NCT Number: NCT02784990
Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
CHU Jean Minjoz, Besançon, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Dosage of lipase in the drains
Time frame: 3 days after surgical resection
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire Dijon
Other
Registry information
Acronym: LIPA-DRAIN
Important dates
- Study start
- 2016
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- May 27, 2016
- Registry last updated
- Feb 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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