Post-ERCP PancreatitisNCT01771419
Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct
A study testing Loop-tip wire (Cook Medical) for the cannulation of the CBD and Cannulotome CT-25mm Cook Medical in people with Post-ERCP Pancreatitis, run by Hospital San Paolo at 1 site in Italy.
Trial summary
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- Loop-tip wire (Cook Medical) for the cannulation of the CBD and Cannulotome CT-25mm Cook Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- high-risk patients for post-ERCP pancreatitis
Who cannot join
- age < 18 years
- allargy to the contrast medium
- previous biliary or gastric surgery
- neoplastic patients
- previous biliary or pancreatic sphincterotomy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Paolo Hospital
Milan, Italy, 20142
Benedetto Mangiavillano, MD, 0039 02 8184 ext. 4273, b_mangiavillano@hotmail.com
About this study
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- Loop-tip wire (Cook Medical) for the cannulation of the CBD, Cannulotome CT-25mm Cook Medical
- Keywords
- loop-tip, ERCP, cannulation of CBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop-tip wire (Cook Medical) for the cannulation of the CBDDevice
Cannulotome CT-25mm Cook MedicalDevice
| Study group | Role | What they receive |
|---|---|---|
| loop-tip arm | Experimental | The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.) Receives: Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD |
| Control arm | Active comparator | The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique) Receives: Device: Cannulotome CT-25mm Cook Medical |
What is being measured
The primary outcome is the main question the study is designed to answer.
post ERCP pancreatitis rate
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measured: up to 4 weeks
Secondary outcomes (1)
Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startOct 2010
- Primary completionFeb 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP PancreatitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Paolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedetto Mangiavillano, Hospital San Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771419
- Sponsor's protocol ID
- H San Paolo
- Status last verified
- Jan 2013
- First submitted
- 15 Jan 2013
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Masci E, Mangiavillano B, Luigiano C, Bizzotto A, Limido E, Cantu P, Manes G, Viaggi P, Spinzi G, Radaelli F, Mariani A, Virgilio C, Alibrandi A, Testoni PA. Comparison between loop-tip guidewire-assisted and conventional endoscopic cannulation in high risk patients. Endosc Int Open. 2015 Oct;3(5):E464-70. doi: 10.1055/s-0034-1392879. Epub 2015 Sep 15.
PubMed 26528503
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct
- ClinicalTrials.gov ID
- NCT01771419
- Acronym / sponsor ID
- H San Paolo
- Conditions
- Post-ERCP Pancreatitis
- Keywords
- loop-tip, ERCP, cannulation of CBD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Hospital San PaoloUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 18 Jan 2013 (estimated)
- 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.
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| loop-tip arm | Experimental | Device: Loop-tip wire (Cook Medical) for the cannulation of the CBDThe cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.) |
| Control arm | Active comparator | Device: Cannulotome CT-25mm Cook MedicalThe cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high-risk patients for post-ERCP pancreatitis
Key exclusion criteria (5 listed)
- age < 18 years
- allargy to the contrast medium
- previous biliary or gastric surgery
- neoplastic patients
- previous biliary or pancreatic sphincterotomy
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 |
|---|---|---|
| Loop-tip wire (Cook Medical) for the cannulation of the CBD | Device | loop-tip arm |
| Cannulotome CT-25mm Cook Medical | Device | Control arm |
Primary outcome
post ERCP pancreatitis rate
Time frame: up to 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
1 secondary outcome
Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Derived from this study: PubMed 26528503Masci E, Mangiavillano B, Luigiano C, Bizzotto A, Limido E, Cantu P, Manes G, Viaggi P, Spinzi G, Radaelli F, Mariani A, Virgilio C, Alibrandi A, Testoni PA. Comparison between loop-tip guidewire-assisted and conventional endoscopic cannulation in high risk patients. Endosc Int Open. 2015 Oct;3(5):E464-70. doi: 10.1055/s-0034-1392879. Epub 2015 Sep 15.
Related trials for Post-ERCP Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
RecruitingPhase 3
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
Not yet recruiting
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
Pancreatitis
Not yet recruiting
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
Recruiting
Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Pancreatitis, Acute
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loop-tip wire (Cook Medical) for the cannulation of the CBD and Cannulotome CT-25mm Cook Medical in people with Post-ERCP Pancreatitis, run by Hospital San Paolo at 1 site in Italy.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jan 2013. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post ERCP pancreatitis rate (time frame: up to 4 weeks). 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 NCT01771419, 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 18 Jan 2013.