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

Zhujiang Hospital450 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

450

Conditions

ERCP

Interventions

Erbao electric knifeDEVICE

Erbao electric knife is used to cut the Duodenal sphincter

Three-cavity incision knifeDEVICE

Three-cavity incision knife is used to cut the Duodenal sphincter

Columnar expansion balloonDEVICE

Columnar expansion balloon is used to expand the the Duodenal sphincter

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhujiang Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

the incidence of composite events of infection, hemorrhage, perforation, pancreatitis

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.

Time frame: 3 and 24 hours after the ERCP

Secondary Outcomes

Recurrence rate of bile duct stones

One year after the ERCP,the participants will have a CT scan to find out whether the bile duct stones recur again.

Time frame: 1 year after the ERCP.

Data from ClinicalTrials.gov

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