Pancreatic CancerNCT03627559
Early Detection of Anastomotic Leakage by Microdialysis Catheters
An observational study of Pancreatic Cancer and Pancreaticoduodenal; Fistula, run by Oslo University Hospital.
Trial summary
Anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death. Microdialysis catheters can detect focal inflammation and ischemia, and has a potential for early detection of anastomotic leakage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreaticoduodenal; Fistula, Pancreas; Fistula
- What is being tested?
- Pancreaticoduodenectomy microdialysis catheter analyses
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 1 Jul 2018
- 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: Both genders from age 18 and older. Tumor in the head of the pancreas, the bile duct or the duodenum. Planned to undergo pancreaticoduodencetomy
Who may be able to join
- Tumor in the head of the pancreas, the bile duct or the duodenum detected on a computed tomography (CT) scan or magnetic resonance imaging (MRI), and evaluated by a multidisciplinary team to be resectable with a pancreaticoduodenectomy.
- Written informed consent was obtained before study enrollment.
Who cannot join
- <18 years
- patient with tumor which was not resectable
About this study
Official title: Early Detection of Anastomotic Leakage by Microdialysis Catheters: An Observational Study on Pancreaticoduodenectomy
Anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death. Microdialysis catheters can detect focal inflammation and ischemia, and has a potential for early detection of anastomotic leakage. This observational study will examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.
Read the detailed description
Pancreaticoduodenectomy (Whipple´s procedure) offers the only potential cure for patients with tumor in the head of the pancreas, bile duct or periampullary region. This procedure is associated with high perioperative and postoperative mortality and morbidity. Postoperative pancreatic fistulae (POPF) is the most feared complication, and is often discovered with significant delay resulting in development of organ dysfunction and sepsis. Current standard for clinical detection of POPF is limited and nonspecific.
Microdialysis catheters allow bedside measurements of metabolism such as lactate, pyruvate, glucose and glycerol. The method has a high sensitivity and specificity in detecting complications in several types of abdominal surgery. However, microdialysis used after pancreaticoduodenectomy is not well documented. This observational study examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.
- Being tested
- Pancreaticoduodenectomy microdialysis catheter analyses
- Keywords
- Pancreaticoduodenectomy, Pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms, Fistula, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticoduodenectomy microdialysis catheter analysesProcedure or surgery
A thin microdialysis catheter is implanted before skin closure after pancreaticoduodenectomy. Analyses of the microdialysate are done at certain timepoints postoperatively. No intervention is done based on the results. The patients are following standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Pancreaticoduodenectomy patients | All patients undergoing pancreaticoduodenectomy receive a microdialysis catheter before skin closure and will be monitored postoperatively for lactate, pyruvate, glucose and glycerol in the microdialysate at certain timepoints Receives: Procedure: Pancreaticoduodenectomy microdialysis catheter analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycerol concentration postoperatively
Glycerol concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Measured: Measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Glucose concentration postoperatively
Glucose concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Measured: Measured hourly after surgery during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Lactate concentration postoperatively
Lactate concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Measured: Measured hourly after surgery during the first 24 hours after surgery and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Pyruvate concentration postoperatively
Pyruvate concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Measured: Measured hourly after surgery during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 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 posted13 Aug 2018
- Study start1 Oct 2013
- Primary completion31 Mar 2014
- Study completion1 Jul 2018
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 CancerStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Espen Lindholm, Oslo University Hospital
- Investigators
- Espen Lindholm, ph.d, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627559
- Sponsor's protocol ID
- 2012/143
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for share IPD
Publications
Lindholm E, Bergmann GB, Haugaa H, Labori KJ, Yaqub S, Bjornbeth BA, Line PD, Grindheim G, Kjosen G, Pischke SE, Tonnessen TI. Early detection of anastomotic leakage after pancreatoduodenectomy with microdialysis catheters: an observational Study. HPB (Oxford). 2022 Jun;24(6):901-909. doi: 10.1016/j.hpb.2021.10.020. Epub 2021 Nov 5.
PubMed 34836755
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Anastomotic Leakage by Microdialysis Catheters: An Observational Study on Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT03627559
- Acronym / sponsor ID
- 2012/143
- Keywords
- Pancreaticoduodenectomy, Pancreatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 13 Aug 2018 (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.
Anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death. Microdialysis catheters can detect focal inflammation and ischemia, and has a potential for early detection of anastomotic leakage. This observational study will examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.
Detailed description
Pancreaticoduodenectomy (Whipple´s procedure) offers the only potential cure for patients with tumor in the head of the pancreas, bile duct or periampullary region. This procedure is associated with high perioperative and postoperative mortality and morbidity. Postoperative pancreatic fistulae (POPF) is the most feared complication, and is often discovered with significant delay resulting in development of organ dysfunction and sepsis. Current standard for clinical detection of POPF is limited and nonspecific.
Microdialysis catheters allow bedside measurements of metabolism such as lactate, pyruvate, glucose and glycerol. The method has a high sensitivity and specificity in detecting complications in several types of abdominal surgery. However, microdialysis used after pancreaticoduodenectomy is not well documented. This observational study examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreaticoduodenectomy patients | – | Procedure: Pancreaticoduodenectomy microdialysis catheter analysesAll patients undergoing pancreaticoduodenectomy receive a microdialysis catheter before skin closure and will be monitored postoperatively for lactate, pyruvate, glucose and glycerol in the microdialysate at certain timepoints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both genders from age 18 and older. Tumor in the head of the pancreas, the bile duct or the duodenum. Planned to undergo pancreaticoduodencetomy
Key inclusion criteria (2 listed)
- Tumor in the head of the pancreas, the bile duct or the duodenum detected on a computed tomography (CT) scan or magnetic resonance imaging (MRI), and evaluated by a multidisciplinary team to be resectable with a pancreaticoduodenectomy.
- Written informed consent was obtained before study enrollment.
Key exclusion criteria (2 listed)
- <18 years
- patient with tumor which was not resectable
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 |
|---|---|---|
| Pancreaticoduodenectomy microdialysis catheter analysesA thin microdialysis catheter is implanted before skin closure after pancreaticoduodenectomy. Analyses of the microdialysate are done at certain timepoints postoperatively. No intervention is done based on the results. The patients are following standard of care. | Procedure or surgery | Pancreaticoduodenectomy patients |
Primary outcome
Glycerol concentration postoperatively
Time frame: Measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Glycerol concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Glucose concentration postoperatively
Time frame: Measured hourly after surgery during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Glucose concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Lactate concentration postoperatively
Time frame: Measured hourly after surgery during the first 24 hours after surgery and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Lactate concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Pyruvate concentration postoperatively
Time frame: Measured hourly after surgery during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Pyruvate concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
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 13 Aug 2018.
- Derived from this study: PubMed 34836755Lindholm E, Bergmann GB, Haugaa H, Labori KJ, Yaqub S, Bjornbeth BA, Line PD, Grindheim G, Kjosen G, Pischke SE, Tonnessen TI. Early detection of anastomotic leakage after pancreatoduodenectomy with microdialysis catheters: an observational Study. HPB (Oxford). 2022 Jun;24(6):901-909. doi: 10.1016/j.hpb.2021.10.020. Epub 2021 Nov 5.
- Individual participant dataSharing planned: No. No plan for share IPD
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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.
Espen Lindholm, ph.d principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Pancreaticoduodenal; Fistula, run by Oslo University Hospital.
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 2 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 13 Aug 2018. 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?
Glycerol concentration postoperatively (time frame: Measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery). The study lists 4 primary outcomes in all. 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 NCT03627559, 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 13 Aug 2018.