Pancreatic DiseasesNCT04668781
Improvement of Care of Patients Undergoing Pancreaticoduodenectomy
A study testing Analgesia via epidural catheter and Analgesia via wound catheter in people with Pancreatic Diseases and Pancreas Cancer, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Diseases, Pancreas Cancer
- What is being tested?
- Analgesia via epidural catheter and Analgesia via wound catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFinland
- Study dates
- 21 Dec 2020to 18 Dec 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or over
- patients who undergo pancreaticoduodenectomy
Who cannot join
- patients to whom are made a major vascular reconstruction
- patients with significant comorbidities and inability to use PCA
- regural use of strong opioids or drugs preoperatively
- patients with severe chronic pain issues
- chronic atrial fibrillation
- patients who refuse to take part to the study
Trial locations and contacts
1 site in 1 country.
About this study
The study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. The aim of the study is to examine whether there are a difference in perioperative fluid therapy and complication rates between the patients in epidural and wound catheter groups.
Read the detailed description
All patients undergoing pancreaticoduodenectomy in Helsinki University Hospital are recruited in the study. Patients meeting the inclusion criteria and giving consent to participate the study will be randomised to whether epidural analgesia group or wound catheter analgesia group. Both groups receive additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).
- Conditions
- Pancreatic Diseases, Pancreas Cancer
- Being tested
- Analgesia via epidural catheter, Analgesia via wound catheter
- Keywords
- pancreaticoduodenectomy, fluid therapy, enhanced recovery after surgery (ERAS), postoperative complications
- Medical subject headings
- Pancreatic Diseases, Pancreatic Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia via epidural catheterProcedure or surgery
Ropivacain-infusion 2 mg/ml 1,25ml/h/10kg IBW (ideal body weight) is started to patients in the beginning of the surgery and is continued to POD 4. The rest of the treatment obey study protocol in both groups.
Analgesia via wound catheterProcedure or surgery
Ropivacain 5 mg/ml 2,5ml/10kg IBW (ideal body weight) is given to patients in the end of the surgery. After that ropivacain-infusion 2mg/ml 1,25ml/h/10kg IBW is started to patients and is continued to POD 4. The rest of the treatment obey study protocol in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Active comparator | Not described Receives: Procedure: Analgesia via epidural catheter |
| Wound catheter analgesia | Experimental | Not described Receives: Procedure: Analgesia via wound catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The norepinephrine consumption
Norepinephrine consumption on POD 0
Measured: Postoperative day 0
Secondary outcomes (7)
Fluid volumes on PODs 0-4
Intraoperative and postoperative fluid volumes
Measured: Postoperative days 0-4
Oxycodone consumption
Intravenous PCA opioid consumption.
Measured: Postoperative days 1-4
Hospital length of stay
Measured: Postoperative days 0-60
Postoperative complications
Clavien-Dindo complications (scale 0-5), pancreatic fistulas (ISGPF definition, grade A-C), postpancreatectomy hemorrage (IPGPS definition, grade A-C), delayed gastric emptying (ISGPS definition, grade A-C).
Measured: Postoperative days 0-90
Reoperation rates
Measured: Postoperative days 0-90
Readmission rates
Measured: Postoperative days 0-90
Mortality
Measured: postoperative day 0-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start21 Dec 2020
- Primary completion18 Sep 2024
- Study completion18 Dec 2024
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 Pancreatic DiseasesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Piia Peltoniemi, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668781
- Sponsor's protocol ID
- 3169/2018
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2020
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peltoniemi PM, Nieminen TM, Belfrage HIS, Ylikoski EK, Kokkola AJ, Koivunen RI, Mustonen HK, Pere PJ, Seppanen HE. Impact of epidural versus wound catheter analgesia for patients undergoing open pancreatoduodenectomy: A randomized controlled trial. Pancreatology. 2026 Jul 7:S1424-3903(26)00231-0. doi: 10.1016/j.pan.2026.07.003. Online ahead of print.
PubMed 42436052
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Care of Patients Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT04668781
- Acronym / sponsor ID
- 3169/2018
- Conditions
- Pancreatic Diseases, Pancreas Cancer
- Keywords
- pancreaticoduodenectomy, fluid therapy, enhanced recovery after surgery (ERAS), postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 16 Dec 2020 (actual)
- 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 study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. The aim of the study is to examine whether there are a difference in perioperative fluid therapy and complication rates between the patients in epidural and wound catheter groups.
Detailed description
All patients undergoing pancreaticoduodenectomy in Helsinki University Hospital are recruited in the study. Patients meeting the inclusion criteria and giving consent to participate the study will be randomised to whether epidural analgesia group or wound catheter analgesia group. Both groups receive additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | Active comparator | Procedure: Analgesia via epidural catheter |
| Wound catheter analgesia | Experimental | Procedure: Analgesia via wound catheter |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 years or over
- patients who undergo pancreaticoduodenectomy
Key exclusion criteria (6 listed)
- patients to whom are made a major vascular reconstruction
- patients with significant comorbidities and inability to use PCA
- regural use of strong opioids or drugs preoperatively
- patients with severe chronic pain issues
- chronic atrial fibrillation
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 |
|---|---|---|
| Analgesia via epidural catheterRopivacain-infusion 2 mg/ml 1,25ml/h/10kg IBW (ideal body weight) is started to patients in the beginning of the surgery and is continued to POD 4. The rest of the treatment obey study protocol in both groups. | Procedure or surgery | Epidural analgesia |
| Analgesia via wound catheterRopivacain 5 mg/ml 2,5ml/10kg IBW (ideal body weight) is given to patients in the end of the surgery. After that ropivacain-infusion 2mg/ml 1,25ml/h/10kg IBW is started to patients and is continued to POD 4. The rest of the treatment obey study protocol in both groups. | Procedure or surgery | Wound catheter analgesia |
Primary outcome
The norepinephrine consumption
Time frame: Postoperative day 0
Norepinephrine consumption on POD 0
7 secondary outcomes
Fluid volumes on PODs 0-4
Time frame: Postoperative days 0-4
Oxycodone consumption
Time frame: Postoperative days 1-4
Hospital length of stay
Time frame: Postoperative days 0-60
Postoperative complications
Time frame: Postoperative days 0-90
Reoperation rates
Time frame: Postoperative days 0-90
Readmission rates
Time frame: Postoperative days 0-90
Mortality
Time frame: postoperative day 0-90
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 14 Mar 2025.
- Derived from this study: PubMed 42436052Peltoniemi PM, Nieminen TM, Belfrage HIS, Ylikoski EK, Kokkola AJ, Koivunen RI, Mustonen HK, Pere PJ, Seppanen HE. Impact of epidural versus wound catheter analgesia for patients undergoing open pancreatoduodenectomy: A randomized controlled trial. Pancreatology. 2026 Jul 7:S1424-3903(26)00231-0. doi: 10.1016/j.pan.2026.07.003. Online ahead of print.
- 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.
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 Analgesia via epidural catheter and Analgesia via wound catheter in people with Pancreatic Diseases and Pancreas Cancer, run by Helsinki University Central 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 6 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 14 Mar 2025. 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 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?
The norepinephrine consumption (time frame: Postoperative day 0). 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 NCT04668781, 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 14 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.