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Small Bowel ObstructionSMARTLOOP2NCT05566158

Development and Validation of a CT-based Diagnostic Models Using Artificial Intelligence for Detection of Small Bowel Obstruction

An observational study of Small Bowel Obstruction, run by Fondation Hôpital Saint-Joseph at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Small bowel obstruction (SBO) is a common non-traumatic surgical emergency. All guidelines recommend computed tomography (CT) as the first-line imaging test for patients with suspected SBO. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Bowel Obstruction
How many people
8,000 participants
Where
2 sitesFrance
Study dates
9 Aug 2022to 31 Dec 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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient whose age ≥ 18 years, who has had a CT scan with at least one abdominal-pelvic acquisition performed within the Saint Joseph Hospital Group with a report containing the terms "occlusion" or "occlusive", "vomiting" or "ileus".

Who may be able to join

  • Patient whose age ≥ 18 years
  • Patient who has had a CT scan with at least one abdominal-pelvic acquisition performed within the Saint Joseph Hospital Group
  • Report containing the terms "occlusion" or "occlusive", "vomiting" or "ileus"
  • French-speaking patient

Who cannot join

  • Imaging not usable
  • Absence of abdomino-pelvic volume on CT acquisitions
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his data for this research

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Central for Visual Computing - OPIS Inria group

    Gif-sur-Yvette

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

Other trials in France

About this study

Small bowel obstruction (SBO) is a common non-traumatic surgical emergency. All guidelines recommend computed tomography (CT) as the first-line imaging test for patients with suspected SBO. The objectives of CT are multiple: (i) to confirm or refute the diagnosis of GI obstruction, defined as distension of the digestive tracts greater than 25 mm, and, when SBO is present, (ii) to confirm the mechanism (mechanical vs. functional), (iii) to localize the site of obstruction, i.e., the transition zone (TZ), (iv) to identify the cause, and (v) to look for complications such as strangulation or perforation, influencing management.

Given the exponential increase in the number of scans being performed, especially in the setting of emergency management, methods to assist the radiologist would be useful to:

Read more
  1. Sort the scans performed, allowing prioritization of the analysis of scans with a higher probability of pathology (occlusion in our case)
  2. Help the radiologist to diagnose occlusion and its type (functional or mechanical), and to identify signs of severity.
  3. To help the emergency physician and the digestive surgeon to make a decision on the management of the disease (surgical or medical).

Machine learning has developed rapidly over the last decades, first thanks to the increase in data storage capacities, then thanks to the arrival of parallel processing hardware based on graphic processing units, in the context of radiological diagnostic assistance. Consequently, the number of studies on deep neural networks in medical imaging is increasing rapidly. However, few teams focus on SBO. The only published classification models have been produced for standard abdominal radiographs. No studies have used CT or 3D models, apart from our preliminary study on ZTs, despite the recognized advantages of CT for the diagnosis of SBO and the likely contribution of 3D models, which may be comparable to that of multiplanar reconstruction for the analysis of images in multiple planes of space.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Automated detection of digestive occlusions

    This outcome corresponds to the ability of the model to identify the presence or absence of occlusion: sensitivity, specificity and predictive values.

    Measured: Year 1

Secondary outcomes (4)

  1. Automatic differentiation of functional vs. mechanical occlusions

    This outcome corresponds to the detection of functional vs. mechanical occlusions.

    Measured: Year 1

  2. Algorithm for surgical indication

    This outcome corresponds to the performance of the clinical-radio-biological algorithm for prediction of surgery.

    Measured: Year 1

  3. Analysis via radiomics of junction zones

    This outcome corresponds to the analysis via radiomics of the junction zones of mechanical digestive occlusions (the junction zones are the zones where the dilation-flat transition is located, thus the zone where the obstruction is located):

    • Adhesions vs. flanges: new radiological signs?
    • Improved performance of surgery prediction.

    Measured: Year 1

  4. Automated detection of junction areas

    This outcome corresponds to the performance of automatic detection in identifying the junction zones of mechanical digestive obstructions.

    Measured: Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start9 Aug 2022
  3. Primary completion9 Sep 2022
  4. Study completion31 Dec 2023 (estimated)

Resources

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
8,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566158
Sponsor's protocol ID
SMARTLOOP2
Acronym
SMARTLOOP2
Status last verified
Sep 2022
First submitted
30 Sep 2022
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ten Broek RPG, Krielen P, Di Saverio S, Coccolini F, Biffl WL, Ansaloni L, Velmahos GC, Sartelli M, Fraga GP, Kelly MD, Moore FA, Peitzman AB, Leppaniemi A, Moore EE, Jeekel J, Kluger Y, Sugrue M, Balogh ZJ, Bendinelli C, Civil I, Coimbra R, De Moya M, Ferrada P, Inaba K, Ivatury R, Latifi R, Kashuk JL, Kirkpatrick AW, Maier R, Rizoli S, Sakakushev B, Scalea T, Soreide K, Weber D, Wani I, Abu-Zidan FM, De'Angelis N, Piscioneri F, Galante JM, Catena F, van Goor H. Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2017 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. World J Emerg Surg. 2018 Jun 19;13:24. doi: 10.1186/s13017-018-0185-2. eCollection 2018.

    PubMed 29946347

  • Expert Panel on Gastrointestinal Imaging; Chang KJ, Marin D, Kim DH, Fowler KJ, Camacho MA, Cash BD, Garcia EM, Hatten BW, Kambadakone AR, Levy AD, Liu PS, Moreno C, Peterson CM, Pietryga JA, Siegel A, Weinstein S, Carucci LR. ACR Appropriateness Criteria(R) Suspected Small-Bowel Obstruction. J Am Coll Radiol. 2020 May;17(5S):S305-S314. doi: 10.1016/j.jacr.2020.01.025.

    PubMed 32370974

  • Frager D, Medwid SW, Baer JW, Mollinelli B, Friedman M. CT of small-bowel obstruction: value in establishing the diagnosis and determining the degree and cause. AJR Am J Roentgenol. 1994 Jan;162(1):37-41. doi: 10.2214/ajr.162.1.8273686.

    PubMed 8273686

  • Montagnon E, Cerny M, Cadrin-Chenevert A, Hamilton V, Derennes T, Ilinca A, Vandenbroucke-Menu F, Turcotte S, Kadoury S, Tang A. Deep learning workflow in radiology: a primer. Insights Imaging. 2020 Feb 10;11(1):22. doi: 10.1186/s13244-019-0832-5.

    PubMed 32040647

  • Cheng PM, Tejura TK, Tran KN, Whang G. Detection of high-grade small bowel obstruction on conventional radiography with convolutional neural networks. Abdom Radiol (NY). 2018 May;43(5):1120-1127. doi: 10.1007/s00261-017-1294-1.

    PubMed 28828625

  • Kim DH, Wit H, Thurston M, Long M, Maskell GF, Strugnell MJ, Shetty D, Smith IM, Hollings NP. An artificial intelligence deep learning model for identification of small bowel obstruction on plain abdominal radiographs. Br J Radiol. 2021 Jun 1;94(1122):20201407. doi: 10.1259/bjr.20201407. Epub 2021 Apr 27.

    PubMed 33904763

  • Vanderbecq Q, Ardon R, De Reviers A, Ruppli C, Dallongeville A, Boulay-Coletta I, D'Assignies G, Zins M. Adhesion-related small bowel obstruction: deep learning for automatic transition-zone detection by CT. Insights Imaging. 2022 Jan 24;13(1):13. doi: 10.1186/s13244-021-01150-y.

    PubMed 35072813

  • Hodel J, Zins M, Desmottes L, Boulay-Coletta I, Julles MC, Nakache JP, Rodallec M. Location of the transition zone in CT of small-bowel obstruction: added value of multiplanar reformations. Abdom Imaging. 2009 Jan-Feb;34(1):35-41. doi: 10.1007/s00261-007-9348-4.

    PubMed 18172705

Questions about this trial

What is this clinical trial studying?

An observational study of Small Bowel Obstruction, run by Fondation Hôpital Saint-Joseph at 2 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 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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?

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?

Automated detection of digestive occlusions (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 NCT05566158, which also lists 8 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 4 Oct 2022.

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