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NCT Number: NCT05061680

Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)

ESGE guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla.

The investigators have good results in stone removal with much quicker dilatations when the cholangiogram is followed and the dilation is finished as soon as the disappearance of the waist of the papilla is seen. This Scandinavian multicenter prospective study is especially interested in stone clearance rate and short and long-term adverse events such as pancreatitis, cholangitis, bleeding, perforations, residual biliary stones, and newly developing biliary stones.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this study

This study is planned as a multicenter Scandinavian prospective study including all the patients >18 years with >10mm diameter common bile duct stones visible in cholangiogram. Before ERCP all patient will be informed about this trial, and if they agree to participate this study, they need to give a written informed consent. The endoscopists will decide whether the first step will be large EST and stone extraction or small EST and dilatation. If simple EST does not success, the dilatation will remain as a rescue method. The diameter of dilatation balloon cannot exceed the diameter of common bile duct above the papilla. Cholangiogram is followed when papilla is dilated and the dilatation will be ended when the waist of the papilla disappears. The duration of the dilatation measured, but it does not define the ending of dilatation. All adverse events will be recorded one month and a year after the procedure.

Classification of the patients:

  • EST and stone extraction
  • EPLBD when EST and stone extraction did not succeed
  • Short EST and EPLBD

The investigators will collect the information of adverse events such as bleeding, pancreatitis, cholangitis with patient questionnaire as well as from the patient records one month and a year after the procedure

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years
  • Common bile duct stone >10mm diameter

Exclusion criteria

  • Altered anatomy after surgery (B II, Roux-en-Y reconstruction)
  • Common bile duct cysts
  • Acute pancreatitis
  • Distal common bile duct stricture or tumor
  • Coagulation disorders
  • Ongoing coagulation medication
  • Pregnancy
  • Inability to give an informed consent

Treatment and study plan

endoscopic short duration papillary large balloon dilation

Device

During the large balloon papillary dilation investigators follow the cholangiogram and stop the dilatation as soon as the disappearance of the waist of the papilla is noticed.

Primary outcomes

  1. Rate of bleeding

    Time frame: 30 days

    need for additional intervention or need for blood transfusion and hemoglobin drop more than 2 gm/dL

  2. Rate of pancreatitis

    Time frame: 30 days

    Plasma amylase rises >3 times the upper limit and newly developed stomach ace more than 24h

  3. Rate of cholangitis

    Time frame: 30 days

    Fever >38

Study contacts

Contact information is provided by the study sponsor or research team.

Leena Kylänpää, MD, PhD

CONTACT

[email protected]

+35894711

Mia Rainio, MD, PhD

CONTACT

[email protected]

+358505833060

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Endoscopic Papillary Short Duration Large Balloon Dilatation for Removal of Large Bile Duct Stones: a Prospective Multicenter Study of Short and Long-term Adverse Events

Acronym: SHODBADI

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Sep 29, 2021
Registry last updated
Mar 1, 2023

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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