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

Pancreatic Cancer

Pancreaticoduodenal; Fistula

Pancreas; Fistula

Pancreatic Fistula

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.

Pancreaticoduodenectomy microdialysis catheter analyses

Early Detection of Anastomotic Leakage by Microdialysis Catheters

Early Detection of Anastomotic Leakage by Microdialysis Catheters: An Observational Study on Pancreaticoduodenectomy

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 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 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 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

Espen Lindholm

senior Researcher

Oslo University Hospital

15 patients with type 2 diabetes mellitus with periodontal endodontic lesions

15 non-diabetics with periodontal endodontic lesions

Diabetes

Candida Albicans in Periodontal and Endodontic Lesions in Diabetic and Normoglycemic Patients

Investigations of the Prevalence and Virulence of Candida Albicans in Periodontal and Endodontic Lesions in Diabetic and Normoglycemic Patients

Collection from the root canal was performed after access, rubber dam isolation, disinfection of the surgical field with 5.25% sodium hypochlorite, and neutralization with 5% sodium thiosulfato, with 3 sterile paper points remaining in the root canal for one minute.

Sampling of the periodontal pocket was made at the deepest site through 3 sterile paper points, inserted one by one for one minute. The material collected from the periodontal pocket and the root canal was inoculated in Eppendorf tubes containing 1 ml of reduced transport fluid (RTF).

Universidade Federal Fluminense

This is a prospective, single cohort observational study, aimed at using a historical control group as comparison. It will be conducted at our single, national centre for organ transplantation in Oslo. All pancreas recipients > 18 years of age, who fulfill the inclusion criteria, will prior to transplantation be asked for inclusion.

Blood samples will be obtained at the time of Tx and later scheduled time points to: - Study of immune cell activation (CD25, FOXP3, CD4, CD3, CD8, CD45RO, perforin, granzyme A/B, etc) and cytokines (IL-2, IL-12 etc) - Compare biomarkers in serum, indicative of acute rejection; RNA microarray on a series of genes related to rejection, quantitative PCR on selected genes) Scheduled biopsies will be taken according to our present routine protocol at 3 wks, 6 wks and 12 mts post-Tx, as well as indication biopsies; simultaneosly from these four transplant/organ sources: Pancreas-Tx (P); Kidney-Tx (K); Duodenal segment of pancreas-Tx (tD; Native Duodenum (control) Histological and molecular evaluations will involve: - Rejection histology scores - Immunoshistochemistry on immunologic markers (CD25, FOXP3, CD4, CD3, CD8, CD45RO, perforin, granzyme A/B, etc) - DNA/RNA analyses on immunologic markers: PCR, RNA microarray

Diabetes Mellitus

Pancreas Transplantation

Allograft Rejection

Surgical Complication Nec

Allograft Biopsies

The Norwegian Pancreas Transplantation (PTx) Study

A Prospective, Observational Study in Pancreatic Allograft Recipients: The Effect of Risk Factors, Immunosuppressive Level and the Benefits of Scheduled Biopsies - on Surgical Complications, Rejections and Graft Survival

Compare the incidence of acute rejection episodes at 6, 12, 36 and 60 months after pancreas transplantation, between our single prospective cohort with lower CS vs a historic, retrospective control group (PTx performed during 2011-2013). The incidence of rejection is defined as the fraction of patients in which rejections episodes (one or more) have been proven by biopsies. For SPK rejection in either organ, pancreas or kidney, counts.
Furthermore, we will compare the number and severity of rejection episodes in the pancreas allograft to the ones occurring in the kidney allograft (SPK), and the ones diagnosed by the duodenal segment biopsies.

Compare the incidence of surgical complications, involving reoperations and reinterventions, between the prospective study cohort and retrospective control group.

Record kidney (and pancreas) graft survival (SPK) 12, 36 and 60 months post-Tx

Compare patient survival at 12, 36 and 60 months post-Tx.

Compare the incidence of non-surgical complications; infections, cardial complications, pulmonary complications and neurological complications.

Blood samples will be obtained at the time of transplantation and later scheduled time points:
Study of immune cell activation (CD25, FOXP3, CD4, CD3, CD8, CD45RO, perforin, granzyme A/B, etc) and cytokines (IL-2, TNF-a, IFN-g, IL-10, IL-12 etc).
Compare biomarkers in serum, indicative of acute rejection, by at least weekly blood sampling post-Tx (RNA microarray on a series of genes related to rejection, quantitative PCR on selected genes)
Study Pancreas Auto-antibodies

Scheduled biopsies will be taken at 3 wks, 6 wks and 12 mts post-Tx; as well as indication biopsies, simultaneously from these four transplant/organ sources: Pancreas-Tx (P); Kidney-Tx (K); Duodenal segment of pancreas-Tx (tD); Native Duodenum (nD; serves as control)
Immunohistochemistry on immunologic markers (CD25, FOXP3, CD4, CD3, CD8, CD45RO, perforin, granzyme A/B, etc)
DNA/RNA- analyses on immunologic markers; PCR, RNA microarray

During upper endoscopy for scheduled biopsies of the pancreas and duodenal segment (at 3 wks, 6 wks and 12 mts post-Tx), pictures of the transplant duodenal mucosa will be taken. The mucosal images will be rated regarding rubor, edema villous atrophy etc. and compared to biopsy rejection scores.
Endoscopic ultrasound (EUS) will be used during biopsying of the pancreas. EUS images will be sampled and stored, for comparative analysis. The EUS analysis will mainly involve circulatory parameters.

We will investigate relationships between the below mentioned donor/recipient characteristics and graft survival/surgical complications/non-surgical complications:
Donor age
Donor gender
Donor BMI
Recipient age
Recipient gender
Recipient BMI
Recipient PRA (Panel Reactive Antibody) status
Recipient comorbidity status; particularly cardiovascular status

The following analyses will be performed and correlated to rejection, functional parameters (glucose levels/need for insulin (P) and creatinine (K)), and graft survival. By daily blood samples during the first 10 days, 3 times a week until week 10, at 3 & 12 mts, and on indication.
Amylase (pancreas specific amylase)
Lipase
CRP
Amylase/Lipase/CRP combined parameter
C-peptide and C-peptide/Glucose/Creatinine-ratio (C-peptide : Glucose x Creatinine)
In addition, amylase in drainage fluid will be measured daily, until the drains are removed (usually at day 4-8 post-Tx).

At the end of surgery one catheter will be positioned ventral and one dorsal on the outside of the pancreas transplant. Each catheter will be perfused with 6 % hydroxyethyl starch at a rate of 1 µL/minute. Postoperatively, the microdialysis samples will be analyzed at the bedside for glycerol, glucose, lactate, and pyruvate using a microdialysis analyzer. Samples from both catheters will be analyzed hourly the first 24 hours and thereafter every two hours during daytime and every three hours during the night (00, 03, and 06). The catheters will be left in situ for as long as they are able to sample appropriately, or until the patient is dismissed. All microdialysis samples will be frozen at -80°C after they have been analyzed for mediators of intermediate metabolism. We will also collect EDTA plasma daily. After study completion, the microdialysis and plasma samples will be analyzed en bloc for an array of inflammatory mediators.

Ultrasound and CT examinations will be performed at postop. day 5-7 in order to:
Detect thrombotic events in the PTx and compare the results with the metabolic patterns obtained from the microdialysis cathethers.
Control the position of the microdialysis catheters
Detect other pathology; fluid accumulations, abscesses etc.
Compare the results/efficacy/sensistivity between Ultrasound and CT.

We also want to take conventional percutaneous, ultrasound-guided pancreas biopsies at 6 weeks and 12 months post-Tx - in order to compare the yield (and complications) by EUS (Cfr. Outcome 8) vs percutaneous P biopsies.

Håkon Haugaa

Principal investigator

Aarhus University Hospital

Continuous i.v. infusion of Sodium Lactate (2'400 mOsmol/L) over 3 hours

Traumatic Brain Injury

Subarachnoid Hemorrhage

3-6 hours continuous infusion of sodium lactate (20-40 mcg/kg/min)

sodium lactate infusion

CHUV, Lausanne University Hospital

Lactate Therapy After Traumatic Brain Injury

Neuroprotective Role of Lactate Therapy in Humans With Traumatic Brain Injury

Increase from baseline in brain extracellular lactate, pyruvate and glucose measured with intra-parenchymal cerebral microdialysis catheter

glycerol/pendarahan

Early Detection of Anastomotic Leakage by Microdialysis Catheters

Candida Albicans in Periodontal and Endodontic Lesions in Diabetic and Normoglycemic Patients

The Norwegian Pancreas Transplantation (PTx) Study

Lactate Therapy After Traumatic Brain Injury

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