If Chronic Gallbladder Diseases Increase the Incidence of PEC

Cholecystitis Clinical Trial

Official title:

If Chronic Gallbladder Diseases Increase the Occurence of Post Endoscopic Retrograde Choledochopancreatography Choledocholithiasis（a Prospective Multi-center Cohort Study）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04242394
• Other study ID #: Chronic gallbladder disease
• Status: Recruiting
• Start date: February 14, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Wenbo Meng, M.D., Ph. D.
• Phone: +8613919177177
• Email: mengwb[@]lzu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multi-centre trial conducts at 4 ERCP centers in China designed to determine if chronic gallbladder diseases increase the incidence of Post-Endoscopic Retrograde Choledochopancreatography-Choledocholithiasis (PEC）

Description:

Endoscopic Retrograde Choledochopancreatography(ERCP) has the advantages of less injury and faster recovery for common bile duct stone patients. However, according to our retrospective study, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis which often requires emergency intervention, when patients combined with chronic gallbladder diseases, such as chronic cholecystitis, asymptomatic gallstones, and gallbladder wall thickness, the incidence of PEC will increase accordingly. The aim of this study is to observe if chronic gallbladder disease will increase the occurence of PEC and develop a high-risk PEC model.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• ERCP patients with gallbladder in situ

Exclusion Criteria:

• Acute cholecystitis before surgery
• Gallbladder has been removed
• Gastrointestinal reconstruction
• Unwillingness or inability to consent for the study
• Unstable vital signs Coagulation dysfunction (INR>1.5)
• Low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs
• 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
• Gallbladder Diseases

Intervention

Procedure:
• ERCP
Routine ERCP procedures with gallbladder in situ patient

Locations

Country	Name	City	State
China	Chinese herb medicine hospital of Longnan City	Longnan	Gansu
China	The first hospital of Tianshui	Tianshui	Gansu
China	Wuwei turmour hospital	Wuwei	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (2)

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/s12876-019-1053-6. — View Citation

Cao J, Peng C, Ding X, Shen Y, Wu H, Zheng R, Wang L, Zou X. Risk factors for post-ERCP cholecystitis: a single-center retrospective study. BMC Gastroenterol. 2018 Aug 22;18(1):128. doi: 10.1186/s12876-018-0854-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Acute PEC(post-ERCP-cholecystitis )	When the PEC occurs, with right upper abdominal pain, White Blood Cell increasing, gallbladder wall =4mm or crudely, temperature might be more than 38 degree centigrade	1month
Secondary	Number of Pancreatitis	Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.	1month
Secondary	Number of Cholangitis	Temperature should be more than 38 #, right upper abdominal pain, chills or WBC=10	1 month
Secondary	Number of Perforation	Typical abdominal pain,abdominal muscle tension, tenderness, evidence of free gas in abdominal cavity	1 month