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NCT Number: NCT02592811

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ERCP

Procedure

Common bile duct cannulation with a cannulation catheter

Other names: Cholangiogram with deep cannulation of CBD

Endoscopic Sphincterotomy

Procedure

Endoscopic large sphincterotomy

Other names: ES

Large Balloon Dilatation of Oddi Sphincter

Device

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

Other names: LBD, LBDS

Stone extraction

Procedure

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

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Length of procedure

    Time frame: Day one

    For each patient, time was noted at the beginning and at the end of ERCP

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2015
Registry last updated
Oct 30, 2015

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.

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