Efficacy of Small Bowel Preparation in Capsule Endoscopy

Gastrointestinal Bleedings Clinical Trial

— PREPINTEST  

Official title:

Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267981
• Other study ID #: RB 09.091
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2010
• Last updated: June 6, 2016
• Start date: September 2010
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The best preparation of small bowel is still unknown. The primary aim of this study is to evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained gastrointestinal bleeding exploration. Three different preparations are evaluated in this study.

Description:

Now days, the endoscopic video-capsule is the more appropriate exam for unexplained gastrointestinal bleeding exploration. The responsible damage of this unexplained bleeding are frequently small vascular damages, hard to be detected in the bowel or ulcerations or tumors. The exam quality can be limited by food residues, bubbles or bile.

30% of damage are probably undetectable because of a lack of visibility. An efficient preparation will probably increased the quality of the video-capsule exploration.

The bowel exploration by endoscopy video-capsule will be realized in the usual condition. The study included 4 steps:

1. Inclusion

2. Randomization

3. Video-capsule exploration

4. Reading of the video-capsule exam by endoscopist doctors who are in blind.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 858
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years old.

• Patients who have an indication for video-capsule endoscopy exploration for unexplained gastrointestinal bleeding associated with anaemia (man : haemoglobin <13 g/dl and woman haemoglobin <12g/dl)

• Less than one year Endoscopic assessment by colonoscopy and gastroscopy

• Not participated to an another clinic study.

• Written consent.

Exclusion Criteria:

• Age<18 years old.

• General physical health deterioration such as dehydration or cardiac insufficiency.

• Clinical or radiological suspicion of digestive stenosis.

• Oral iron taking in the 4 days before video-capsule exploration.

• Functional or organic disorders of the gulp

• Pregnant women.

• Sensibility known about the polyethylene glycol.

• No signed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Bleedings
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Drug:
• Standard diet
After the lunch the day before the exploration, drink only clear liquids and stop solid food. From 10 pm, stay fasting, don't drink except the usual drugs taken with mouthful of water until the exploration by video-capsule endoscopy.
• Standard Diet + 500 ml of polyethyleneglycol
Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
• Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
apply the standard diet and drink 2 liters of polyethylene glycol between 19h and 21h the day before exploration. Then drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.

Locations

Country	Name	City	State
France	Centre Hospitalier d'Avignon	Avignon
France	Cabinet privé	Beziers
France	Centre Hospitalier d'Avicenne	Bobigny
France	CHOLET	Brest
France	CHRU de Lille	Lille
France	Saint Philibert Hospital	Lomme
France	CH Bretagne Sud	Lorient
France	Edouard Herriot Hospital	Lyon
France	Hôpital de La Conception	Marseille
France	Hôpital de la Timone	Marseille
France	Centre Hospitalier Universitaire de Nice	Nice
France	Hôpital Cochin	Paris
France	Höpital Européen Geores Pompidou	Paris
France	CH de Cornouaille Quimper	Quimper
France	Centre Hospitalier de Saint Brieuc	Saint Brieuc
France	Hôpital Privé de L'Est Lyonnais	Saint Priest
France	CH Bretagne Atlantique	Vannes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the frequencies of the diagnoses of clinically significant lesions	Compare the frequencies of the diagnoses of clinically significant lesions (P1 or P2)obtained with and without polyethylene glycol preparation for patients investigated by video-capsule endoscopy who have an unexplained digestive bleeding.	at the end of video-capsule exploration	No
Secondary	The quality of the preparation and visibility of the bowel	Demonstrate an improvement in preparation quality and bowel visibility in the various segments of small bowel examined by video-capsule endoscopy	at the end of video-capsule exploration	No
Secondary	The clinical tolerance	Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution	8 days after video-capsule exploration	Yes
Secondary	The number of all the observed lesions	Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.	at the end of video-capsule exploration	No
Secondary	Compare different times	Compare gastric emptying time, the bowel transit time and the percentage complete medical exploration of small bowel for every group of patients (ileo- cecal valve exceeded).	at the end of video-capsule exploration	No
Secondary	Crossing (yes or no) of ileo-cecal valve by the EVC		At the end of video-capsule exploration	No