NCT02592811

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

4.7 years

First QC Date

October 5, 2015

Last Update Submit

October 28, 2015

Conditions

CholedocholithiasisLarge Common Bile Duct Stone

Keywords

Cholangiopancreatographytherapeutic strategyEndoscopic Retrograde

Outcome Measures

Primary Outcomes (1)

  • Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)

    1 month

Secondary Outcomes (10)

  • Number of patients with mild or severe BLEEDING (Morbidity) after ERCP

    1 month

  • Number of patients with mild or severe ACUTE PANCREATITIS (Morbidity) after ERCP

    1 month

  • Number of patients with PERFORATION (Morbidity of ERCP)

    1 day

  • Number of patients with post ERCP INFECTION as angiocholitis, cholecystitis or urine infection, septicemia (Morbidity of ERCP)

    1 month

  • GLOBAL MORBIDITY of ERCP (number of patients with bleeding and/or acute pancreatistis and/or perforation and/or infection)

    1 month

  • +5 more secondary outcomes

Study Arms (2)

ESLBD

ACTIVE COMPARATOR

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: ERCPProcedure: Endoscopic SphincterotomyDevice: Large Balloon Dilatation of Oddi SphincterProcedure: Stone extraction

CONV

ACTIVE COMPARATOR

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: ERCPProcedure: Endoscopic SphincterotomyProcedure: Stone extraction

Interventions

ERCPPROCEDURE

Common bile duct cannulation with a cannulation catheter

Also known as: Cholangiogram with deep cannulation of CBD
CONVESLBD
Endoscopic SphincterotomyPROCEDURE

Endoscopic large sphincterotomy

Also known as: ES
CONVESLBD
Large Balloon Dilatation of Oddi SphincterDEVICE

Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)

Also known as: LBD, LBDS
ESLBD
Stone extractionPROCEDURE

After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed

CONVESLBD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Karsenti D, Coron E, Vanbiervliet G, Privat J, Kull E, Bichard P, Perrot B, Quentin V, Duriez A, Cholet F, Subtil C, Duchmann JC, Lefort C, Hudziak H, Koch S, Granval P, Lecleire S, Charachon A, Barange K, Cesbron EM, De Widerspach A, Le Baleur Y, Barthet M, Poincloux L. Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study. Endoscopy. 2017 Oct;49(10):968-976. doi: 10.1055/s-0043-114411. Epub 2017 Jul 28.

    PMID: 28753698DERIVED

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic RetrogradeSphincterotomy, Endoscopic

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresBiliary Tract Surgical ProceduresEndoscopy, GastrointestinalSphincterotomyMyotomy

Study Officials

  • David KARSENTI, MD

    Société Française d'Endoscopie Digestive

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 30, 2015

Study Start

July 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 30, 2015

Record last verified: 2015-10