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

S

Shandong University

Status

Unknown

Conditions

Endoscopic Retrograde Cholangiopancreatography
Stenosis of Bile Duct

Study type

Observational

Funder types

Other

Identifiers

NCT05321472
2021-SDU-QILU-090

Details and patient eligibility

About

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.

Full description

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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

600 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Rui Ji, MD, PhD; Yanqing Li, MD, PhD

Data sourced from clinicaltrials.gov

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