Pancreatitis, AcuteSHODBADINCT05061680
Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)
A study testing endoscopic short duration papillary large balloon dilation in people with Pancreatitis, Acute and Bleeding, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Pancreatitis, Acute, Bleeding, Cholangitis
- What is being tested?
- endoscopic short duration papillary large balloon dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesFinland
- Study dates
- 5 Apr 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Common bile duct stone >10mm diameter
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Mia Rainio, MD, PhD, +358505833060, mia.rainio@hus.fi
Leena Kylänpää, Md PhD, +35894711, leena.kylanpaa@hus.fi
- Recruiting
Turku University Hospital
Turku
Juha Grönroos, Professor, +358 2 3130000, juha.gronroos@tyks.fi
About this study
Official 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
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.
Read the detailed description
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
- Conditions
- Pancreatitis, Acute, Bleeding, Cholangitis
- Being tested
- endoscopic short duration papillary large balloon dilation
- Medical subject headings
- Pancreatitis, Hemorrhage, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic short duration papillary large balloon dilationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| short sphincterotomy +Short duration papillary large balloon dilation | Active comparator | Patients with short sphincterotomy Receives: Device: endoscopic short duration papillary large balloon dilation |
| full sphincterotomy + short duration papillary balloon dilation | Active comparator | Patients with full lenght sphincterotomy Receives: Device: endoscopic short duration papillary large balloon dilation |
| previous sphincterotomy + short duration papillary balloon dilation | Active comparator | Patients with previous sphincterotomy Receives: Device: endoscopic short duration papillary large balloon dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bleeding
need for additional intervention or need for blood transfusion and hemoglobin drop more than 2 gm/dL
Measured: 30 days
Rate of pancreatitis
Plasma amylase rises >3 times the upper limit and newly developed stomach ace more than 24h
Measured: 30 days
Rate of cholangitis
Fever >38
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start5 Apr 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mia Rainio, Helsinki University Central Hospital
- Investigators
- Mia Rainio, Md, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061680
- Sponsor's protocol ID
- Largeballoon dilation
- Acronym
- SHODBADI
- Status last verified
- Feb 2023
- First submitted
- 20 Sep 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05061680
- Acronym / sponsor ID
- SHODBADI / Largeballoon dilation
- Conditions
- Pancreatitis, Acute, Bleeding, Cholangitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| short sphincterotomy +Short duration papillary large balloon dilation | Active comparator | Device: endoscopic short duration papillary large balloon dilationPatients with short sphincterotomy |
| full sphincterotomy + short duration papillary balloon dilation | Active comparator | Device: endoscopic short duration papillary large balloon dilationPatients with full lenght sphincterotomy |
| previous sphincterotomy + short duration papillary balloon dilation | Active comparator | Device: endoscopic short duration papillary large balloon dilationPatients with previous sphincterotomy |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Common bile duct stone >10mm diameter
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic short duration papillary large balloon dilationDuring 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. | Device | full sphincterotomy + short duration papillary balloon dilation, previous sphincterotomy + short duration papillary balloon dilation, short sphincterotomy +Short duration papillary large balloon dilation |
Primary outcome
Rate of bleeding
Time frame: 30 days
need for additional intervention or need for blood transfusion and hemoglobin drop more than 2 gm/dL
Rate of pancreatitis
Time frame: 30 days
Plasma amylase rises >3 times the upper limit and newly developed stomach ace more than 24h
Rate of cholangitis
Time frame: 30 days
Fever >38
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mia Rainio, Md, PhD study director
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic short duration papillary large balloon dilation in people with Pancreatitis, Acute and Bleeding, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mia Rainio, MD, PhD (+358505833060, mia.rainio@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bleeding (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.