Clinical trial NCT02784990: Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions
Official title: Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Fistula
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing scheduled pancreatic resection

Brief summary: Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery can be accompanied by complications among which the main one is pancreatic fistula, which leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity, a fistula can be managed medically, with the implantation of a la pose d'un percutaneous drain, endoscopic treatment, or revisit surgery. It has been shown that early management of the fistula prevents it from evolving towards major complications such as haemorrhage or serious intra-abdominal infections.

To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic enzyme, amylase, in the drains. However in certain clinical situations, patients present post-operative fistulas with no elevation of amylase. And, on the contrary, increased amylase with no clinical consequences.

It is therefore necessary to identify another early early marker of pancreatic fistula that corresponds better to clinical signs.

In a preliminary study conducted in 65 patients, the investigators recently found that another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula, but this requires confirmation in a greater number of patients.

The objective is to evaluate the diagnostic performance of lipase in the drains for the early detection of pancreatic fistula with clinical repercussions in the 30 days following the surgery.

The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of blood and a tube of drain liquid.


Eligibility criteria: Inclusion Criteria:

* Patients over 18
* Patients undergoing scheduled pancreatic resection with or without anastomosis (cephalic duodenopancreatectomy, median pancreatectomy, left pancreatectomy, enucleation)
* Patients able to understand instructions/information
* Patients who have provided written informed consent
* Patients with Health Insurance cover

Exclusion Criteria:

* Patients with scheduled total pancreatectomy
* Adults under wardship
* Pregnant or breast-feeding women
* Total pancreatectomy
* Pancreatectomy not feasible

Primary outcomes:
measure: Dosage of lipase in the drains
timeFrame: 3 days after surgical resection
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Chalon-sur-Saône
country: France
facility: CHU William MOREY
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: Hopital Claude Huriez
city: Lyon
country: France
facility: HCL - Hôpital universitaire de la Croix Rousse
city: Marseille
country: France
facility: APHM - Institut Paoli-Calmettes
city: Reims
country: France
facility: CHU de REIMS - Hôpital Robert Debré
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Vandoeuvre Les Nancy
country: France
facility: CHU de NANCY
Study officials:
References: