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Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones

P

Prince of Songkla University

Status

Completed

Conditions

Common Bile Duct Stones

Treatments

Procedure: Large balloon dilatation
Procedure: Mechanical lithotripsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02666820
53-170-14-3-2

Details and patient eligibility

About

Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been increasingly accepted as alternative method for removal of large bile duct stones. However, there were limited studies comparing the efficacy of EST in combined with LBD to EST with mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of combined EST- LBD versus EST-ML in the removal of very large bile duct stones.

Full description

The large common bile duct stones (CBDS) remains a therapeutic challenge in ERCPs. Large CBDS are generally refractory to be removed by EST and stone extraction balloons and or baskets. Traditional rescue therapy was the technique of stone fragmentation using ML. The previous reports have shown that EST with ML was successful in the fragmentation of large stones yielding stone clearance rate from 68 t0 79 %. EST-LBD has been shown favorable outcome in the treatment of large bile duct stone. A meta-analysis comparing the effectiveness and complications between EST-LBD and EST in the management of CBDS showed that EST-LBD was as effective as EST for the removal of large or difficult of CBDS in terms of stone clearance in the first ERCP session of 87.87 % vs. 84.15 % and overall clearance of 97.35 % vs. 96.35 % but EST-LBD was associated with fewer complications as well as reduced need for ML compared to EST. The efficacy of EST-ML versus EST-LBD as a therapy for relatively large CBDS, a mean stone size > 20 mm in currently not well defined. The investigators, herein, compared the efficacy and complications between EST followed by LBD or ML for the removal of CBDS > 15 mm with a mean stone size > 20 mm.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: -Patients with age>/= 18 years with confirmed or suspected CBDS at our institute were enrolled in the study.

  • Informed consent was obtained in every patients prior to the procedure
  • Patients were randomized to LBD or ML if they had CBD stone >/= 15 mm in shortest dimension or stone' size was disproportionate to the lower bile duct segment with a ratio of largest stone dimension/lower bile duct segment diameter > 50 % identified by a cholangiogram at ERCP.

Exclusion Criteria:-pregnant woman

  • uncorrectable coagulopathy (INR >1.5 ), thrombocytopenia( platelet count < 50,000)
  • concomitant intrahepatic duct stones
  • ongoing acute pancreatitis or acute cholecystitis
  • surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction)
  • concomitant pancreatic or biliary malignancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

85 participants in 2 patient groups

Large balloon dilatation
Active Comparator group
Description:
Patients underwent clearance of common bile duct stones using a papillary large balloon dilatation.
Treatment:
Procedure: Large balloon dilatation
Mechanical lithotripsy
Active Comparator group
Description:
Patients underwent clearance of common bile duct stones using a mechanical lithotripsy.
Treatment:
Procedure: Mechanical lithotripsy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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