Comparison of Endoscopic Sphincterotomy Plus Large-balloon Dilatation and Conventional Treatment for Large CBD Stones

October 28, 2015 updated by: KARSENTI, Société Française d'Endoscopie Digestive

Endoscopic Sphincterotomy Plus Large-Balloon Dilatation (ESLBD) Versus Conventional Endoscopic Treatment for Removal of Large Common Bile Duct Stones : A Prospective Comparative Multi Center Randomized Study

Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones. Because of inconstant success, high cost, and length of procedure, an alternative method was proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (ESLBD). If the safety of ESLBD is accepted in all recent published studies, it remains controversial wether ESLBD is superior to conventional endoscopic treatment associating ES± ML for CBD stones. Procedure treatment and place of ESLBD in CBD stones therapeutic strategy is unclear.

The purpose of this prospective comparative multi center randomized study is to evaluate the superiority or not of ESLBD on conventional treatment (ES±ML) for the treatment of large bile duct stone (≥13mm) after standard ES, and to propose a new CBD stones therapeutic strategy.

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.

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.
150

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.
  • Phase 3

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:

  • Patient with CBD stones with a smaller diameter ≥ 13mm on cholangiogram

Exclusion Criteria:

  • Active or history of acute pancreatitis
  • Presence of intrahepatic stones
  • History of Billroth II or roux-en-Y reconstruction
  • Coagulation disorder (partial thromboplastin time > 42 seconds, prothrombin time (Quick value) < 50% and platelet count of <50 000/mm3)
  • Current anticoagulation or clopidogrel treatment
  • Pregnancy
  • Inability to give informed consent

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: ESLBD

Endoscopic Sphincterotomy plus Large Balloon Dilatation +/- lithotripsy

  1. ERCP with deep cancellation of BDS
  2. Endoscopic large sphincterotomy
  3. Large Balloon Dilatation of Oddi Sphincter: with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)
  4. Stone extraction with dormia basket or extraction balloon
  5. Mechanical Lithotripsy if needed
Procedure: ERCP
Common bile duct cannulation with a cannulation catheter
Other Names:
  • Cholangiogram with deep cannulation of CBD
Procedure: Endoscopic Sphincterotomy
Endoscopic large sphincterotomy
Other Names:
  • ES
Device: Large Balloon Dilatation of Oddi Sphincter
Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)
Other Names:
  • LBD, LBDS
Procedure: Stone extraction
After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed
Active Comparator: CONV

Conventional treatment associating Endoscopic Sphincterotomy +/- Mechanical Lithotripsy (ES+/-LM)

  1. ERCP with deep cancellation of BDS
  2. Endoscopic large sphincterotomy
  3. Stone extraction with dormia basket or extraction balloon
  4. Mechanical Lithotripsy if needed
Procedure: ERCP
Common bile duct cannulation with a cannulation catheter
Other Names:
  • Cholangiogram with deep cannulation of CBD
Procedure: Endoscopic Sphincterotomy
Endoscopic large sphincterotomy
Other Names:
  • ES
Procedure: Stone extraction
After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed

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
Time Frame
Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)
Time Frame: 1 month
1 month

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
Number of patients with mild or severe BLEEDING (Morbidity) after ERCP
Time Frame: 1 month

Immediate complications were noted :

  • bleeding : mild if blood transfusion not necessary, and severe if blood transfusion necessary
  • Clinical data (pain, fever, vomiting...) are noted during first month
  • Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure
  • In case of bleeding suspected, a new ERCP was done
  • Number of patients with bleeding and with any complication in both groups were noted and compared
1 month
Number of patients with mild or severe ACUTE PANCREATITIS (Morbidity) after ERCP
Time Frame: 1 month

Immediate complications were noted :

  • Acute pancreatitis : defined by the association of abdominal pain and lipase blood test > 3 N
  • Severity of acute pancreatitis was evaluated on CT index, and on evolution data
  • Clinical data (pain, fever, vomiting...) are noted during first month
  • Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure
  • Abdominal CT was performed in case of suspected acute pancreatitis
  • Number of patients with Acute Pancreatitis and any complication in both groups were noted and compared
1 month
Number of patients with PERFORATION (Morbidity of ERCP)
Time Frame: 1 day
  • Suspected on clinical data (pain, fever, vomiting...) and blood tests (Blood count, C reactive protein) noted during first day after ERCP:
  • confirmed on CT
  • Number of patients with perforation in both groups were noted and compared, and global morbidity in both groups were noted and compared
1 day
Number of patients with post ERCP INFECTION as angiocholitis, cholecystitis or urine infection, septicemia (Morbidity of ERCP)
Time Frame: 1 month
  • Suspected on clinical data (pain, fever, vomiting...), blood tests (Blood count, C reactive protein, blood and urine cultures), noted during first day after ERCP, during 30th day and more if necessary in the meantime
  • Abdominal US and CT were performed if necessary
  • Number of patients with infection in both groups were noted and compared, and global morbidity in both groups were noted and compared
1 month
GLOBAL MORBIDITY of ERCP (number of patients with bleeding and/or acute pancreatistis and/or perforation and/or infection)
Time Frame: 1 month
- Number of patients with any complication as bleeding, acute pancreatitis, perforation, infection (as angiocholitis, cholecystitis, urine infection or septicemia) happened in both groups during the first month after the procedure were noted and compared
1 month
MORTALITY of ERCP
Time Frame: 1 month
- Number of death happened in both groups during the first month after the procedure were noted and compared
1 month
Number of patients with recurrence of BDS
Time Frame: 1 month
  • Clinical data (pain, fever, vomiting...) are noted during first month
  • Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure
  • In case of recurrence BDS suspected, abdominal US and/or CT and/or MRI and/or EUS (Endoscopic Ultrasonography) were done, and if BDS was confirmed, a new ERCP was done
  • Number of patients with recurrence of BDS in both groups in the first month after the procedure were noted and compared
1 month
Length of procedure
Time Frame: Day one
For each patient, time was noted at the beginning and at the end of ERCP
Day one
Cost of procedure
Time Frame: Day one
All the instrument used during ERCP (endoscopic retrograde cholangiopancreatography) for each patient were noted, and at the end of procedure cost of all instruments were recorded
Day one
comparison of the frequency of mechanical lithotripsy of both groups
Time Frame: Day one
In both groups mechanical lithotripsy can be performed in case of impossibility of stone extraction. The rate of lithotripsy performed in both groups were compared
Day one

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.
Société Française d'Endoscopie Digestive

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.
  • Principal Investigator: David KARSENTI, MD, Société Française d'Endoscopie Digestive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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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.
July 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.
March 1, 2015

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.
March 1, 2015

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).
October 5, 2015

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.
October 28, 2015

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.
October 30, 2015

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.
October 30, 2015

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.
October 28, 2015

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.
October 1, 2015

More Information

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Other Study ID Numbers

Other Study ID Numbers

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  • SocieteFranceED

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