Efficacy of Small Bowel Preparation in Capsule Endoscopy (PREPINTEST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Bleedings
Drug: Standard diet
Drug: Standard Diet + 500 ml of polyethyleneglycol
Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 858
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

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.
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.

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.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267981

Contacts
Contact: Franck CHOLET, MD 298347149 ext +33 franck.cholet@chu-brest.fr

Locations
France
Centre Hospitalier d'Avignon Recruiting
Avignon, France, 84000
Contact: Slim BRAMLI, Dr         
Cabinet privé Recruiting
Beziers, France
Contact: Pierre DALBIES, Doctor         
Principal Investigator: Pierre DALBIES, Doctor         
Centre Hospitalier d'Avicenne Not yet recruiting
Bobigny, France, 93000
Contact: Robert BENAMOUZIG, Pr         
CHOLET Recruiting
Brest, France, 29200
Contact: Franck Cholet, MD    298347149 ext +33    franck.cholet@chu-brest.fr   
Sub-Investigator: Gilles Calament, MD         
Sub-Investigator: Joseph Fayçal, MD         
Sub-Investigator: Bertrand Geier, MD         
CHRU de Lille Recruiting
Lille, France, 59037
Contact: Vincent Maunoury, MD         
Saint Philibert Hospital Recruiting
Lomme, France, 59160
Contact: Bernard Filoche, MD    320225068 ext +33    filoche.bernard@ghicl.net   
Edouard Herriot Hospital Recruiting
Lyon, France, 69437
Contact: Jean-Christophe Saurin, PHD    472110146 ext +33    saurin@lyon151.inserm.fr   
Sub-Investigator: Thierry Ponchon, PHD         
Hôpital de La Conception Recruiting
Marseille, France, 13274
Contact: Laurent Heyries, MD    491383696 ext +33    laurent.heyries@ap-hm.fr   
Hôpital de la Timone Recruiting
Marseille, France, 13385
Contact: René Laugier, PHD    491386023 ext +33    rlaugier@mai.ap-hm.fr   
Sub-Investigator: Denis Monges, MD         
Centre Hospitalier Universitaire de Nice Recruiting
Nice, France, 06202
Contact: Geoffroy Vanbiervliet, MD    492036385 ext +33    vanbiervliet.g@chu-nice.fr   
Sub-Investigator: Jérôme Filippi, MD         
Höpital Européen Geores Pompidou Recruiting
Paris, France, 75015
Contact: Christophe Cellier, PHD    156093552    christophe.cellier@egp.aphp.fr   
Sub-Investigator: Camille Savale, MD         
Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Marianne Gaudric, MD    158411954 ext +33    marianne.gaudric@cch.ap-hop-paris.fr   
Centre Hospitalier de Saint Brieuc Recruiting
Saint Brieuc, France, 22000
Contact: Vincent Quentin, MD         
Sub-Investigator: Michèle Le Bris, MD         
Hôpital Privé de L'Est Lyonnais Recruiting
Saint Priest, France, 69800
Contact: Marie-Georges Lapalus, MD    437544065 ext +33    mglapalus@gmail.com   
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
Principal Investigator: Franck CHOLET, MD CHRU Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01267981     History of Changes
Other Study ID Numbers: RB 09.091
Study First Received: December 27, 2010
Last Updated: April 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Small bowel
video-capsule endoscopy
gastrointestinal bleeding
polyethylene glycol

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014