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

Pancreatic Fistula Clinical Trial

— LIPA-DRAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784990
• Other study ID #: FACY PHRCI 2015
• Status: Completed
• Start date: June 3, 2016
• Est. completion date: November 3, 2020

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

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

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besancon
France	CHU William MOREY	Chalon-sur-Saône
France	CHU Dijon Bourgogne	Dijon
France	CHU Grenoble Alpes	La Tronche
France	Hopital Claude Huriez	Lille
France	HCL - Hôpital universitaire de la Croix Rousse	Lyon
France	APHM - Institut Paoli-Calmettes	Marseille
France	CHU de REIMS - Hôpital Robert Debré	Reims
France	Hôpital Hautepierre	Strasbourg
France	CHU de NANCY	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of lipase in the drains		3 days after surgical resection