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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 Randomize

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.


Detailed Summary:
Sponsor: Société Française d'Endoscopie Digestive

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Length of procedure [ Time Frame: Day one ]
    For each patient, time was noted at the beginning and at the end of ERCP
  • 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
  • comparison of the frequency of mechanical lithotripsy of both groups [ Time Frame: Day one ]


    Original Secondary Outcome: Same as current

    Information By: Société Française d'Endoscopie Digestive

    Dates:
    Date Received: October 5, 2015
    Date Started: July 2010
    Date Completion:
    Last Updated: October 28, 2015
    Last Verified: October 2015