PilBouTox® Project: Button Battery Poisoning From Data Collected by French Poison Control Centres (PILBOUTOX)

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

Study Overview

• Status: Completed
• Conditions: Button Battery Poisoning

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 Type: Observational
• Enrollment (Actual): 510

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Centre Anti Poison
  • Lille, France
    • Centre Anti Poison
  • Lyon, France
    • Centre Anti Poison
  • Marseille, France
    • Centre Anti Poison
  • Nancy, France
    • Centre Anti Poison
  • Paris, France
    • Centre Anti Poison
  • Strasbourg, France
    • Centre Anti Poison
  • Toulouse, France
    • Centre Anti Poison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of a serious complication	occurrence of a serious complication	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for surgery	Need for surgery	baseline
Length of hospital stay	Length of hospital stay	baseline
Death	Death	baseline
Battery Size	Battery Size	baseline
Battery Voltage	Battery Voltage	baseline
Presence of Lying	Presence of Lying	baseline
Length of Insertion	Length of Insertion	baseline
Abnormalities at First Fibroscopy	Abnormalities at First Fibroscopy	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: intoxication; Poisoning; button battery; oesophageal necrosis; Poison Control Centre
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning
• Other Study ID Numbers: CHUBX 2018/54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No