The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

Hepatopancreatobiliary Surgery Institute of Gansu Province1,117 enrolled

Overview

In this retrospective study, the investigators evaluate the relationship of post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor.

When patients have common bile duct(CBD) stones, ERCP is widely used for stone extraction instead of clinical operation. ERCP has many advantages like less injury or faster recovery. However, according to literature, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis, which often requires emergency intervention, therefore, it is necessary to know if the gallbladder status(chronic disease) is one of the important risk factors of PEC like the gallbladder wall thickness, chronic cholecystitis, polyps,crudely or calculus. .

Study Type

OBSERVATIONAL

Enrollment

1,117

Conditions

Cholecystitis

Interventions

ERCPPROCEDURE

Routine ERCP for CBD stone with the gallbladder in situ, the chronic gallbladder status was defined as gallbladder wall thickness≥4mm, chronic cholecystitis, polyps,crudely or calculus .

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Routine ERCP for CBD stone patients with gallbladder in situ Exclusion Criteria: * Unwillingness or inability to consent for the study * Unstable vital signs Coagulation dysfunction (INR\>1.5) and low peripheral blood platelet count (\<50×10 \^9 / L) or using anti-coagulation drugs * Any Prior surgery for CBD including ERCP * Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock * Biliary- duodenal fistula confirmed during ERCP * Pregnant women or breastfeeding

Locations (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Outcomes

Primary Outcomes

Number of Acute PEC(post-ERCP-cholecystitis )

When the PEC occurs, the temperature should be more than 38 celsius degree, right upper abdominal pain, the total amount of the White Blood Cell (WBC) is above normal for the patients who with the gallbladder wall thickness under ultrasound examination.

Time frame: 1 month

Secondary Outcomes

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.

Time frame: 1 month

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

Time frame: 1 month

Number of Participants with Perforation

Typical abdominal pain,abdominal muscle tension, and there are also radiographic evidence suggesting

Time frame: 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

Time frame: 1 month

Data from ClinicalTrials.gov

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