Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04903444 |
| Other study ID # |
EA-19-003-22 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 27, 2021 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
May 2021 |
| Source |
Renmin Hospital of Wuhan University |
| Contact |
Honggang Yu, Doctor |
| Phone |
+862788041911 |
| Email |
whdxrmyy[@]126.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, the investigators proposed an artificial intelligence-based biliary stricture
navigation system in MRCP-based ERCP, which can instruct the direction of guide wire and the
position of stent placement in real time.
Description:
585/5000 Biliary stricture can be divided into benign biliary stricture and malignant biliary
stricture, and malignant hilar biliary obstruction is the one of the common cause. Since
there is no specific early screening method for malignant hilar biliary obstruction at
present and most patients have no obvious clinical symptoms in the early stage, most patients
are already in the advanced stage when they are first diagnosed. Advanced malignant hilar
biliary obstruction cannot undergo resection surgery, whose first choice for the treatment is
palliative endoscopic biliary drainage.Biliary drainage can relieve jaundice, pruritus and
other symptoms due to cholestasis. However,before the narrow segment was placed the stent,
the contrast agent could not pass through the narrow segment and the bile duct above the
narrow segment could not be seen.So it was difficult for doctors to determine the direction
of the guide wire and the position of the stent. In addition, indiscriminate application of
the contrast agent may cause outflow obstruction leading to infection. However, there is no
relevant research to solve these problems.
MRCP is the preferred examination method of pancreatic and bile duct diseases. Therefore,
MRCP should be routinely performed before patients are treated with ERCP. At present, MRCP is
in supine position, and ERCP is in prone position. Different positions lead to differences in
the morphology of MRCP and the bile duct on ERCP.So preoperative MRCP in supine position has
limited role in advising physicians on the morphology of the bile duct. Therefore, MRCP in
the prone position is more favorable for endoscopists to perform ERCP .
In recent years, deep learning algorithms have been continuously developed and increasingly
mature.They have been gradually applied to the medical field. Computer vision is a science
that studies how to make machines "see". Through deep learning, camera and computer can
replace human eyes to carry out machine vision such as target recognition, tracking and
measurement.Interdisciplinary cooperation in the field of medical imaging and computer vision
is also one of the research hotspots in recent years. At present, it is mainly applied to the
automatic identification and detection of lesions and quality control, and has achieved good
results. It can assist doctors to find lesions, make disease diagnosis and standardize
doctors' operations, so as to improve the quality of doctors' operations.With mature
technical support, it has a good prospect and application value to develop endoscopic
operating system for lesion detection and quality control based on artificial intelligence
methods such as deep learning.
In this study, the investigators proposed an artificial Intelligence-based Biliary Stricture
Navigation System in MRCP-based ERCP, which can instruct the direction of guide wire and the
position of stent placement in real time.
