Bowel Obstruction SmallPORTOGRELENCT04880421
Diagnostic Performance of Arterial Time for CT Assessment of Parietal Enhancement Defect for the Diagnosis of Ischemia in Mechanical Small Bowel Occlusions: a Comparative Study With Portal Time
An observational study of Bowel Obstruction Small, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Intestinal obstruction is a frequent cause of emergency room visits and represents about 4-7% of the causes of acute abdominal pain syndrome and up to 30% in adults over 60 years old. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Obstruction Small
- How many people
- 158 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2021to 26 Apr 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients, over 18 years of age, with a diagnosis of mechanical small bowel obstruction on CT and having had a CT scan with at least 3 phases: injection-free, arterial time, portal time, were managed at GHPSJ between April 2014 and December 2019
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient with a diagnosis of mechanical small bowel obstruction on CT performed between April 2014 and December 2019
- Patient who had a CT scan with at least 3 phases: injection-free, arterial time, portal time
- French-speaking patient
Who cannot join
- Patient who did not have surgery within the first 24 hours
- Patient with a history of abdomino-pelvic surgery in the month preceding the scan
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient who objects to the use of his or her data for this research
Trial locations and contacts
1 site in 1 country.
About this study
Intestinal obstruction is a frequent cause of emergency room visits and represents about 4-7% of the causes of acute abdominal pain syndrome and up to 30% in adults over 60 years old.
Although 65 to 80% of patients are treated medically, small bowel obstruction remains a serious pathology, with a high mortality rate that can reach 25% in case of small bowel ischemia. It is necessary to systematically perform a CT scan in the initial workup of small bowel obstructions to confirm the diagnosis, identify the mechanism and detect signs of ischemia that would require emergency surgery.
Read more
The best sign for the diagnosis of ischemia is the defect or asymmetry of parietal enhancement of the dilated small bowel. In the literature, this sign is described almost exclusively at portal time. In case of suspicion of mesenteric ischemia (another serious pathology affecting the small bowel), it is recommended to perform an examination with three acquisitions (without injection, arterial time, and portal time).
The department's experience has shown that arterial time is sometimes more sensitive than portal time for visualizing a parietal enhancement defect of the small bowel in mechanical occlusions.
Very few studies have investigated the diagnostic performance of parietal enhancement asymmetry on arterial time in mechanical occlusions of the small bowel.
- Conditions
- Bowel Obstruction Small
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of arterial versus portal phase in CT for the evaluation of parietal enhancement defect
This ouctome corresponds to the evaluation of the sensitivity, specificity, positive predictive value and negative predictive value of the acquisition for parietal enhancement defect as a sign of ischemia.
Measured: Year 1
Secondary outcomes (1)
Inter-observer reproducibility of parietal enhancement defect analysis at arterial time
This outcome corresponds to the evaluation of the Kappa coefficient of inter-observer reproducibility.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start27 Apr 2021
- Primary completion27 Jun 2021
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bowel Obstruction SmallStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Zins, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880421
- Sponsor's protocol ID
- PORTOGRELE
- Acronym
- PORTOGRELE
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zins M, Millet I, Taourel P. Adhesive Small Bowel Obstruction: Predictive Radiology to Improve Patient Management. Radiology. 2020 Sep;296(3):480-492. doi: 10.1148/radiol.2020192234. Epub 2020 Jul 21.
PubMed 32692296Millet I, Taourel P, Ruyer A, Molinari N. Value of CT findings to predict surgical ischemia in small bowel obstruction: A systematic review and meta-analysis. Eur Radiol. 2015 Jun;25(6):1823-35. doi: 10.1007/s00330-014-3440-2. Epub 2015 Apr 8.
PubMed 25850889Ohira G, Shuto K, Kono T, Tohma T, Gunji H, Narushima K, Imanishi S, Fujishiro T, Tochigi T, Hanaoka T, Miyauchi H, Hanari N, Matsubara H, Yanagawa N. Utility of arterial phase of dynamic CT for detection of intestinal ischemia associated with strangulation ileus. World J Radiol. 2012 Nov 28;4(11):450-4. doi: 10.4329/wjr.v4.i11.450.
PubMed 23251723Chuong AM, Corno L, Beaussier H, Boulay-Coletta I, Millet I, Hodel J, Taourel P, Chatellier G, Zins M. Assessment of Bowel Wall Enhancement for the Diagnosis of Intestinal Ischemia in Patients with Small Bowel Obstruction: Value of Adding Unenhanced CT to Contrast-enhanced CT. Radiology. 2016 Jul;280(1):98-107. doi: 10.1148/radiol.2016151029. Epub 2016 Feb 11.
PubMed 26866378
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Arterial Time for CT Assessment of Parietal Enhancement Defect for the Diagnosis of Ischemia in Mechanical Small Bowel Occlusions: a Comparative Study With Portal Time
- ClinicalTrials.gov ID
- NCT04880421
- Acronym / sponsor ID
- PORTOGRELE / PORTOGRELE
- Conditions
- Bowel Obstruction Small
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 10 May 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.
Intestinal obstruction is a frequent cause of emergency room visits and represents about 4-7% of the causes of acute abdominal pain syndrome and up to 30% in adults over 60 years old.
Although 65 to 80% of patients are treated medically, small bowel obstruction remains a serious pathology, with a high mortality rate that can reach 25% in case of small bowel ischemia. It is necessary to systematically perform a CT scan in the initial workup of small bowel obstructions to confirm the diagnosis, identify the mechanism and detect signs of ischemia that would require emergency surgery.
The best sign for the diagnosis of ischemia is the defect or asymmetry of parietal enhancement of the dilated small bowel. In the literature, this sign is described almost exclusively at portal time. In case of suspicion of mesenteric ischemia (another serious pathology affecting the small bowel), it is recommended to perform an examination with three acquisitions (without injection, arterial time, and portal time).
The department's experience has shown that arterial time is sometimes more sensitive than portal time for visualizing a parietal enhancement defect of the small bowel in mechanical occlusions.
Very few studies have investigated the diagnostic performance of parietal enhancement asymmetry on arterial time in mechanical occlusions of the small bowel.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients, over 18 years of age, with a diagnosis of mechanical small bowel obstruction on CT and having had a CT scan with at least 3 phases: injection-free, arterial time, portal time, were managed at GHPSJ between April 2014 and December 2019
Key inclusion criteria (4 listed)
- Patient whose age is ≥ 18 years
- Patient with a diagnosis of mechanical small bowel obstruction on CT performed between April 2014 and December 2019
- Patient who had a CT scan with at least 3 phases: injection-free, arterial time, portal time
- French-speaking patient
Key exclusion criteria (6 listed)
- Patient who did not have surgery within the first 24 hours
- Patient with a history of abdomino-pelvic surgery in the month preceding the scan
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of arterial versus portal phase in CT for the evaluation of parietal enhancement defect
Time frame: Year 1
This ouctome corresponds to the evaluation of the sensitivity, specificity, positive predictive value and negative predictive value of the acquisition for parietal enhancement defect as a sign of ischemia.
1 secondary outcome
Inter-observer reproducibility of parietal enhancement defect analysis at arterial time
Time frame: Year 1
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 27 Apr 2023.
- Background: PubMed 32692296Zins M, Millet I, Taourel P. Adhesive Small Bowel Obstruction: Predictive Radiology to Improve Patient Management. Radiology. 2020 Sep;296(3):480-492. doi: 10.1148/radiol.2020192234. Epub 2020 Jul 21.
- Background: PubMed 25850889Millet I, Taourel P, Ruyer A, Molinari N. Value of CT findings to predict surgical ischemia in small bowel obstruction: A systematic review and meta-analysis. Eur Radiol. 2015 Jun;25(6):1823-35. doi: 10.1007/s00330-014-3440-2. Epub 2015 Apr 8.
- Background: PubMed 23251723Ohira G, Shuto K, Kono T, Tohma T, Gunji H, Narushima K, Imanishi S, Fujishiro T, Tochigi T, Hanaoka T, Miyauchi H, Hanari N, Matsubara H, Yanagawa N. Utility of arterial phase of dynamic CT for detection of intestinal ischemia associated with strangulation ileus. World J Radiol. 2012 Nov 28;4(11):450-4. doi: 10.4329/wjr.v4.i11.450.
- Background: PubMed 26866378Chuong AM, Corno L, Beaussier H, Boulay-Coletta I, Millet I, Hodel J, Taourel P, Chatellier G, Zins M. Assessment of Bowel Wall Enhancement for the Diagnosis of Intestinal Ischemia in Patients with Small Bowel Obstruction: Value of Adding Unenhanced CT to Contrast-enhanced CT. Radiology. 2016 Jul;280(1):98-107. doi: 10.1148/radiol.2016151029. Epub 2016 Feb 11.
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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.
Marc Zins, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Obstruction Small, run by Fondation Hôpital Saint-Joseph at 1 site 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 4 inclusion and 6 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 27 Apr 2023. 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 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. 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?
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?
Diagnostic performance of arterial versus portal phase in CT for the evaluation of parietal enhancement defect (time frame: Year 1). 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 NCT04880421, which also lists 4 linked publications.
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 27 Apr 2023.