Clinical trial NCT03708250: PilBouTox® Project: Button Battery Poisoning From Data Collected by French Poison Control Centres
Official title: PilBouTox® Project: Prospective and Descriptive Study About Button Battery Poisoning Performed on Data Collected by French Poison Control Centres (PCC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Button Battery Poisoning
Keywords: button battery
intoxication
oesophageal necrosis
Poison Control Centre
Poisoning
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 510
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone who calls for exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology.

Brief summary: Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. There are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. The main objective of this study is to precisely describe poisoning cases by button battery in order to propose a better management

Detailed description: Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. The most serious cases are those related to the ingestion of button cells, especially in children, when the battery gets stuck in the esophagus. Poison control centres, as well as addictovigilance centres, are regularly called upon for serious poisoning resulting in hospitalization, for which precisely description is most often missing or difficult to obtain and limits the efficiency of the management of these poisonings. So there are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. For example, in many cases, there is a lack of detail of initial symptoms, delays between symptoms and completion of further tests, follow-ups... A prospective and descriptive study about button battery poisoning performed on data collected by French PCC will be conducted between the 1st June of 2016 and the 31 May of 2018: any call in a PCC that occurred during the period studied and concerning an exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology will be included. The following data will be taken : severe complication, need for surgery, length of hospital stay, death, risk factors concerning the battery (size, voltage), abnormalities at the first fibroscopy.

Eligibility criteria: Inclusion Criteria:

Any call that occurred during the period studied in a Poison Control Centre and concerning an exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology.

Exclusion Criteria:

Animal cases

Primary outcomes:
measure: occurrence of a serious complication
timeFrame: Baseline
Secondary outcomes:
measure: Need for surgery
timeFrame: baseline
measure: Length of hospital stay
timeFrame: baseline
measure: Death
timeFrame: baseline
measure: Battery Size
timeFrame: baseline
measure: Battery Voltage
timeFrame: baseline
measure: Presence of Lying
timeFrame: baseline
measure: Length of Insertion
timeFrame: baseline
measure: Abnormalities at First Fibroscopy
timeFrame: baseline
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Anti Poison
city: Lille
country: France
facility: Centre Anti Poison
city: Lyon
country: France
facility: Centre Anti Poison
city: Marseille
country: France
facility: Centre Anti Poison
city: Nancy
country: France
facility: Centre Anti Poison
city: Paris
country: France
facility: Centre Anti Poison
city: Strasbourg
country: France
facility: Centre Anti Poison
city: Toulouse
country: France
facility: Centre Anti Poison
Study officials:
References:
citation: Labadie M, Vaucel JA, Courtois A, Nisse P, Legeay M, Medernach C, Patat AM, Von Fabeck K, Gallart JC; French PCC Research Group; Tournoud C, Puskarczyk E. Button Battery Ingestion in Children (PilBouTox(R)): A Prospective Study Describing the Clinical Course and Identifying Factors Related to Esophageal Impaction or Severe Cases. Dysphagia. 2023 Feb;38(1):446-456. doi: 10.1007/s00455-022-10485-7. Epub 2022 Jul 16.