Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions (LIPA-DRAIN)

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Pancreatic Fistula

Treatments: Biological: Lipase, amylase and CRP (C-reactive protein) dosages

Study type: Observational

Funder types: Other

Identifiers

NCT02784990

FACY PHRCI 2015

Details and patient eligibility

About

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.

Enrollment: 770 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

770 participants in 1 patient group

Patient

Treatment:

Biological: Lipase, amylase and CRP (C-reactive protein) dosages