a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication

Recruiting

• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Interventions: Other: collection of laboratory test results, imaging results and symptoms

• Registration Number: NCT06277414
• Lead Sponsor: The First Affiliated Hospital of University of South China

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Routine ERCP patients

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERCP	collection of laboratory test results, imaging results and symptoms	The postoperative laboratory test results, imaging results and symptoms were collected

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Cholangitis	1 month	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
Number of Acute PEC(post-ERCP-cholecystitis )	1 month	Number of Acute PEC(post-ERCP-cholecystitis )
Number of Participants with Perforation	1 month	Typical abdominal pain,abdominal muscle tension, and there are also radiographic evidence suggesting
Number of Participants with bile duct stents	1 month	If it is necessary to get the patients drainage, Number of Participants with stents or endoscopic nasobiliary drainage (ENBD) should be recorded

Trial Locations

Locations (1)

The First Affiliated Hospital of University of South China; 🇨🇳 Hengyang, Hunan, China