Artificial Intelligence-assisted Common Bile Duct Stent Selection in Endoscopic Retrograde Cholangiopancreatography

NCT05321472 | Unknown

• 1 other identifier: 2021-SDU-QILU-090
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Common bile duct stenosis is an important indication for endoscopic retrograde cholangiopancreatography(ERCP). Appropriate selection of bile duct stent size is not only conducive to successful stent implantation but also to improve the prognosis of patients. Currently, the selection of stent specifications is based on the operator's empirical estimation, which is not only not accurate but also increases the radiation exposure time, causing unnecessary harm to both the operator and the patient. Our objective is to develop an artificial intelligence algorithm to automatically select appropriate stent.

Conditions

Stenosis of Bile Duct; Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

• The accuracy of the calculated length of the stents by the artificial intelligence

  The length of the stent was calculated "the length from the stenosis to the papilla+2cm".The length of the stent selected by experts is the gold standard

  6 months

Secondary Outcomes (1)

• The accuracy of the segmentation of the artificial intelligence

  4 months

Study Arms (2)

group for training the algorithm

This group of images is used for training the algorithm of the artificial intelligence

group for testing the algorithm

This group of images is used for testing the algorithm of the artificial intelligence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The eligible images was randomly devided into two groups. One group for training the algorithm and the other group for testing the algorithm.

You may qualify if:

• Patients older than 18 years old who underwent ERCP

You may not qualify if:

• failed cholangiopancreatography caused by failed intubation, gastric retention, duodenal disease and so on
• patients proved no stenosis in common bile duct
• poor cholangiograms due to the lack of contrast agent or insufficient filling of contrast agent (cholangiograms without the completed CBD or thumbnails)

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology,QiLu Hospital,Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (2)

• Adler DG, Lieb JG 2nd, Cohen J, Pike IM, Park WG, Rizk MK, Sawhney MS, Scheiman JM, Shaheen NJ, Sherman S, Wani S. Quality indicators for ERCP. Gastrointest Endosc. 2015 Jan;81(1):54-66. doi: 10.1016/j.gie.2014.07.056. Epub 2014 Dec 2. No abstract available.

  PMID: 25480099 BACKGROUND

• Huang L, Lu X, Huang X, Zou X, Wu L, Zhou Z, Wu D, Tang D, Chen D, Wan X, Zhu Z, Deng T, Shen L, Liu J, Zhu Y, Gong D, Chen D, Zhong Y, Liu F, Yu H. Intelligent difficulty scoring and assistance system for endoscopic extraction of common bile duct stones based on deep learning: multicenter study. Endoscopy. 2021 May;53(5):491-498. doi: 10.1055/a-1244-5698. Epub 2020 Nov 9.

  PMID: 32838430 BACKGROUND

Study Officials

• Yanqing Li, MD, PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Yanqing Li, MD, PhD

CONTACT

053182169385; liyanqing@sdu.edu.cn

Rui Ji, MD, PhD

CONTACT

18560086103; qljirui@email.sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Qilu Hospital

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: April 11, 2022
• Study Start: April 20, 2022
• Primary Completion: August 1, 2022
• Study Completion: April 1, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-05

Locations

CN (1)