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The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04234126
Enrollment
1117
Registered
2020-01-21
Start date
2020-01-31
Completion date
2021-11-18
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis

Keywords

ERCP, Acute purulent cholecystitis, Bile duct stone, PEC(post-ERCP-choledocholithiasis)

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. .

Interventions

PROCEDUREERCP

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 .

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Acute PEC(post-ERCP-cholecystitis )1 monthWhen 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

MeasureTime frameDescription
Number of Participants with Pancreatitis1 monthTypical 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 Cholangitis1 monthTemperature 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 Perforation1 monthTypical abdominal pain,abdominal muscle tension, and there are also radiographic evidence suggesting
Number of Participants with bile duct stents1 monthIf it is necessary to get the patients drainage, Number of Participants with stents or endoscopic nasobiliary drainage (ENBD) should be recorded

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026