A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP

Not Applicable

• Conditions: ERCP

• Registration Number: NCT03416205
• Lead Sponsor: Zhujiang Hospital

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones.

Detailed Description

Investigators first divided the patients with different sizes of common bile duct stones into two groups. The bile duct stone diameter of group A is less than 1.0cm while group B is more than 1.0cm and less than 1.5cm. Each group compared Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) in ERCP. Through the postoperative comparison of relevant inspection test indicators, the recovery of patients, whether the occurrence of complications, including infection,bleeding,pancreatitis,perforation , and 1 year stone recurrence rate,Investigators assess the advantages and disadvantages in three different strategies in different sizes of common bile duct stones , and finally get a relatively objective evaluation to guide our daily ERCP work on the choice of duodenal papillary sphincter treatment strategy.

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-15
• Study Start: 2017-07-20
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-31
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Age 20-80 years old
• CT or MRCP diagnose the patients with Common bile duct stones
• The diameter of the stone is less than or equal to 1.5cm
• Patients with the indications for ERCP
• Patients and their families agree to participate in the trial

Exclusion Criteria

• Stones are too large (> 1.5cm)
• A history of gastrointestinal surgery
• ERCP and EST or EPBD surgery history
• Patients generally poor, total bilirubin> 200umol / L or PT time extension> 3s
• Patients with mental illness or other serious heart and lung disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the incidence of composite events of infection, hemorrhage, perforation, pancreatitis	3 and 24 hours after the ERCP	Investigators comprehensively assess whether the hemorrhage, perforation, pancreatitis and other complications of retrograde cholangiopancreatography (ERCP) happen or not by clinical sympton and blood index 1 day after the ERCP. The blood index includes CRP, amylase,lipase,leukocyte,red blood cell,hemoglobin.Besides,CT will be done if necessary.Finally investigators use statistical method to analyse the incidence of composite events of infection, hemorrhage, perforation, pancreatitis.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate of bile duct stones	1 year after the ERCP.	One year after the ERCP,the participants will have a CT scan to find out whether the bile duct stones recur again.

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China