Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones

January 28, 2016 updated by: Nisa Netinatsunton, Prince of Songkla University

Endoscopic Papillary Large Balloon Dilatation Versus Sphincterotomy +/- Mechanical Lithotripsy for Removal of Bile Duct Stones With a Mean Stone > 20 mm : A Randomized Controlled Study

Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been increasingly accepted as alternative method for removal of large bile duct stones. However, there were limited studies comparing the efficacy of EST in combined with LBD to EST with mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of combined EST- LBD versus EST-ML in the removal of very large bile duct stones.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The large common bile duct stones (CBDS) remains a therapeutic challenge in ERCPs. Large CBDS are generally refractory to be removed by EST and stone extraction balloons and or baskets. Traditional rescue therapy was the technique of stone fragmentation using ML. The previous reports have shown that EST with ML was successful in the fragmentation of large stones yielding stone clearance rate from 68 t0 79 %. EST-LBD has been shown favorable outcome in the treatment of large bile duct stone. A meta-analysis comparing the effectiveness and complications between EST-LBD and EST in the management of CBDS showed that EST-LBD was as effective as EST for the removal of large or difficult of CBDS in terms of stone clearance in the first ERCP session of 87.87 % vs. 84.15 % and overall clearance of 97.35 % vs. 96.35 % but EST-LBD was associated with fewer complications as well as reduced need for ML compared to EST. The efficacy of EST-ML versus EST-LBD as a therapy for relatively large CBDS, a mean stone size > 20 mm in currently not well defined. The investigators, herein, compared the efficacy and complications between EST followed by LBD or ML for the removal of CBDS > 15 mm with a mean stone size > 20 mm.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkla
      • Hatyai, Songkla, Thailand, 90110
        • NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: -Patients with age>/= 18 years with confirmed or suspected CBDS at our institute were enrolled in the study.

  • Informed consent was obtained in every patients prior to the procedure
  • Patients were randomized to LBD or ML if they had CBD stone >/= 15 mm in shortest dimension or stone' size was disproportionate to the lower bile duct segment with a ratio of largest stone dimension/lower bile duct segment diameter > 50 % identified by a cholangiogram at ERCP.

Exclusion Criteria:-pregnant woman

  • uncorrectable coagulopathy (INR >1.5 ), thrombocytopenia( platelet count < 50,000)
  • concomitant intrahepatic duct stones
  • ongoing acute pancreatitis or acute cholecystitis
  • surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction)
  • concomitant pancreatic or biliary malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Large balloon dilatation
Patients underwent clearance of common bile duct stones using a papillary large balloon dilatation.
Procedure: Large balloon dilatation
After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 12, 15, 18 or 20 mm CRE-balloon was passed over guide wire and position across the papilla. The balloon was gradually inflated to the largest size of the bile duct stone and/or the bile duct diameter. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.
Active Comparator: Mechanical lithotripsy
Patients underwent clearance of common bile duct stones using a mechanical lithotripsy.
Procedure: Mechanical lithotripsy
After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 3x6 cm Trapezoid Rx retrieval stone basket was used to capture the stone and crushing of stones was done when simple stone extraction failed to remove the stone. The stone fragments were then retrieved with a basket and/ or a retrieval balloon. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete stone clearance rate in the index ERCP
Time Frame: 24 hours
The number of patients who was achieved complete stone clearance in the index ERCP
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: 24 hours
The procedure time was the time between insertion of the index device namely, a balloon or ML, and occlusion of cholangiogram
24 hours
Complete stone clearance rate in the rescue therapy
Time Frame: 24 hours
The number of patients who was achieved complete stone clearance in the rescue therapy
24 hours
Complication rate
Time Frame: 30 days
The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prince of Songkla University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bancha Ovartlarnporn, MD., NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 53-170-14-3-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The individual data of patients participating in the study are not available for public sharing since we did not obtain the consent to share the data of patient

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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