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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06321614
Other study ID # 2022098
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 31, 2022
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source The First Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4500
Est. completion date December 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. The hospital imaging system looked for plain abdominal standing films diagnosed as intestinal obstruction or normal between 2022 and 2024 2. Aged 18 to 80 years 3. The main complaint was gastrointestinal symptoms Exclusion Criteria: 1. Image interference, fuzzy performance, difficult to distinguish 2. Non-gastrointestinal symptoms were the main complaint 3. Supine, prone, or lateral decubitus radiography 4. Paralytic obstruction, closed loop obstruction, et al

Study Design


Locations

Country Name City State
China TheFirst Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):202 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic and classification performance Accuracy, Recall, Precision, F1-score and confusion matrix 1 week
Secondary Visualized interpretation of the self-supervised model Grad-CAM and t-SNE to visualize the interpretation of the SSL model 1 week
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