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

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ClinicalTrials.gov Identifier: NCT02592811
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
KARSENTI, Société Française d'Endoscopie Digestive

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.


Condition or disease Intervention/treatment Phase
Choledocholithiasis Large Common Bile Duct Stone Procedure: ERCP Procedure: Endoscopic Sphincterotomy Device: Large Balloon Dilatation of Oddi Sphincter Procedure: Stone extraction Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Randomized Study
Study Start Date : July 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Endoscopy

Arm Intervention/treatment
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 Name: Cholangiogram with deep cannulation of CBD

Procedure: Endoscopic Sphincterotomy
Endoscopic large sphincterotomy
Other Name: 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 Name: 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 Name: Cholangiogram with deep cannulation of CBD

Procedure: Endoscopic Sphincterotomy
Endoscopic large sphincterotomy
Other Name: 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




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

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592811


Sponsors and Collaborators
Société Française d'Endoscopie Digestive
Investigators
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Principal Investigator: David KARSENTI, MD Société Française d'Endoscopie Digestive

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KARSENTI, MD, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier: NCT02592811     History of Changes
Other Study ID Numbers: SocieteFranceED
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Keywords provided by KARSENTI, Société Française d'Endoscopie Digestive:
Cholangiopancreatography
therapeutic strategy
Endoscopic Retrograde
Additional relevant MeSH terms:
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Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis