a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication

Machine Learning for the Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication Risk

To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP

Study Overview

• Status: Recruiting
• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Intervention / Treatment: Other: collection of laboratory test results, imaging results and symptoms

Detailed Description

To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP based on machine learning

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• China
  • Hunan
    • Hengyang, Hunan, China
      • Recruiting
      • The First Affiliated Hospital of University of South China
      • Contact: Chen Guodong, PhD; Phone Number: 15211450345; Email: Chenguodong@usc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Routine ERCP patients

Description

Inclusion Criteria:

• Routine ERCP patients

Exclusion Criteria:

• Unwillingness or inability to consent for the study
• Pregnant women or breastfeeding
• current acute pancreatitis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERCP; The postoperative laboratory test results, imaging results and symptoms were collected	Other: collection of laboratory test results, imaging results and symptoms; collection of laboratory test results, imaging results and symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Pancreatitis	Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Cholangitis	Temperature should be more than 38 celsius degree, chills, with right upper abdominal pain, blood routine showing the total amount of the White Blood Cell (WBC), and the amount of polymorphonuclear neutrophil(PMN) are above normal	1 month
Number of Participants with Perforation	Typical abdominal pain,abdominal muscle tension, and there are also radiographic evidence suggesting	1 month
Number of Participants with bile duct stents	If it is necessary to get the patients drainage, Number of Participants with stents or endoscopic nasobiliary drainage (ENBD) should be recorded	1 month
Number of Acute PEC(post-ERCP-cholecystitis )	Number of Acute PEC(post-ERCP-cholecystitis )	1 month

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of University of South China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024ll0204001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No