NCT06321614

Brief Summary

Background: Accurate labeling of obstruction site on upright abdominal radiograph is a challenging task. The lack of ground truth leads to poor performance on supervised learning models. To address this issue, self-supervised learning (SSL) is proposed to classify normal, small bowel obstruction (SBO), and large bowel obstruction (LBO) radiographs using a few confirmed samples. Methods: A few number of confirmed and a large number of unlabeled radiographs were categorized based on the ground truth. The SSL model was firstly trained on the unlabeled radiographs, and then fine-tuned on the confirmed radiographs. ResNet50 and VGG16 were used for the embedded base encoders, whose weights and parameters were adjusted during training process. Furthermore, it was tested on an independent dataset, compared with supervised learning models and human interpreters. Finally, the t-SNE and Grad-CAM were used to visualize the model's interpretation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

March 13, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

Deep learningArtificial intelligenceMachine learning

Outcome Measures

Primary Outcomes (1)

  • Diagnostic and classification performance

    Accuracy, Recall, Precision, F1-score and confusion matrix

    1 week

Secondary Outcomes (1)

  • Visualized interpretation of the self-supervised model

    1 week

Study Arms (3)

patients with normal abdominal radiographs

patients with normal abdominal radiographs, which were confirmed by extra imaging examinations and clinical data. The imaging examinations comprised CT, magnetic resonance imaging (MRI) and colonoscopy in the subsequent 72 hours, while clinical data included recent hospital admission information and surgical operation notes.

patients with small bowel obstruction radiographs

patients with small bowel obstruction radiographs, which were confirmed by extra imaging examinations and clinical data. The imaging examinations comprised CT, magnetic resonance imaging (MRI) and colonoscopy in the subsequent 72 hours, while clinical data included recent hospital admission information and surgical operation notes. In terms of location, small-bowel obstruction (SBO) involves the duodenum, jejunum, and ileum

patients with large bowel obstruction radiographs

patients with large bowel obstruction radiographs, which were confirmed by extra imaging examinations and clinical data. The imaging examinations comprised CT, magnetic resonance imaging (MRI) and colonoscopy in the subsequent 72 hours, while clinical data included recent hospital admission information and surgical operation notes. In terms of location, large-bowel obstruction (SBO), involves the cecum, colon, and rectum.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

participants received upright abdominal radiographs were included in this study. They can be divided with participants with normal abdominal radiographs, participants with small bowel obstruction, and participants with large bowel obstruction. The study strictly follow the inclusion and exclusion criteria.

You may qualify if:

  • The hospital imaging system looked for plain abdominal standing films diagnosed as intestinal obstruction or normal between 2022 and 2024
  • Aged 18 to 80 years
  • The main complaint was gastrointestinal symptoms

You may not qualify if:

  • Image interference, fuzzy performance, difficult to distinguish
  • Non-gastrointestinal symptoms were the main complaint
  • Supine, prone, or lateral decubitus radiography
  • Paralytic obstruction, closed loop obstruction, et al

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TheFirst Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Related Publications (9)

  • Markogiannakis H, Messaris E, Dardamanis D, Pararas N, Tzertzemelis D, Giannopoulos P, Larentzakis A, Lagoudianakis E, Manouras A, Bramis I. Acute mechanical bowel obstruction: clinical presentation, etiology, management and outcome. World J Gastroenterol. 2007 Jan 21;13(3):432-7. doi: 10.3748/wjg.v13.i3.432.

  • Cheng PM, Tran KN, Whang G, Tejura TK. Refining Convolutional Neural Network Detection of Small-Bowel Obstruction in Conventional Radiography. AJR Am J Roentgenol. 2019 Feb;212(2):342-350. doi: 10.2214/AJR.18.20362. Epub 2018 Nov 26.

  • 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.

  • Frager D. Intestinal obstruction role of CT. Gastroenterol Clin North Am. 2002 Sep;31(3):777-99. doi: 10.1016/s0889-8553(02)00026-2.

  • Cappell MS, Batke M. Mechanical obstruction of the small bowel and colon. Med Clin North Am. 2008 May;92(3):575-97, viii. doi: 10.1016/j.mcna.2008.01.003.

  • ten Broek RP, Strik C, Issa Y, Bleichrodt RP, van Goor H. Adhesiolysis-related morbidity in abdominal surgery. Ann Surg. 2013 Jul;258(1):98-106. doi: 10.1097/SLA.0b013e31826f4969.

  • 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.

  • Chen Y, Mancini M, Zhu X, Akata Z. Semi-Supervised and Unsupervised Deep Visual Learning: A Survey. IEEE Trans Pattern Anal Mach Intell. 2024 Mar;46(3):1327-1347. doi: 10.1109/TPAMI.2022.3201576. Epub 2024 Feb 6.

  • Li G, Togo R, Ogawa T, Haseyama M. Self-supervised learning for gastritis detection with gastric X-ray images. Int J Comput Assist Radiol Surg. 2023 Oct;18(10):1841-1848. doi: 10.1007/s11548-023-02891-5. Epub 2023 Apr 11.

MeSH Terms

Conditions

Digestive System DiseasesColonic PolypsIntestinal Diseases

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGastrointestinal Diseases

Study Officials

  • Rui Li, MD

    The First Affiliated Hospital of Soochow University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

December 31, 2022

Primary Completion

April 30, 2024

Study Completion

December 31, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations