Bile Duct DiseasesNCT05600270
Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation
A study testing Angled guidewire and Straight guidewire in people with Bile Duct Diseases, run by Neev Mehta at 1 site in United States.
Trial summary
The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bile Duct Diseases
- What is being tested?
- Angled guidewire and Straight guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2022to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing ERCP for cholangiography, bile or tissue sampling from the gallbladder or bile duct
- patients undergoing ERCP for treatment of biliary diseases (removal of common bile duct stones, biliary stent placement)
Who cannot join
- Patients who are less than 18 years old
- Pregnant patients
- Patients who have undergone previous bile duct cannulation or sphincterotomy
- Patients who have undergone prior endoscopic balloon dilation or needle-knife fistulotomy
- Patients who have undergone gastric surgery (Billroth gastrectomy II, Roux-en-Y gastric bypass)
- Patients with acute pancreatitis
- Patients who refuse endoscopic intervention
- Patients with ampullary tumor, duodenal stenosis, or pre-operatively proven pancreaticobiliary malunion
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
About this study
Official title: Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial
The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.
Read the detailed description
Wire-guided cannulation of the common bile duct is a standard technique utilized during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to ensure safe and effective access to the common bile duct via the ampulla of Vater. Due to the anatomy of the ampulla, and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. The investigators aim to assess the technical and clinical outcomes between an angled-tip guidewire (GW) compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. The investigators hypothesize that an angled-tip GW is associated with increased rate of successful cannulation, decreased procedure time and decreased rate of post-ERCP pancreatitis in wire-guided biliary cannulation during ERCP.
- Conditions
- Bile Duct Diseases
- Being tested
- Angled guidewire, Straight guidewire
- Keywords
- ERCP
- Medical subject headings
- Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angled guidewireDevice
Cannulation of the common bile duct using an angled-tip guidewire during ERCP
Straight guidewireDevice
Cannulation of the common bile duct using an straight-tip guidewire during ERCP
| Study group | Role | What they receive |
|---|---|---|
| Angled wire | Active comparator | Angled guidewire intervention arm Receives: Device: Angled guidewire |
| Straight wire | Active comparator | Straight guidewire intervention arm Receives: Device: Straight guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannulation
Rate of successful cannulation of common bile duct
Measured: Day of Procedure
Secondary outcomes (2)
Post ERCP Pancreatitis
Number of participants who develop post ERCP pancreatitis
Measured: Procedure day and up to day 5 post procedure
Duration
Total duration of procedure
Measured: Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start22 Oct 2022
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Duct DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Controlled, Single-Blinded Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neev Mehta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neev Mehta, Lahey Clinic
- Investigators
- Ann Marie Joyce, MD, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600270
- Sponsor's protocol ID
- 20223146
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2022
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Vihervaara H, Gronroos JM, Koivisto M, Gullichsen R, Salminen P. Angled- or straight-tipped hydrophilic guidewire in biliary cannulation: a prospective, randomized, controlled trial. Surg Endosc. 2013 Apr;27(4):1281-6. doi: 10.1007/s00464-012-2596-6. Epub 2012 Dec 19.
PubMed 23250671
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT05600270
- Acronym / sponsor ID
- 20223146
- Conditions
- Bile Duct Diseases
- Keywords
- ERCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Neev MehtaUniversity, hospital or other
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.
Detailed description
Wire-guided cannulation of the common bile duct is a standard technique utilized during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to ensure safe and effective access to the common bile duct via the ampulla of Vater. Due to the anatomy of the ampulla, and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. The investigators aim to assess the technical and clinical outcomes between an angled-tip guidewire (GW) compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. The investigators hypothesize that an angled-tip GW is associated with increased rate of successful cannulation, decreased procedure time and decreased rate of post-ERCP pancreatitis in wire-guided biliary cannulation during ERCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, Controlled, Single-Blinded Trial
| Arm | Type | Receives |
|---|---|---|
| Angled wire | Active comparator | Device: Angled guidewireAngled guidewire intervention arm |
| Straight wire | Active comparator | Device: Straight guidewireStraight guidewire intervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing ERCP for cholangiography, bile or tissue sampling from the gallbladder or bile duct
- patients undergoing ERCP for treatment of biliary diseases (removal of common bile duct stones, biliary stent placement)
Key exclusion criteria (8 listed)
- Patients who are less than 18 years old
- Pregnant patients
- Patients who have undergone previous bile duct cannulation or sphincterotomy
- Patients who have undergone prior endoscopic balloon dilation or needle-knife fistulotomy
- Patients who have undergone gastric surgery (Billroth gastrectomy II, Roux-en-Y gastric bypass)
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 |
|---|---|---|
| Angled guidewireCannulation of the common bile duct using an angled-tip guidewire during ERCP | Device | Angled wire |
| Straight guidewireCannulation of the common bile duct using an straight-tip guidewire during ERCP | Device | Straight wire |
Primary outcome
Cannulation
Time frame: Day of Procedure
Rate of successful cannulation of common bile duct
2 secondary outcomes
Post ERCP Pancreatitis
Time frame: Procedure day and up to day 5 post procedure
Duration
Time frame: Day of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23250671Vihervaara H, Gronroos JM, Koivisto M, Gullichsen R, Salminen P. Angled- or straight-tipped hydrophilic guidewire in biliary cannulation: a prospective, randomized, controlled trial. Surg Endosc. 2013 Apr;27(4):1281-6. doi: 10.1007/s00464-012-2596-6. Epub 2012 Dec 19.
- 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. This study is not recruiting at the moment.
Ann Marie Joyce, MD principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angled guidewire and Straight guidewire in people with Bile Duct Diseases, run by Neev Mehta at 1 site in United States.
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: finished, as of the sponsor's last update on 31 Oct 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannulation (time frame: Day of Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05600270, which also lists 1 linked publication.
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 31 Oct 2024.