Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy

Pediatric Disorder Clinical Trial

Official title:

Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662113
• Other study ID #: DomperidoneVCE
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: December 2018
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce the chances of an incomplete small bowel examination via decrease gastric transit time (GTT). Investigators are aimed to prospectively compare the completion rate of VCE in pediatric patients receiving prokinetic with those receiving no prokinetic.

Description:

Eligible children were randomly divided into two groups: domperidone prior to VCE and water prior to VCE. The primary outcome measure was the completion rate. Secondary outcome measures included the GTT and SBTT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Indications of capsule endoscopy;

• Informed consent form obtained.

Exclusion Criteria:

• Contraindication of capsule endoscopy;

• Domperidone allergy;

• Unwilling to participate.

Related Conditions & MeSH terms

• Capsule Endoscopy
• Pediatric Disorder

Intervention

Drug:
• Domperidone
5ml Domperidone prior to VCE

Dietary Supplement:
• water
5ml water prior to VCE

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

Mcfarlane M, Liu B, Nwokolo C. Domperidone prolongs oral to duodenal transit time in video capsule endoscopy. Eur J Clin Pharmacol. 2018 Apr;74(4):521-524. doi: 10.1007/s00228-017-2399-8. Epub 2017 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of capsule endoscopy	CE was considered complete when the cecum was reached within recording time.	assessed through study completion, an average of 1 year
Secondary	Gastric transit time (GTT)	The GTT was defined as the time, in minutes, from the first image of the stomach until the first image of the duodenum.	assessed through study completion, an average of 1 year
Secondary	small bowel transit time (SBTT)	The SBTT was defined as the passage time, in minutes, from the first image of the duodenum until the first image of the cecum.	assessed through study completion, an average of 1 year