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The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

NCT ID: NCT04234126

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-11-18

Brief Summary

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

Detailed Description

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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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Conditions

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Cholecystitis

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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 .

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Wenbo Meng

M.D., Ph. D, Director of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenbo Meng, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

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Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 31382888 (View on PubMed)

Zhang X, Yue P, Zhang J, Yang M, Chen J, Zhang B, Luo W, Wang M, Da Z, Lin Y, Zhou W, Zhang L, Zhu K, Ren Y, Yang L, Li S, Yuan J, Meng W, Leung JW, Li X. A novel machine learning model and a public online prediction platform for prediction of post-ERCP-cholecystitis (PEC). EClinicalMedicine. 2022 May 13;48:101431. doi: 10.1016/j.eclinm.2022.101431. eCollection 2022 Jun.

Reference Type DERIVED
PMID: 35706483 (View on PubMed)

Other Identifiers

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Gallbladder status and PEC

Identifier Type: -

Identifier Source: org_study_id