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Completed

NCT Number: NCT02330601

Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct

The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up to 60% of patients had stone recurrence within two years after stone retrieval by ERCP. Although EPLBD is useful for for extraction of large CBDS with less operation time and mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in patients with recurrent CBDS.Although Harada et al found that EPLBD might reduce the short-term recurrence of CBD stones in patients with previous ES. It is a retrospective study with a small sample size (n=94).

Here a prospective, randomized controlled study including two tertiary centers was designed. The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in patients with recurrent CBDS.

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Key information

Conditions

Endoscopic Papillary Large Balloon Dilation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital Of Xi'an Jiaotong University, Xi'an, Shaanxi, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-80
  • Patients with recurrent CBDS after ERCP

Exclusion criteria

  • Benign or malignant CBD stricture
  • Recurrent stone within 3 months after ERCP
  • Previous endoscopic papillary large balloon dilation (EPLBD)
  • Prior surgery of Bismuth II and Roux-en-Y
  • Septic shock
  • Coagulopathy (INR>1.3), platelet<50000 or using anti-coagulation drugs
  • With expected life span less than 24 months
  • Pregnant women
  • Refusal or unable to give written informed consent

Treatment and study plan

endoscopic papillary large balloon dilation

Procedure

For the patients in EPLBD group, a CRE balloon (diameter 10, 11, 12, 13.5, 15 mm; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast. When the waist disappeared, the balloon was kept inflated for 120s. The stones were then retrieved by a basket or a retrieval balloon.Mechanical lithotripsy was used if necessary

Other names: EPLBD

Primary outcomes

  1. Recurrent rate of CBDS within two years after ERCP

    Time frame: up to 2 years

    Within the two years after ERCP, CBDS was found again by CT, MRCP, ERCP or biliary surgery

Secondary outcomes

  1. recurrent time

    Time frame: up to 2 years

  2. success rate of stone extraction

    Time frame: up to 2 years

  3. success rate of stone extraction in the initial attempt

    Time frame: up to 2 years

  4. performance time of ERCP

    Time frame: up to 2 years

  5. rate of mechanical lithotripsy

    Time frame: up to 2 years

  6. post-ERCP complication

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2015
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.