NCT02784990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

June 3, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

May 18, 2016

Last Update Submit

February 4, 2026

Conditions

Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

  • Dosage of lipase in the drains

    3 days after surgical resection

Study Arms (1)

Patient

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

Interventions

Lipase, amylase and CRP (C-reactive protein) dosagesBIOLOGICAL
Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing scheduled pancreatic resection

You may qualify if:

  • 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

You may not qualify if:

  • Patients with scheduled total pancreatectomy
  • Adults under wardship
  • Pregnant or breast-feeding women
  • Total pancreatectomy
  • Pancreatectomy not feasible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Jean Minjoz

Besançon, 25030, France

Location

CHU William MOREY

Chalon-sur-Saône, 71321, France

Location

CHU Dijon Bourgogne

Dijon, 21079, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

Hopital Claude Huriez

Lille, 59037, France

Location

HCL - Hôpital universitaire de la Croix Rousse

Lyon, 69317, France

Location

APHM - Institut Paoli-Calmettes

Marseille, 13009, France

Location

CHU de REIMS - Hôpital Robert Debré

Reims, 51100, France

Location

Hôpital Hautepierre

Strasbourg, 67098, France

Location

CHU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • 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.

    PMID: 39310332RESULT

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

LipaseAmylasesC-Reactive Protein

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesGlycoside HydrolasesAlbuminsProteinsAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood ProteinsImmunoproteins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 27, 2016

Study Start

June 3, 2016

Primary Completion

November 3, 2020

Study Completion

November 3, 2020

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

FR(10)