Pancreas DiseaseNCT05333991
Endothelial Leakage and the Association to Endothelial Biomarkers After Surgery
An observational study of Pancreas Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The primary aim of this study is to investigate fluid loss from the blood stream (''endothelial leakage'') and the damage on the vessel wall (''endothelial function'') during surgery. Cardiovascular complications during surgery are said to have different causes, e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Disease
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Aug 2022to 1 Nov 2023
- How long will I take part?
- 30 Days
- 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
- Adult, Older adult
Study population: Major abdominal surgery patients will be included. Patients are screened prior to surgery from electronic medical charts. Patients can be co-enrolled in other non-intervention trials. An outline of scheduled study activities is shown in figure one.
Who may be able to join
- Age ≥ 18 years
- Patients are scheduled for Whipple or total pancreatectomy
Who cannot join
- Patient having received immunomodulating treatments less than four weeks prior to surgery
- Patient having other major surgery performed less than four weeks prior to surgery. Thus, minor surgery allowed, for instance minor skin incisions
- Patient having endoscopic retrograde cholangiopancreatography (ERCP) or Percutaneous transhepatic cholangiography (PTC) performed less than two weeks prior to surgery
- Patients scheduled for major vascular surgery during Whipple or total pancreatectomy
- Patient is diagnosed with chronic kidney failure or is in diuretics treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelial Leakage Assessed by 125-I Labeled Serum Albumin and the Association to Endothelial Biomarkers After Major Abdominal Surgery
The primary aim of this study is to investigate fluid loss from the blood stream (''endothelial leakage'') and the damage on the vessel wall (''endothelial function'') during surgery.
Cardiovascular complications during surgery are said to have different causes, e.g. lack of fluid in the blood stream (''hypovolemia'') and decreased vascular tone. Hypovolemia can have different causes, one being damage to the endothelial function. During trauma and infection, it has been previously shown, that damage to the endothelial function causes fluid loss from the blood stream. Nevertheless, this has never been demonstrated during surgery.
Read more
Secondary this study will measure the blood flow using a thermo-camera during surgery. This will together with selected blood tests provide information on various possible causes to hypovolemia.
The purpose of this study is to describe and quantify endothelial damage (assessed by selected endothelial biomarkers) and albumin escape rate as a proxy for endothelial leakage (assessed by measuring radioactive 125-I labeled HSA injected postoperatively), combined with assessment of MTS (assessed by Laser Speckle Contrast Imaging (LSCI) and digital thermography). This will allow a detailed description of the surgery's impact on the endothelial integrity and contribute to a better understanding of the physiological changes that occur postoperatively.
The study will investigate patients undergoing pancreaticoduodenectomy (Whipple) and total pancreatectomy. These patients have a vast clinical need, being one of the most extensive abdominal surgical procedures with great stress response.
The study is a prospective exploratory cohort study and methods include blood sampling pre- and post-operatively, 125-I labeled humane serum albumin postoperatively (and preoperatively if logistically possible) and thermography.
The hypothesis of this study is that the extent of endothelial damage measured by selected biomarkers is associated with the level of albumin escape rate after major abdominal surgery. Secondly, inflammation increases albumin escape rate after major abdominal surgery.
- Conditions
- Pancreas Disease
- Medical subject headings
- Pancreatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Albumin escape rate during the first five postoperative days assessed by intravascular loss of 125-I labeled HSA.
Measured by the use of iod tracer
Measured: five 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 posted19 Apr 2022
- Study start31 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 10 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Taylor Pitter, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333991
- Sponsor's protocol ID
- 2022-RH-iod-tracer
- Status last verified
- Dec 2023
- First submitted
- 12 Apr 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data for all included patients will be available for other selected research colleagues
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Leakage Assessed by 125-I Labeled Serum Albumin and the Association to Endothelial Biomarkers After Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05333991
- Acronym / sponsor ID
- 2022-RH-iod-tracer
- Conditions
- Pancreas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 19 Apr 2022 (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 primary aim of this study is to investigate fluid loss from the blood stream (''endothelial leakage'') and the damage on the vessel wall (''endothelial function'') during surgery.
Cardiovascular complications during surgery are said to have different causes, e.g. lack of fluid in the blood stream (''hypovolemia'') and decreased vascular tone. Hypovolemia can have different causes, one being damage to the endothelial function. During trauma and infection, it has been previously shown, that damage to the endothelial function causes fluid loss from the blood stream. Nevertheless, this has never been demonstrated during surgery.
Secondary this study will measure the blood flow using a thermo-camera during surgery. This will together with selected blood tests provide information on various possible causes to hypovolemia.
The purpose of this study is to describe and quantify endothelial damage (assessed by selected endothelial biomarkers) and albumin escape rate as a proxy for endothelial leakage (assessed by measuring radioactive 125-I labeled HSA injected postoperatively), combined with assessment of MTS (assessed by Laser Speckle Contrast Imaging (LSCI) and digital thermography). This will allow a detailed description of the surgery's impact on the endothelial integrity and contribute to a better understanding of the physiological changes that occur postoperatively.
The study will investigate patients undergoing pancreaticoduodenectomy (Whipple) and total pancreatectomy. These patients have a vast clinical need, being one of the most extensive abdominal surgical procedures with great stress response.
The study is a prospective exploratory cohort study and methods include blood sampling pre- and post-operatively, 125-I labeled humane serum albumin postoperatively (and preoperatively if logistically possible) and thermography.
The hypothesis of this study is that the extent of endothelial damage measured by selected biomarkers is associated with the level of albumin escape rate after major abdominal surgery. Secondly, inflammation increases albumin escape rate after major abdominal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major abdominal surgery patients will be included. Patients are screened prior to surgery from electronic medical charts. Patients can be co-enrolled in other non-intervention trials. An outline of scheduled study activities is shown in figure one.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients are scheduled for Whipple or total pancreatectomy
Key exclusion criteria (5 listed)
- Patient having received immunomodulating treatments less than four weeks prior to surgery
- Patient having other major surgery performed less than four weeks prior to surgery. Thus, minor surgery allowed, for instance minor skin incisions
- Patient having endoscopic retrograde cholangiopancreatography (ERCP) or Percutaneous transhepatic cholangiography (PTC) performed less than two weeks prior to surgery
- Patients scheduled for major vascular surgery during Whipple or total pancreatectomy
- Patient is diagnosed with chronic kidney failure or is in diuretics treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Albumin escape rate during the first five postoperative days assessed by intravascular loss of 125-I labeled HSA.
Time frame: five days after surgery
Measured by the use of iod tracer
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 8 Dec 2023.
- Individual participant dataSharing planned: Yes. The data for all included patients will be available for other selected research colleagues
Related trials for Pancreas Disease
RecruitingObservational study
Pancreatic Cancer Early Detection Consortium
Pancreas Cancer, Pancreas Cyst
Not yet recruitingObservational study
Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)
Pancreas (Including SPK) Transplantation, Pancreas Diseases
RecruitingObservational study
Radiology Registry on Pancreatic Malignancies
Pancreatic Cancer, Pancreas Neoplasm
Not yet recruiting
Intermittent Fasting for Pancreatitis
Pancreatitis, Pancreatitis, Acute
Not yet recruitingObservational study
Development and Prospective Validation of an AI-Based Diagnostic Model for Hepato-Pancreato-Biliary Diseases
Hepatic Disease, Biliary Disease
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?
An observational study of Pancreas Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 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 8 Dec 2023. 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 Denmark. 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?
Albumin escape rate during the first five postoperative days assessed by intravascular loss of 125-I labeled HSA. (time frame: five days after surgery). 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 8 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.