Skip to main content
OpenTrials
Completed

NCT Number: NCT04173624

To Compare EUS and MRCP in Detecting Choledocholithiasis in Patients of Intermediate Risk of Choledocholithiasis

A Recent Meta analysis, showed pooled sensitivity and specificity were 97% and 90 for EUS and 87% and 92 for MRCP . This meta analysis includes only 5 studies, smaller sample size in each study, significant heterogeneity in reference standards ranged from ERCP and Intra operative cholangiography (IOC) to clinical follow up for negative patients . Furthur validation of EUS Vs MRCP is needed in detecting common bile duct caliculi in intermediate risk of choledocholithiasis To date Randamized control trail comparing EUS Vs MRCP in detecting Choledocholithiasis lacking , hence the investigators aimed a Randamized control trail determining and comparing the sensitivity and specificity of EUS and MRCP in diagnosing Choledocholithiasis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Choledocholithiasis Bile Duct Diseases Biliary Tract Diseases Cholelithiasis Common Bile Duct Diseases Digestive System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

About this study

Aim: Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial

Outcomes

A.Primary Outcome :

•Sensitivity and Specificity of EUS Vs MRCP

B.Secondary Outcomes:

  • Cost effectiveness
  • Adverse effects
  • Additional Clinically Significant endoscopic findings

MATERIAL AND METHODS Study area •out-patients and in-patients in Asian Institute of Gastroenterology Study design Randamized control study Study period November 2019-March 2020

Inclusion criteria

•Patients over 18yrs of age with suspected choledocholithiasis stratified into intermediate risk of choledocholithiasis as per European Society of Gastrointestinal Endoscopy Guidelines Guidelines

Exclusion criteria

  • Patients with Cholangitis
  • Patients with hypotension
  • Ultrasound or CT cross sectional image showing stone
  • Patients with contraindications to MRCP (claustrophobia ,pacemaker, or any prosthesis contraindicating MR)
  • Predictable impossibility to perform a complete exploration of pancreato biliary area by EUS (gastroenteroanastomosis or stenosis )
  • Patients with suspected pancreato biliary malignancy or pancreato biliary malformations
  • Patients with history significant alcohol intake
  • Patients taking hepato toxic drugs
  • Patients in whom serum hepatitis B or C antibodies are present
  • Patients with confirmed history of choledocholithiasis or history of biliary sphincterotomy
  • Patients not giving consent for participation

STUDY PROCEDURE The study will be a Randomized control study where sensitivity and specificity and secondary outcomes - cost effectiveness, adverse effects will be compared between EUS and MRCP group . All the patients presented to outpatient department or in patient wards with suspected choledocholithiasis will be screened as per European Society of Gastrointestinal Endoscopy guideline. Patients stratified into intermediate probability will be selected based on inclusion and exclusion criteria. Then patients will randomized to either EUS or MRCP based computerized software .Patients who are randomized to EUS group will undergo EUS for detection of Choledocholithiasis and then undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) at same time if calculi detected and patients in whom calculi was not found, management is based on clinical judgement and 3months follow up . Patients who are randomized to MRCP group will undergo MRCP for detection of Choledocholithiasis and then undergo ERCP if calculi detected. Patients in whom calculi was not found, management will be based on clinical judgement and 3 months follow up. Based on presence of or absence of stone in Reference standard i.e in ERCP following EUS or MRCP or during 3 month follow up , sensitivities and specificities of EUS and MRCP are calculated and compared .

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients over 18yrs of age with suspected choledocholithiasis stratified into intermediate risk of choledocholithiasis as per European Society of Gastrointestinal Endoscopy Guidelines

Exclusion criteria

  • Patients with Cholangitis
  • Patients with hypotension
  • Ultrasound or CT cross sectional image showing stone
  • Patients with contraindications to MRCP (claustrophobia ,pacemaker, or any prosthesis contraindicating MR)
  • Predictable impossibility to perform a complete exploration of pancreato biliary area by EUS (gastroenteroanastomosis or stenosis )
  • Patients with suspected pancreato biliary malignancy or pancreato biliary malformations
  • Patients with history significant alcohol intake
  • Patients taking hepato toxic drugs
  • Patients in whom serum hepatitis B or C antibodies are present
  • Patients with confirmed history of choledocholithiasis or history of biliary sphincterotomy
  • Patients not giving consent for participation

Treatment and study plan

Endosonography

Diagnostic Test

Endosonography (EUS) is endoscopic method for evaluated pancreatic and biliary pathology.

Magnetic Resonance Cholangiopancreatography

Diagnostic Test

Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for evaluating pancreatic and biliary pathology

Primary outcomes

  1. Sensitivity and Specificity of EUS Vs MRCP

    Time frame: 4 month

    This study will evaluate diagnostic accuracy of MRCP and EUS in patients with intermediate probability of choledocholithiasis as per European society of GI endoscopy guidelines

Secondary outcomes

  1. Rate of Adverse Events

    Time frame: 4 month

    Adverse events related with EUS and MRCP will be collected. Those who undergo ERCP for choledocholithiasis, total adverse events related to ERCP will be collected.

  2. Cost - Effectiveness

    Time frame: 4 months

    Cost benefits analysis for EUS Vs MRCP will be done for detection of choledocholithiasis by using total cost along with direct and indirect cost.

  3. Rate of Additional Significant Endoscopic finding

    Time frame: 4 months

    In Endosonography arm, total additional endoscopic clinically significant findings such as ulcer, polyps, esophageal and gastric varies, gastric outlet obstruction will be collected.

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 22, 2019
Registry last updated
Aug 18, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.