)
Time frame: 12 days (median hospital stay)
Post operative pancreatic fistula(POPF) and grade (A,B,C) is diagnosed according to ISGPF on post operative day 3 or later if the pancrease-amylase concentration is more than three times the upper limit of the normal plasma concentration of pancreas-amylase. When the drain fluid concentration is below this value the fistula is defined as healed.
1 secondary outcome
POPF grade (A,B,C)
Time frame: 12 days (median hospital stay)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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.
Dep of Surgical Gastroenterology, Karolinska University Hospital
Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic stent in people with Healing Time of Post Operative Pancreatic Fistulas, run by Karolinska University Hospital at 1 site in Sweden.
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 3 inclusion and 3 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 19 Aug 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 Sweden. 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?
POPF healing time (days) (time frame: 12 days (median hospital stay)). 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 19 Aug 2014; AzTrials last refreshed its copy on 6 Nov 2026.