Design and Validation of a Convolutional Neural Network to Predict Difficult Biliary Canulation: a Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- To train a convolutional neural network to predict difficult biliary canulation
研究概览
简要总结
The main purpose of the study is to train a convolutional neural network (CNN) to predict difficult biliary canulation (DBC) following the European Society of Gastrointestinal Endoscopy Society (ESGE). Consecutive patients undergoing an endoscopic retrograde cholangiopancreatography (ERCP) will be included in the study. Several pictures of the second portion of the duodenum including the ampulla will be taken, along with several pictures of the radiological image. Pictures prospectively collected from the study PRECABIDO (NCT06591364), a multicenter study whith the purpose of evaluating the prevalence of difficult biliary cannulation and predictive factors for difficult cannulation and cannulation failure using ESGE criteria were also used for the training of the CNN.
We will also assess:
A validation of the CNN assessing the agreement between ESGE criteria and the CNN prediction.
To design a novel application based on the use of a convolutional neural network (CNN) to detect difficult biliary cannulation.
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详细描述
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the indication for the procedure, and technical variables.
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience. All patients, except in cases of allergy, will receive 1 suppository of indomethacin or diclofenac before the procedure. In cases of allergy, pre-procedure hydration with Ringer's lactate will be administered if there is no contraindication (consider the protocol proposed by the ESGE: 3 mL/kg/hour during ERCP, 20 mL/kg as a bolus after ERCP, and 3 mL/kg/hour for 8 hours post-ERCP). The use of a pancreatic stent should be considered when indicated.
After the procedure, patients will remain hospitalized for at least 24 hours in the hospital. The patient's medical record will be reviewed 7 days after the procedure to check for any adverse effects, and a follow-up phone call will be made to detect any adverse effects.
Initially, a pilot study will be conducted with 600 patients, assessing based on the results-that is, the percentage of patients with difficult cannulation. At the beginning of the examination, at least three endoscopic images and three radiological images of the second portion of the duodenum will be captured for each patient. In patients undergoing endoscopic ultrasound (EUS), three additional images of the second portion of the duodenum at the level of the pancreatic head and common bile duct (CBD) will be obtained.
These images will be labeled as "CBD yes" or "CBD no" according to ESGE criteria, which will serve as the gold standard. Once labeled, the images will be used to train a convolutional neural network (CNN) capable of predicting, just before attempting biliary cannulation, whether it will be a CBD or not.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Signed informed consent
- •Patients indicated for ERCP
排除标准
- •INR > 1.5
- •Platelets < 50,000/mm³
- •Patients with a prior endoscopic sphincterotomy
- •Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
- •Known pancreas divisum
- •Indication due to pancreatic duct pathology
研究组 & 干预措施
Patients undergoing ERCP
Consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) will be included
干预措施: Endoscopic retrograde cholangiopancreatography (ERCP) (Procedure)
结局指标
主要结局
To train a convolutional neural network to predict difficult biliary canulation
时间窗: 1 year
To train a convolutional neural network to predict difficult biliary canulation following the European Society of Gastrointestinal Endoscopy Society (ESGE): Assessment of difficult biliary cannulation defined by ESGE criteria (\> 5 minutes duration until cannulation, \> 5 cannulation attempts, \> 1 passage of the guidewire into the main pancreatic duct). Based on these criteria pictures will be labelled as difficult biliary cannulation or not
次要结局
- A validation of the CNN(1 year)
研究者
Manuel Hernandez-Guerra, MD
MD, PhD
University of La Laguna