Pancreatic FistulaLIPA-DRAINNCT02784990
Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions
An observational study of Pancreatic Fistula, run by Centre Hospitalier Universitaire Dijon at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Lipase, amylase and CRP (C-reactive protein) dosages
- How many people
- 770 participants
- Where
- 10 sitesFrance
- Study dates
- 3 Jun 2016to 3 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing scheduled pancreatic resection
Who may be able to join
- 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
Who cannot join
- Patients with scheduled total pancreatectomy
- Adults under wardship
- Pregnant or breast-feeding women
- Total pancreatectomy
- Pancreatectomy not feasible
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Jean Minjoz
Besançon, 25030
CHU William MOREY
Chalon-sur-Saône, 71321
CHU Dijon Bourgogne
Dijon, 21079
CHU Grenoble Alpes
La Tronche, 38700
Hopital Claude Huriez
Lille, 59037
HCL - Hôpital universitaire de la Croix Rousse
Lyon, 69317
APHM - Institut Paoli-Calmettes
Marseille, 13009
CHU de REIMS - Hôpital Robert Debré
Reims, 51100
Hôpital Hautepierre
Strasbourg, 67098
CHU de NANCY
Vandœuvre-lès-Nancy, 54511
About this study
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.
Read more
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.
- Conditions
- Pancreatic Fistula
- Being tested
- Lipase, amylase and CRP (C-reactive protein) dosages
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipase, amylase and CRP (C-reactive protein) dosagesBiological
| Study group | Role | What they receive |
|---|---|---|
| Patient | Not described Receives: Biological: Lipase, amylase and CRP (C-reactive protein) dosages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of lipase in the drains
Measured: 3 days after surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start3 Jun 2016
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784990
- Sponsor's protocol ID
- FACY PHRCI 2015
- Acronym
- LIPA-DRAIN
- Status last verified
- Feb 2026
- First submitted
- 18 May 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
Publications
Doussot B, Doussot A, Ayav A, Santucci N, Deguelte S, Sow AK, El Amrani M, Duvillard L, Piessen G, Girard E, Mabrut JY, Garnier J, Ortega-Deballon P, Fournel I, Facy O. Diagnostic Accuracy of Lipase as Early Predictor of Postoperative Pancreatic Fistula: Results from the LIPADRAIN study. Ann Surg Open. 2024 Sep 11;5(3):e492. doi: 10.1097/AS9.0000000000000492. eCollection 2024 Sep.
PubMed 39310332
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions
- ClinicalTrials.gov ID
- NCT02784990
- Acronym / sponsor ID
- LIPA-DRAIN / FACY PHRCI 2015
- Conditions
- Pancreatic Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Biological: Lipase, amylase and CRP (C-reactive protein) dosages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing scheduled pancreatic resection
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Patients with scheduled total pancreatectomy
- Adults under wardship
- Pregnant or breast-feeding women
- Total pancreatectomy
- Pancreatectomy not feasible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipase, amylase and CRP (C-reactive protein) dosages | Biological | Patient |
Primary outcome
Dosage of lipase in the drains
Time frame: 3 days after surgical resection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 39310332Doussot B, Doussot A, Ayav A, Santucci N, Deguelte S, Sow AK, El Amrani M, Duvillard L, Piessen G, Girard E, Mabrut JY, Garnier J, Ortega-Deballon P, Fournel I, Facy O. Diagnostic Accuracy of Lipase as Early Predictor of Postoperative Pancreatic Fistula: Results from the LIPADRAIN study. Ann Surg Open. 2024 Sep 11;5(3):e492. doi: 10.1097/AS9.0000000000000492. eCollection 2024 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Fistula, run by Centre Hospitalier Universitaire Dijon at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of lipase in the drains (time frame: 3 days after surgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.