Postoperative ComplicationsPhase 2NCT01460615
Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection
A Phase 2 study testing Hydrocortisone in people with Postoperative Complications and Postoperative Pancreatitis, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Postoperative Pancreatitis
- What is being tested?
- Hydrocortisone
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Feb 2011to Jan 2017
- Phase
- Phase 2
- 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
- Adult, Older adult
Who may be able to join
- Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital
Who cannot join
- Patients with an ongoing cortisone treatment
- Cefuroxime allergy
- Chronic pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).
- Being tested
- Hydrocortisone
- Keywords
- Postoperative pancreatitis, Postoperative complications, Delayed gastric emptying, Leakage, Fistula, Acinar cell, Risk patient, Pancreaticoduodenectomy, Whipple, Cortisone
- Medical subject headings
- Postoperative Complications, Gastroparesis, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative overall complications of pancreatic resection
e.g. Postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, biliary fistula, wound infection, postoperative pancreatitis.
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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 2
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460615
- Sponsor's protocol ID
- R11009M
- Status last verified
- Oct 2011
- First submitted
- 25 Oct 2011
- Last updated
- 29 Nov 2018
- Results posted
- No
Publications
Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702. doi: 10.1097/SLA.0000000000001883.
PubMed 27429037
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection
- ClinicalTrials.gov ID
- NCT01460615
- Acronym / sponsor ID
- R11009M
- Keywords
- Postoperative pancreatitis, Postoperative complications, Delayed gastric emptying, Leakage, Fistula, Acinar cell, Risk patient, Pancreaticoduodenectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Oct 2011 (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 purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital
Key exclusion criteria (3 listed)
- Patients with an ongoing cortisone treatment
- Cefuroxime allergy
- Chronic pancreatitis
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 |
|---|---|---|
| Hydrocortisone | Drug | – |
Primary outcome
Postoperative overall complications of pancreatic resection
Time frame: within the first 30 days after surgery
e.g. Postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, biliary fistula, wound infection, postoperative pancreatitis.
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 29 Nov 2018.
- Derived from this study: PubMed 27429037Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702. doi: 10.1097/SLA.0000000000001883.
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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 Phase 2 study testing Hydrocortisone in people with Postoperative Complications and Postoperative Pancreatitis, 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 1 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: finished, as of the sponsor's last update on 29 Nov 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative overall complications of pancreatic resection (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01460615, which also lists 1 linked publication.
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 29 Nov 2018.