The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

Cholecystitis Clinical Trial

Official title:

Does the Gallbladder Status Influence the Occurence of Post-Endoscopic Retrograde Choledochopancreatography(ERCP) -Choledocholithiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234126
• Other study ID #: Gallbladder status and PEC
• Status: Completed
• Start date: January 31, 2020
• Est. completion date: November 18, 2021

Study information

• Verified date: November 2021
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 1117
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Choledocholithiasis

Intervention

Procedure:
• ERCP
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 .

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (1)

Cao J, Ding X, Wu H, Shen Y, Zheng R, Peng C, Wang L, Zou X. Classification of the cystic duct patterns and endoscopic transpapillary cannulation of the gallbladder to prevent post-ERCP cholecystitis. BMC Gastroenterol. 2019 Aug 5;19(1):139. doi: 10.1186/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	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.	1 month
Secondary	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	1 month
Secondary	Number of Participants with Perforation	Typical abdominal pain,abdominal muscle tension, and there are also radiographic evidence suggesting	1 month
Secondary	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	1 month