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Prevalence of Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma

Prevalence, With Medical Imaging, of the Parenchymatous and/or Ductal Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02810730
Acronym
PAPAFA
Enrollment
200
Registered
2016-06-23
Start date
2015-06-30
Completion date
2016-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevalence of Pancreas Adenocarcinomas

Keywords

pancreas, adenocarcinoma

Brief summary

Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is increasing both in France and in Europe, whereas all the other cancers are decreasing in Europe. Moreover, its seriousness is still high, with a mortality rate higher than the average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic anomalies which can be revealed thanks to imaging, for patients having a 1st degree pancreatic adenocarcinoma familial history. This could allow detection of lesions which are less than 10 mm long, and improve the dark prognostic of this pathology.

Interventions

PROCEDUREPancreatic MRI

Pancreatic MRI in the 6 months following the first consultation

Sponsors

Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* patients with a 1st degree familial history of pancreas adenocarcinoma * patients older than 40 * patients whose life expectancy is \> 3 months * inform and consent form signed * patient insured under the French social security system

Exclusion criteria

* contraindication to the MRI (pace-maker, implanted metallic material, medical history of allergy to the contrast agent, end-stage renal failure, pregnancy, claustrophobia) * contraindication to anesthesia to do the echo endoscopy * 1st degree family history of 2 pancreas adenocarinomas * medical history of allergy to benzylic alcool * contraindication to dimeglumine gadobenate * pregnant or breastfeeding woman, according to the questioning * subjets who don't have the legal capacity to consent

Design outcomes

Primary

MeasureTime frameDescription
Number of patients for whom the MRI and/or the echo endoscopy has shown a parenchymatous or ductal pancreatic anomalysix months after the last inclusionFor every patients who will have a pancreatic MRI detecting an anomaly, the echo endoscopy will be done. A cytology of the lesion from the echo endoscopy will be done for the solid lesions and for the indetermined cystic lesions (that is to say, the lesions which don't meet the literature set criteria for serous kyst or intraductal papillary and mucinous tumor of the pancreas) ; which is usually done in health care.

Secondary

MeasureTime frame
Number of patients for whom the echo endoscopy has brought to light a parenchymatous and/or ductal pancreatic anomalysix months after the last inclusion
Height of the lesionssix months after the last inclusion
Correlation between the data from the MRI and those from the echo endoscopysix months after the last inclusion
Number of patients for whom the MRI has brought to light a parenchymatous and/or ductal pancreatic anomalysix months after the last inclusion
Number of lesionssix months after the last inclusion
Aspect of the lesion (solid and/or liquid)six months after the last inclusion
Localisation of the lesionssix months after the last inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026