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Completed

NCT Number: NCT04234126

The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

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

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP

Procedure

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 .

Primary outcomes

  1. Number of Acute PEC(post-ERCP-cholecystitis )

    Time frame: 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 outcomes

  1. Number of Participants with Pancreatitis

    Time frame: 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.

  2. Number of Participants with Cholangitis

    Time frame: 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

  3. Number of Participants with Perforation

    Time frame: 1 month

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

  4. Number of Participants with bile duct stents

    Time frame: 1 month

    If it is necessary to get the patients drainage, Number of Participants with stents or endoscopic nasobiliary drainage (ENBD) should be recorded

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 21, 2020
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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