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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oslo University Hospital
Coordinator of this site? Confirm its status
OsloNorwayUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.