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

Completed

• Conditions: Pancreatic Fistula
• Interventions: Biological: Lipase, amylase and CRP (C-reactive protein) dosages

• Registration Number: NCT02784990
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Study Start: 2016-06-03
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient	Lipase, amylase and CRP (C-reactive protein) dosages	-

Primary Outcome Measures

Name	Time	Method
Dosage of lipase in the drains	3 days after surgical resection

Trial Locations

Locations (10)

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

CHU de REIMS - Hôpital Robert Debré; 🇫🇷 Reims, France

APHM - Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Hôpital Hautepierre; 🇫🇷 Strasbourg, France

CHU de NANCY; 🇫🇷 Vandoeuvre Les Nancy, France