The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

Completed

• Conditions: Cholecystitis

• Registration Number: NCT04234126
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary

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

Detailed Description

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.

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Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Study Start: 2020-01-31
• Status Verified: 2021-11
• Primary Completion: 2021-11-18
• Study Completion: 2021-11-18
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Acute PEC(post-ERCP-cholecystitis )	1 month	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.

Secondary 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.
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 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)

Hepatopancreatobiliary Surgery Institute of Gansu Province; 🇨🇳 Lanzhou, Gansu, China