Gastrointestinal BleedingsPhase 3PREPINTESTNCT01267981
Efficacy of Small Bowel Preparation in Capsule Endoscopy
A Phase 3 study testing Standard diet, Standard Diet + 500 ml of polyethyleneglycol and Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol in people with Gastrointestinal Bleedings, run by University Hospital, Brest at 17 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleedings
- What is being tested?
- Standard diet, Standard Diet + 500 ml of polyethyleneglycol and Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 858 participants
- Where
- 17 sitesFrance
- Study dates
- Sep 2010to Jan 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Centre Hospitalier d'Avignon
Avignon, 84000
Cabinet privé
Béziers
Centre Hospitalier d'Avicenne
Bobigny, 93000
CHOLET
Brest, 29200
CHRU de Lille
Lille, 59037
Saint Philibert Hospital
Lomme, 59160
CH Bretagne Sud
Lorient, 56100
Edouard Herriot Hospital
Lyon, 69437
Hôpital de La Conception
Marseille, 13274
Hôpital de la Timone
Marseille, 13385
Centre Hospitalier Universitaire de Nice
Nice, 06202
Hôpital Cochin
Paris, 75014
Höpital Européen Geores Pompidou
Paris, 75015
CH de Cornouaille Quimper
Quimper, 29000
Centre Hospitalier de Saint Brieuc
Saint-Brieuc, 22000
Hôpital Privé de L'Est Lyonnais
Saint-Priest, 69800
CH Bretagne Atlantique
Vannes, 56017
About this study
Official title: 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.
Read the 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:
- Inclusion
- Randomization
- Video-capsule exploration
- Reading of the video-capsule exam by endoscopist doctors who are in blind.
- Conditions
- Gastrointestinal Bleedings
- Being tested
- Standard diet, Standard Diet + 500 ml of polyethyleneglycol, Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
- Keywords
- Small bowel, video-capsule endoscopy, gastrointestinal bleeding, polyethylene glycol
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dietDrug
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 polyethyleneglycolDrug
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 glycolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Preparation 1 | Placebo comparator | 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. Receives: Drug: Standard diet |
| Preparation 2 | Active comparator | 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. Receives: Drug: Standard Diet + 500 ml of polyethyleneglycol |
| Preparation 3 | Active comparator | 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. Receives: Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of video-capsule exploration
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: at the end of video-capsule exploration
Crossing (yes or no) of ileo-cecal valve by the EVC
Measured: At the end of video-capsule exploration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal BleedingsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 858 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Franck CHOLET, MD, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267981
- Sponsor's protocol ID
- RB 09.091
- Acronym
- PREPINTEST
- Status last verified
- Nov 2017
- First submitted
- 27 Dec 2010
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35041627
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings
- ClinicalTrials.gov ID
- NCT01267981
- Acronym / sponsor ID
- PREPINTEST / RB 09.091
- Conditions
- Gastrointestinal Bleedings
- Keywords
- Small bowel, video-capsule endoscopy, gastrointestinal bleeding, polyethylene glycol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 858 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Inclusion
- Randomization
- Video-capsule exploration
- Reading of the video-capsule exam by endoscopist doctors who are in blind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preparation 1 | Placebo comparator | Drug: Standard dietStandard 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. |
| Preparation 2 | Active comparator | Drug: Standard Diet + 500 ml of polyethyleneglycolStandard 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. |
| Preparation 3 | Active comparator | Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycolStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard dietAfter 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 | Preparation 1 |
| Standard Diet + 500 ml of polyethyleneglycolApply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion. | Drug | Preparation 2 |
| Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycolapply 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. | Drug | Preparation 3 |
Primary outcome
Compare the frequencies of the diagnoses of clinically significant lesions
Time frame: at the end of video-capsule exploration
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.
5 secondary outcomes
The quality of the preparation and visibility of the bowel
Time frame: at the end of video-capsule exploration
The clinical tolerance
Time frame: 8 days after video-capsule exploration
The number of all the observed lesions
Time frame: at the end of video-capsule exploration
Compare different times
Time frame: at the end of video-capsule exploration
Crossing (yes or no) of ileo-cecal valve by the EVC
Time frame: At the end of video-capsule exploration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 35041627Rahmi 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck CHOLET, MD principal investigator
CHRU BREST
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard diet, Standard Diet + 500 ml of polyethyleneglycol and Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol in people with Gastrointestinal Bleedings, run by University Hospital, Brest at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the frequencies of the diagnoses of clinically significant lesions (time frame: at the end of video-capsule exploration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01267981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.