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

NCT ID: NCT05321472

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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Endoscopic Retrograde Cholangiopancreatography (ERCP) is an operation with high risk. Common bile duct stone and stenosis are important indications. The quality control of ERCP is the key to improve its success rate and reduce complications, which has received great attention. In 2015, the American Society of Gastrointestinal Endoscopy/American College of Gastroenterology (ASGE/ACG) issued ERCP quality control indicators, among which biliary stent placement and radiographic fluoroscopy time are important intraoperative quality control indicators.

The selection of appropriate biliary stent size is not only conducive to successful stent implantation but also to improve the prognosis of patients. Choose a stent of appropriate length. The proximal side of the stent should be 1cm above the obstruction segment, and the distal tail should be located just outside the nipple. The length of the stent can be determined by measuring the distance between the proximal end of the obstruction and the nipple under X-ray.

Current stent size selection is based on the operator's empirical estimation :(1) estimate the distance by endoscope diameter or cone length or catheter marking; (2) By retracting the guidewire, calculate the distance of the guidewire retracting between two points to estimate the length of the stent.The long radiation exposure time results in unnecessary injuries to both the operator and the patient.

Conditions

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Stenosis of Bile Duct Endoscopic Retrograde Cholangiopancreatography

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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group for training the algorithm

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

No interventions assigned to this group

group for testing the algorithm

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years old who underwent ERCP

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice President of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD, PhD

Role: STUDY_CHAIR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology,QiLu Hospital,Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, MD, PhD

Role: CONTACT

053182169385

Rui Ji, MD, PhD

Role: CONTACT

18560086103

Facility Contacts

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Rui Ji, MD, PhD

Role: primary

18560086103

References

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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.

Reference Type BACKGROUND
PMID: 25480099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32838430 (View on PubMed)

Other Identifiers

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2021-SDU-QILU-090

Identifier Type: -

Identifier Source: org_study_id

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