Efficacy of Small Bowel Preparation in Capsule Endoscopy (PREPINTEST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University Hospital, Brest
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01267981
First received: December 27, 2010
Last updated: October 16, 2014
Last verified: October 2014

December 27, 2010
October 16, 2014
September 2010
September 2015   (final data collection date for primary outcome measure)
Compare the frequencies of the diagnoses of clinically significant lesions [ Time Frame: at the end of video-capsule exploration ] [ Designated as safety issue: No ]
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.
Compare the frequencies of the diagnoses of clinically significant lesions [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
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 (VCE) who have an unexplained digestive bleeding.
Complete list of historical versions of study NCT01267981 on ClinicalTrials.gov Archive Site
  • The quality of the preparation and visibility of the bowel [ Time Frame: at the end of video-capsule exploration ] [ Designated as safety issue: No ]
    Demonstrate an improvement in preparation quality and bowel visibility in the various segments of small bowel examined by video-capsule endoscopy
  • The clinical tolerance [ Time Frame: 8 days after video-capsule exploration ] [ Designated as safety issue: Yes ]
    Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution
  • The number of all the observed lesions [ Time Frame: at the end of video-capsule exploration ] [ Designated as safety issue: No ]
    Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.
  • Compare different times [ Time Frame: at the end of video-capsule exploration ] [ Designated as safety issue: No ]
    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).
  • Crossing (yes or no) of ileo-cecal valve by the EVC [ Time Frame: At the end of video-capsule exploration ] [ Designated as safety issue: No ]
  • The quality of the preparation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Demonstrate an improvement of the quality of the preparation in the various segments of the small bowel examinated by video capsule endoscopy
  • The clinical tolerance [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution
  • The number of all the observed lesions [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.
  • Compare differents times [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Compare gastric emptying time, the bowel transit time and the percentage complete medical exploration of small bowel for every group of patients (ileo caecal valve exceeded).
Not Provided
Not Provided
 
Efficacy of Small Bowel Preparation in Capsule Endoscopy
Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Gastrointestinal Bleedings
  • 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.

  • Drug: 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.
  • Drug: 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.
  • Placebo Comparator: Preparation 1
    Standard diet: the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water.
    Intervention: Drug: Standard diet
  • Active Comparator: Preparation 2

    Standard diet : the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water.

    500 ml of polyethylene glycol 30 minutes after the ingestion of video-capsule endoscopy.

    Intervention: Drug: Standard Diet + 500 ml of polyethyleneglycol
  • Active Comparator: Preparation 3

    Standard diet : the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water.

    2 liters of polyethylene glycol between 7 pm and 9 pm.

    500 ml of polyethylene glycol, 30 minutes after the ingestion of video-capsule endoscopy.

    Intervention: Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
858
September 2016
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Franck CHOLET, MD 298347149 ext +33 franck.cholet@chu-brest.fr
France
 
NCT01267981
RB 09.091
No
University Hospital, Brest
University Hospital, Brest
Ministry of Health, France
Principal Investigator: Franck CHOLET, MD CHRU Brest
University Hospital, Brest
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP