Efficacy of Small Bowel Preparation in Capsule Endoscopy (PREPINTEST)

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Bleedings
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 858
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84000
    • Centre Hospitalier d'Avignon
  • Beziers, France
    • Cabinet privé
  • Bobigny, France, 93000
    • Centre Hospitalier d'Avicenne
  • Brest, France, 29200
    • CHOLET
  • Lille, France, 59037
    • CHRU de Lille
  • Lomme, France, 59160
    • Saint Philibert Hospital
  • Lorient, France, 56100
    • CH Bretagne Sud
  • Lyon, France, 69437
    • Edouard Herriot Hospital
  • Marseille, France, 13385
    • Hopital de la Timone
  • Marseille, France, 13274
    • Hôpital de la Conception
  • Nice, France, 06202
    • Centre Hospitalier Universitaire de Nice
  • Paris, France, 75014
    • Hôpital Cochin
  • Paris, France, 75015
    • Höpital Européen Geores Pompidou
  • Quimper, France, 29000
    • CH de Cornouaille Quimper
  • Saint Brieuc, France, 22000
    • Centre Hospitalier de Saint Brieuc
  • Saint Priest, France, 69800
    • Hôpital Privé de L'Est Lyonnais
  • Vannes, France, 56017
    • CH Bretagne Atlantique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Crossing (yes or no) of ileo-cecal valve by the EVC		At the end of video-capsule exploration

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Franck CHOLET, MD, CHRU Brest

Publications and helpful links

General Publications

• Rahmi G, Cholet F, Gaudric M, Filippi J, Duburque C, Bramli S, Quentin V, Alavi Z, Nowak E, Saurin JC, Cellier C, Queneherve L; PREPINTEST working group. Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2022 Feb 1;117(2):327-335. doi: 10.14309/ajg.0000000000001597.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 27, 2010
• First Submitted That Met QC Criteria: December 28, 2010
• First Posted (Estimate): December 29, 2010

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: polyethylene glycol; gastrointestinal bleeding; Small bowel; video-capsule endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: RB 09.091