Button Battery PoisoningPILBOUTOXNCT03708250
PilBouTox® Project: Button Battery Poisoning From Data Collected by French Poison Control Centres
An observational study of Button Battery Poisoning, run by University Hospital, Bordeaux at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Button Battery Poisoning
- How many people
- 510 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Jun 2016to 31 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Animal cases
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Anti Poison
Angers
Centre Anti Poison
Lille
Centre Anti Poison
Lyon
Centre Anti Poison
Marseille
Centre Anti Poison
Nancy
Centre Anti Poison
Paris
Centre Anti Poison
Strasbourg
Centre Anti Poison
Toulouse
About this study
Official title: PilBouTox® Project: Prospective and Descriptive Study About Button Battery Poisoning Performed on Data Collected by French Poison Control Centres (PCC)
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
Read the 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.
- Conditions
- Button Battery Poisoning
- Keywords
- button battery, intoxication, oesophageal necrosis, Poison Control Centre, Poisoning
- Medical subject headings
- Poisoning
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of a serious complication
occurrence of a serious complication
Measured: Baseline
Secondary outcomes (8)
Need for surgery
Need for surgery
Measured: baseline
Length of hospital stay
Length of hospital stay
Measured: baseline
Death
Death
Measured: baseline
Battery Size
Battery Size
Measured: baseline
Battery Voltage
Battery Voltage
Measured: baseline
Presence of Lying
Presence of Lying
Measured: baseline
Length of Insertion
Length of Insertion
Measured: baseline
Abnormalities at First Fibroscopy
Abnormalities at First Fibroscopy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Jun 2016
- Primary completion31 May 2018
- Study completion31 May 2018
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 Button Battery PoisoningStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708250
- Sponsor's protocol ID
- CHUBX 2018/54
- Acronym
- PILBOUTOX
- Status last verified
- Apr 2023
- First submitted
- 12 Oct 2018
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35841456
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PilBouTox® Project: Prospective and Descriptive Study About Button Battery Poisoning Performed on Data Collected by French Poison Control Centres (PCC)
- ClinicalTrials.gov ID
- NCT03708250
- Acronym / sponsor ID
- PILBOUTOX / CHUBX 2018/54
- Conditions
- Button Battery Poisoning
- Keywords
- button battery, intoxication, oesophageal necrosis, Poison Control Centre, Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 17 Oct 2018 (actual)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Animal cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of a serious complication
Time frame: Baseline
occurrence of a serious complication
8 secondary outcomes
Need for surgery
Time frame: baseline
Length of hospital stay
Time frame: baseline
Death
Time frame: baseline
Battery Size
Time frame: baseline
Battery Voltage
Time frame: baseline
Presence of Lying
Time frame: baseline
Length of Insertion
Time frame: baseline
Abnormalities at First Fibroscopy
Time frame: baseline
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 28 Apr 2023.
- Derived from this study: PubMed 35841456Labadie 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.
- Individual participant dataSharing planned: No
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Button Battery Poisoning, run by University Hospital, Bordeaux at 8 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 1 inclusion and 1 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
occurrence of a serious complication (time frame: Baseline). 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 NCT03708250, 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 28 Apr 2023.