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NCT Number: NCT02666820

Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones

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.

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Key information

Conditions

Common Bile Duct Stones

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Large balloon dilatation

Procedure

After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 12, 15, 18 or 20 mm CRE-balloon was passed over guide wire and position across the papilla. The balloon was gradually inflated to the largest size of the bile duct stone and/or the bile duct diameter. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.

Mechanical lithotripsy

Procedure

After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 3x6 cm Trapezoid Rx retrieval stone basket was used to capture the stone and crushing of stones was done when simple stone extraction failed to remove the stone. The stone fragments were then retrieved with a basket and/ or a retrieval balloon. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.

Primary outcomes

  1. Complete stone clearance rate in the index ERCP

    Time frame: 24 hours

    The number of patients who was achieved complete stone clearance in the index ERCP

Secondary outcomes

  1. Procedure time

    Time frame: 24 hours

    The procedure time was the time between insertion of the index device namely, a balloon or ML, and occlusion of cholangiogram

  2. Complete stone clearance rate in the rescue therapy

    Time frame: 24 hours

    The number of patients who was achieved complete stone clearance in the rescue therapy

  3. Complication rate

    Time frame: 30 days

    The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications.

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

Endoscopic Papillary Large Balloon Dilatation Versus Sphincterotomy +/- Mechanical Lithotripsy for Removal of Bile Duct Stones With a Mean Stone > 20 mm : A Randomized Controlled Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jan 28, 2016
Registry last updated
Jan 29, 2016

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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