NCT03631173Active, not recruiting
Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy
Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy - a Randomized Controlled Trial. THE MINIMUM STUDY
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
A pancreaticoduodenectomy is performed in patient with pancreatic cancer. The most common and serious complication is leakage between the intestine and the remnant pancreas after this procedure. It occurs in 20-30%. The result is often prolonged hospital and ICU stay, reoperations and deaths (3-5%). To detect a leakage early before the patient becomes seriously ill, thereby initiating treatment is therefore very important. By inserting a thin microdialysis catheter near the anastomosis between pancreas and intestine before closure of the abdominal wall, the investigators will analyze substances such as lactic acid, pyruvate, glycerol, etc. and if these substances may reveal anastomosis leakage at an early stage. Observational studies have shown that if a leakage occurs, glycerol concentration in the microdialysate will rise significant after few hours, and changes in lactic acid and pyruvate values will change as a sign of inflammation. The investigators want to conduct a randomized study comparing patients undergoing pancreaticoduodenectomy and using microdialysis in half of the included population.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 201 (actual)
- First submitted
- 9 Jul 2018
- Start date
- 2 Apr 2019
- Primary completion date
- 1 Aug 2021
- Lead sponsor
- Oslo University Hospital
- NCT number
- NCT03631173
What you commit to
- Study type: Interventional
- Participants enrolled: 201
- From 2 Apr 2019 to the primary completion date, 1 Aug 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergic to Voluven® (Fresenius Kabi AS, Halden, Norway) and contrast given during CT scan
Other
- Another study interfering with current study
- Pregnant
Who the study is looking for
- Patients must be scheduled for a pancreaticoduodenectomy
- Subject must be ≥ 18 years
- Able to give written signed informed consent
- Investigator's assessment that the patient is able to understand, comply and follow the instructions needed to successfully participate in this trial
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.