CholedocholithiasisPAPRELAXNCT07814976
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
A study testing Hyoscine Butylbromide in people with Choledocholithiasis and Common Bile Duct Stones, run by Riga East Clinical University Hospital at 1 site in Latvia.
Trial summary
The purpose of the PAPRELAX study is to evaluate the intraoperative effect of intravenous hyoscine butylbromide during laparoscopic transcystic balloon dilation of the papilla of Vater in adult patients undergoing surgical treatment for choledocholithiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis, Common Bile Duct Stones
- What is being tested?
- Hyoscine Butylbromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLatvia
- Study dates
- 4 Jan 2026to 1 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Written informed consent for participation in the study.
- Confirmed choledocholithiasis.
- Common bile duct stone diameter of 15 mm or less.
- General medical condition permitting laparoscopic cholecystectomy.
Who cannot join
- Age younger than 18 years.
- Refusal to provide written informed consent.
- Spontaneous antegrade evacuation of common bile duct stones during conservative treatment.
- Previous cholecystectomy.
- Common bile duct stone diameter greater than 15 mm.
- General medical condition not permitting laparoscopic cholecystectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anastasija Klodčika, Dr. contact
Latvia1 site, 1 recruiting
- Recruiting
Riga East University Hospital
Riga
Igors Ivanovs, Asoc.Prof., +371 29184455, dr.igors.ivanovs@gmail.com
Dmitrijs Aleksandrovs, Dr.
About this study
Official title: Intraoperative Hyoscine Butylbromide During Laparoscopic Transcystic Papillary Balloon Dilation for Choledocholithiasis: A Prospective Interventional Study With Historical Controls
The purpose of the PAPRELAX study is to evaluate the intraoperative effect of intravenous hyoscine butylbromide during laparoscopic transcystic balloon dilation of the papilla of Vater in adult patients undergoing surgical treatment for choledocholithiasis.
The study will evaluate whether administration of hyoscine butylbromide influences the duration of transcystic papillary balloon dilation and the balloon inflation pressure required for papillary dilation.
Eligible participants enrolled prospectively will receive 20 mg of intravenous hyoscine butylbromide during laparoscopic transcystic papillary balloon dilation. Procedural characteristics and postoperative outcomes will be compared with those of a historical control cohort of patients who previously underwent the same procedure without hyoscine butylbromide.
Read the detailed description
Choledocholithiasis is commonly treated using endoscopic or surgical bile duct clearance techniques. Laparoscopic transcystic papillary balloon dilation enables antegrade clearance of common bile duct stones during laparoscopic surgery.
Smooth muscle contraction and papillary spasm may complicate transcystic manipulation, balloon passage, and dilation of the papilla of Vater. Hyoscine butylbromide is a peripheral antimuscarinic agent that reduces gastrointestinal smooth muscle tone and is routinely used in several gastrointestinal endoscopic and radiological procedures.
The PAPRELAX study is a single-center prospective interventional study with a retrospective historical control cohort.
In the prospective cohort, eligible adult patients with confirmed choledocholithiasis undergoing laparoscopic transcystic papillary balloon dilation will receive hyoscine butylbromide 20 mg intravenously during the procedure.
Procedural data will include the duration of transcystic papillary balloon dilation and the balloon inflation pressure required to perform dilation of the papilla of Vater. Postoperative complications will also be recorded.
The outcomes of prospectively enrolled patients receiving hyoscine butylbromide will be compared with a historical cohort of patients who previously underwent laparoscopic transcystic papillary balloon dilation without administration of hyoscine butylbromide.
The study is conducted at Riga East Clinical University Hospital "Gaiļezers", Riga, Latvia.
- Conditions
- Choledocholithiasis, Common Bile Duct Stones
- Being tested
- Hyoscine Butylbromide
- Keywords
- Choledocholithiasis, Common Bile Duct Stones, Hyoscine Butylbromide, Papilla of Vater, Papillary Balloon Dilation, Transcystic Approach, Laparoscopic Cholecystectomy
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine ButylbromideDrug
Also called Buscopan
Hyoscine butylbromide 20 mg will be administered intravenously during laparoscopic transcystic balloon dilation of the papilla of Vater.
The intervention is intended to reduce smooth muscle tone during transcystic papillary manipulation and balloon dilation.
Frequency: Single intraoperative administration
| Study group | Role | What they receive |
|---|---|---|
| Hyoscine Butylbromide | Experimental | Participants with confirmed choledocholithiasis undergoing laparoscopic transcystic balloon dilation of the papilla of Vater will receive hyoscine butylbromide 20 mg intravenously during the procedure. Procedural characteristics and postoperative outcomes will be prospectively recorded.
Outcomes will subsequently be compared with those of a retrospective historical control cohort that underwent the same procedure without administration of hyoscine butylbromide. Receives: Drug: Hyoscine Butylbromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balloon Inflation Pressure Required for Papillary Dilation
Balloon inflation pressure required to perform transcystic balloon dilation of the papilla of Vater during the index surgical procedure.
Measured: Intraoperative
Secondary outcomes (1)
Postoperative Complications
Number and proportion of participants experiencing postoperative complications following laparoscopic transcystic papillary balloon dilation with intraoperative administration of hyoscine butylbromide.
Measured: Within 30 days after the index surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start4 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm interventional study with comparison of procedural and postoperative outcomes with a retrospective historical control cohort of patients who underwent the same surgical procedure without hyoscine butylbromide.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riga East Clinical University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Latvia
- Responsible party
- Principal investigator, Igors Ivanovs, Riga East Clinical University Hospital
- Investigators
- Igors Ivanovs, Asoc.Prof., Study director, University of LatviaDmitrijs Aleksandrovs, Dr., Principal investigator, University of Latvia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814976
- Sponsor's protocol ID
- PAPRELAX-2026-01
- Acronym
- PAPRELAX
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data underlying the results reported in the publication may be made available upon reasonable scientific request and following approval by the study investigators and applicable institutional and data-protection authorities.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Hyoscine Butylbromide During Laparoscopic Transcystic Papillary Balloon Dilation for Choledocholithiasis: A Prospective Interventional Study With Historical Controls
- ClinicalTrials.gov ID
- NCT07814976
- Acronym / sponsor ID
- PAPRELAX / PAPRELAX-2026-01
- Conditions
- Choledocholithiasis, Common Bile Duct Stones
- Keywords
- Choledocholithiasis, Common Bile Duct Stones, Hyoscine Butylbromide, Papilla of Vater, Papillary Balloon Dilation, Transcystic Approach, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riga East Clinical University HospitalOther government
- Collaborators
- University of Latvia
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 11 Sep 2026 (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.
The purpose of the PAPRELAX study is to evaluate the intraoperative effect of intravenous hyoscine butylbromide during laparoscopic transcystic balloon dilation of the papilla of Vater in adult patients undergoing surgical treatment for choledocholithiasis.
The study will evaluate whether administration of hyoscine butylbromide influences the duration of transcystic papillary balloon dilation and the balloon inflation pressure required for papillary dilation.
Eligible participants enrolled prospectively will receive 20 mg of intravenous hyoscine butylbromide during laparoscopic transcystic papillary balloon dilation. Procedural characteristics and postoperative outcomes will be compared with those of a historical control cohort of patients who previously underwent the same procedure without hyoscine butylbromide.
Detailed description
Choledocholithiasis is commonly treated using endoscopic or surgical bile duct clearance techniques. Laparoscopic transcystic papillary balloon dilation enables antegrade clearance of common bile duct stones during laparoscopic surgery.
Smooth muscle contraction and papillary spasm may complicate transcystic manipulation, balloon passage, and dilation of the papilla of Vater. Hyoscine butylbromide is a peripheral antimuscarinic agent that reduces gastrointestinal smooth muscle tone and is routinely used in several gastrointestinal endoscopic and radiological procedures.
The PAPRELAX study is a single-center prospective interventional study with a retrospective historical control cohort.
In the prospective cohort, eligible adult patients with confirmed choledocholithiasis undergoing laparoscopic transcystic papillary balloon dilation will receive hyoscine butylbromide 20 mg intravenously during the procedure.
Procedural data will include the duration of transcystic papillary balloon dilation and the balloon inflation pressure required to perform dilation of the papilla of Vater. Postoperative complications will also be recorded.
The outcomes of prospectively enrolled patients receiving hyoscine butylbromide will be compared with a historical cohort of patients who previously underwent laparoscopic transcystic papillary balloon dilation without administration of hyoscine butylbromide.
The study is conducted at Riga East Clinical University Hospital "Gaiļezers", Riga, Latvia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm interventional study with comparison of procedural and postoperative outcomes with a retrospective historical control cohort of patients who underwent the same surgical procedure without hyoscine butylbromide.
| Arm | Type | Receives |
|---|---|---|
| Hyoscine Butylbromide | Experimental | Drug: Hyoscine ButylbromideParticipants with confirmed choledocholithiasis undergoing laparoscopic transcystic balloon dilation of the papilla of Vater will receive hyoscine butylbromide 20 mg intravenously during the procedure. Procedural characteristics and postoperative outcomes will be prospectively recorded. Outcomes will subsequently be compared with those of a retrospective historical control cohort that underwent the same procedure without administration of hyoscine butylbromide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Written informed consent for participation in the study.
- Confirmed choledocholithiasis.
- Common bile duct stone diameter of 15 mm or less.
- General medical condition permitting laparoscopic cholecystectomy.
Key exclusion criteria (6 listed)
- Age younger than 18 years.
- Refusal to provide written informed consent.
- Spontaneous antegrade evacuation of common bile duct stones during conservative treatment.
- Previous cholecystectomy.
- Common bile duct stone diameter greater than 15 mm.
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 |
|---|---|---|
| Hyoscine ButylbromideAlso: BuscopanHyoscine butylbromide 20 mg will be administered intravenously during laparoscopic transcystic balloon dilation of the papilla of Vater. The intervention is intended to reduce smooth muscle tone during transcystic papillary manipulation and balloon dilation. Frequency: Single intraoperative administration | Drug | Hyoscine Butylbromide |
Primary outcome
Balloon Inflation Pressure Required for Papillary Dilation
Time frame: Intraoperative
Balloon inflation pressure required to perform transcystic balloon dilation of the papilla of Vater during the index surgical procedure.
1 secondary outcome
Postoperative Complications
Time frame: Within 30 days after the index surgical procedure.
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 11 Sep 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data underlying the results reported in the publication may be made available upon reasonable scientific request and following approval by the study investigators and applicable institutional and data-protection authorities.
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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.
Anastasija Klodčika, Dr. contact
Igors Ivanovs, Asoc.Prof. study director
University of Latvia
Dmitrijs Aleksandrovs, Dr. principal investigator
University of Latvia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyoscine Butylbromide in people with Choledocholithiasis and Common Bile Duct Stones, run by Riga East Clinical University Hospital at 1 site in Latvia.
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 5 inclusion and 6 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. 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 Dmitrijs Aleksandrovs, Dr. (+37127013234, dmitrijs.aleksandrovs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balloon Inflation Pressure Required for Papillary Dilation (time frame: Intraoperative). 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 11 Sep 2026.