Clinical trial · Observational
Early Detection of Anastomotic Leakage by Microdialysis Catheters
Early Detection of Anastomotic Leakage by Microdialysis Catheters: An Observational Study on Pancreaticoduodenectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas; Fistula | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Fistula | — | UNRESOLVED | — |
| Pancreaticoduodenal; Fistula | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreaticoduodenectomy microdialysis catheter analyses | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pancreaticoduodenectomy patients
- description
- 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
- interventionNames
- Procedure: Pancreaticoduodenectomy microdialysis catheter analyses
Primary outcomes (4)
- measure
- Glycerol concentration postoperatively
- timeFrame
- Measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
- description
- 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
- measure
- Glucose concentration postoperatively
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * \<18 years * patient with tumor which was not resectable
References
Publications (1)
- DERIVEDLindholm 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. PMID 34836755