Obscure Gastrointestinal BleedingPrepRICENCT05140057
Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield
A study testing Moviprep in people with Obscure Gastrointestinal Bleeding, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 1 site in Portugal.
Trial summary
Small bowel capsule endoscopy (SBCE) has become an important tool in clinical practice since its introduction in 2000. This non-invasive method allows the visualization of small bowel mucosa, being essential in the management of many conditions, such as suspected small bowel bleeding, inflammatory bowel diseases and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obscure Gastrointestinal Bleeding
- What is being tested?
- Moviprep
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2021to 31 Oct 2023
- Phase
- Interventional
- 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
- Be 18 years old or older
- Present OGIB (either occult or overt)
- Agree with study's procedures and have signed the informed consent for the study and SBCE, prior to SBCE procedure
Who cannot join
- Patients performing capsule endoscopy in urgent setting for overt obscure GI bleeding
- Inpatients or bedridden
- History of surgery of the esophagus, stomach, small bowel, or colon
- History of abdominal or pelvic radiation therapy
- Suspected or confirmed stenosis or occlusion
- Suspected or confirmed bowel perforation
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- Severe comorbidities, as defined by grade 3 "severe decompensation" in the Adult Comorbidity Evaluation-27 index (ACE-27)
- Pregnant women
- Patients using narcotics or prokinetics in the week before the SBCE
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia
Manuela Estevinho, +351 227865100, mmestevinho@gmail.com
Rolando Pinho
About this study
Official title: Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield: a Randomized Trial
Small bowel capsule endoscopy (SBCE) has become an important tool in clinical practice since its introduction in 2000. This non-invasive method allows the visualization of small bowel mucosa, being essential in the management of many conditions, such as suspected small bowel bleeding, inflammatory bowel diseases and intestinal polyposis syndromes. Despite recommendations concerning SBCE in different pathologies, there are still some technical concerns to be addressed. The optimal preparation for SBCE has been one of these controversial issues.
Currently, the European Society of Gastrointestinal Endoscopy (ESGE) recommends that patients ingest a purgative agent (2L of polyethylene glycol, PEG) and antifoaming agents for SBCE, because it was associated with a better visualization. However, it remains unclear which is the optimal timing for purgative use. Furthermore, the use of a booster agent after capsule ingestion is already performed in colon capsule endoscopy, but less is known about its application in SBCE. Also, it remains to be clarified whether a better visualization results in higher diagnostic yield and impacts patients' outcomes.
Read more
Therefore, the global aim of this prospective, randomized, multi-centric study is to determine the optimal timing and preparation for small-bowel capsule endoscopy (regardless of the equipment used), comparing four groups of different preparation protocols:
- Protocol 1) 1L of Moviprep® solution the night before the procedure
- Protocol 2) 1L of Moviprep® solution up to 2h before the procedure
- Protocol 3) 0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum (assessed with real-time viewer)
- Protocol 4) 1L of Moviprep® solution after the capsule had reached the duodenum (assessed using real-time viewer)
- Conditions
- Obscure Gastrointestinal Bleeding
- Being tested
- Moviprep
- Keywords
- Small bowel capsule endoscopy, Obscure gastrointestinal bleeding, Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoviprepCombination product
Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings
| Study group | Role | What they receive |
|---|---|---|
| Protocol 1 | Experimental | 1L of Moviprep® solution the night before the procedure Receives: Combination Product: Moviprep |
| Protocol 2 | Experimental | 1L of Moviprep® solution up to 2h before the procedure Receives: Combination Product: Moviprep |
| Protocol 3 | Experimental | 0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum Receives: Combination Product: Moviprep |
| Protocol 4 | Experimental | 1L of Moviprep® solution after the capsule had reached the duodenum Receives: Combination Product: Moviprep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Proportion of SBCE with positive findings. findings will be classified based on the Saurin classification; the investigators will consider a positive SBCE when lesions classified as P2 or active bleeding are detected (Saurin classification, Table 2), the remaining will be classified as negative
Measured: During the procedure
Adequate cleansing rate
A cutoff value of quantitative index ≥ 8 points
Measured: During the procedure
Secondary outcomes (7)
Proportion of SBCE with vascular lesions
Vascular lesions identified in each tertile
Measured: During the procedure
Proportion of SBCE with active bleeding
Active bleeding in each tertile
Measured: During the procedure
Diagnostic yield per tertile
Positive findings in each tertile
Measured: During the procedure
Transit times
Time of entry in the stomach, duodenum and cecum
Measured: During the procedure
Symptoms experienced during SBCE procedure
Nausea, vomit, bloating, abdominal pain
Measured: During the procedure
Overall patients' satisfaction with the cleansing regimen
rated on a 5-point scale: 1 - very easy, 2 - easy, 3 - intermediate, 4 - difficult, 5 - very difficult
Measured: During the procedure
Small bowel cleansing
Mean quantitative index of the distal third of small bowel
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obscure Gastrointestinal BleedingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Manuela Estevinho, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140057
- Sponsor's protocol ID
- 0001
- Acronym
- PrepRICE
- Status last verified
- Nov 2021
- First submitted
- 5 Oct 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05140057
- Acronym / sponsor ID
- PrepRICE / 0001
- Conditions
- Obscure Gastrointestinal Bleeding
- Keywords
- Small bowel capsule endoscopy, Obscure gastrointestinal bleeding, Bowel preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Other government
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 1 Dec 2021 (actual)
- 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.
Small bowel capsule endoscopy (SBCE) has become an important tool in clinical practice since its introduction in 2000. This non-invasive method allows the visualization of small bowel mucosa, being essential in the management of many conditions, such as suspected small bowel bleeding, inflammatory bowel diseases and intestinal polyposis syndromes. Despite recommendations concerning SBCE in different pathologies, there are still some technical concerns to be addressed. The optimal preparation for SBCE has been one of these controversial issues.
Currently, the European Society of Gastrointestinal Endoscopy (ESGE) recommends that patients ingest a purgative agent (2L of polyethylene glycol, PEG) and antifoaming agents for SBCE, because it was associated with a better visualization. However, it remains unclear which is the optimal timing for purgative use. Furthermore, the use of a booster agent after capsule ingestion is already performed in colon capsule endoscopy, but less is known about its application in SBCE. Also, it remains to be clarified whether a better visualization results in higher diagnostic yield and impacts patients' outcomes.
Therefore, the global aim of this prospective, randomized, multi-centric study is to determine the optimal timing and preparation for small-bowel capsule endoscopy (regardless of the equipment used), comparing four groups of different preparation protocols:
- Protocol 1) 1L of Moviprep® solution the night before the procedure
- Protocol 2) 1L of Moviprep® solution up to 2h before the procedure
- Protocol 3) 0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum (assessed with real-time viewer)
- Protocol 4) 1L of Moviprep® solution after the capsule had reached the duodenum (assessed using real-time viewer)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Protocol 1 | Experimental | Combination Product: Moviprep1L of Moviprep® solution the night before the procedure |
| Protocol 2 | Experimental | Combination Product: Moviprep1L of Moviprep® solution up to 2h before the procedure |
| Protocol 3 | Experimental | Combination Product: Moviprep0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum |
| Protocol 4 | Experimental | Combination Product: Moviprep1L of Moviprep® solution after the capsule had reached the duodenum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be 18 years old or older
- Present OGIB (either occult or overt)
- Agree with study's procedures and have signed the informed consent for the study and SBCE, prior to SBCE procedure
Key exclusion criteria (9 listed)
- Patients performing capsule endoscopy in urgent setting for overt obscure GI bleeding
- Inpatients or bedridden
- History of surgery of the esophagus, stomach, small bowel, or colon
- History of abdominal or pelvic radiation therapy
- Suspected or confirmed stenosis or occlusion
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 |
|---|---|---|
| MoviprepBowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings | Combination product | Protocol 1, Protocol 2, Protocol 3, Protocol 4 |
Primary outcome
Diagnostic yield
Time frame: During the procedure
Proportion of SBCE with positive findings. findings will be classified based on the Saurin classification; the investigators will consider a positive SBCE when lesions classified as P2 or active bleeding are detected (Saurin classification, Table 2), the remaining will be classified as negative
Adequate cleansing rate
Time frame: During the procedure
A cutoff value of quantitative index ≥ 8 points
7 secondary outcomes
Proportion of SBCE with vascular lesions
Time frame: During the procedure
Proportion of SBCE with active bleeding
Time frame: During the procedure
Diagnostic yield per tertile
Time frame: During the procedure
Transit times
Time frame: During the procedure
Symptoms experienced during SBCE procedure
Time frame: During the procedure
Overall patients' satisfaction with the cleansing regimen
Time frame: During the procedure
Small bowel cleansing
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moviprep in people with Obscure Gastrointestinal Bleeding, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 1 site in Portugal.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2021.