Difficult Biliary CannulationPRECABIDONCT06591364
Prevalence and Predictive Factors of Difficult Biliary Cannulation
An observational study of Difficult Biliary Cannulation, run by University of La Laguna.
Trial summary
The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Biliary Cannulation
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2024to 30 Oct 2025
- Phase
- Observational
- 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
Study population: All the consecutive patients with an indication of a endoscopic retrograde cholangiopancreatography meeting inclusion and exclusion criteria will be included
Who may be able to join
- Age >18 years
- Signed informed consent
- Patients indicated for ERCP
Who cannot join
- INR > 1.5
- Platelets < 50,000/mm³
- Patients with a prior endoscopic sphincterotomy
- Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
- Known pancreas divisum
- Indication due to pancreatic duct pathology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence and Predictive Factors of Difficult Biliary Cannulation: a Multicenter Study
The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well as the predictive factors for this event in a prospective, multicenter study. Consecutive patients undergoing ERCP will be included in the study
We will also assess:
Read more
Evaluate the failure of biliary cannulation in our setting. Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria.
Design an "a priori" predictive model for difficult cannulation and cannulation failure.
Cost study: record of materials used.
Read the detailed description
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the indication for the procedure, and technical variables.
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience. All patients, except in cases of allergy, will receive 1 suppository of indomethacin or diclofenac before the procedure. In cases of allergy, pre-procedure hydration with Ringer's lactate will be administered if there is no contraindication (consider the protocol proposed by the ESGE: 3 mL/kg/hour during ERCP, 20 mL/kg as a bolus after ERCP, and 3 mL/kg/hour for 8 hours post-ERCP). The use of a pancreatic stent should be considered when indicated.
After the procedure, patients will remain hospitalized for at least 24 hours in the hospital. The patient's medical record will be reviewed 7 days after the procedure to check for any adverse effects, and a follow-up phone call will be made to detect any adverse effects.
Initially, a pilot study will be conducted with 600 patients, assessing based on the results-that is, the percentage of patients with difficult cannulation and the number of independent variables associated in the multiple logistic regression-the need to include a larger number of patients. For each variable included in the multiple logistic regression analysis, 8 to 10 cases of patients with difficult cannulation would be required.
- Conditions
- Difficult Biliary Cannulation
- Keywords
- ERCP, Endoscopic retrograde cholangiopancreatography, Difficult biliary cannulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult biliary cannulation
(> 5 minutes duration until cannulation, > 5 cannulation attempts, > 1 passage of the guidewire into the main pancreatic duct
Measured: 1 year
Secondary outcomes (4)
Failure of biliary cannulation
Not possibility of biliary cannulation during the procedure
Measured: 1 year
Predictive factors for difficult cannulation and cannulation failure
Factors independently associated with difficult cannulation and cannulation failure
Measured: 1 year
Designing an "a priori" predictive model for difficult cannulation and cannulation failure
Considering the factors independently associated with difficult cannulation and cannulation failure
Measured: 1 year
To carry out a cost study
considering direct costs of the procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Difficult Biliary CannulationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Hernandez-Guerra, MD, University of La Laguna
- Investigators
- Antonio Z Gimeno García, MD, PhD, Principal investigator, University Hospital of the Canary Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591364
- Sponsor's protocol ID
- PRECABIDO
- Acronym
- PRECABIDO
- Status last verified
- Aug 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baron TH, Petersen BT, Mergener K, Chak A, Cohen J, Deal SE, Hoffinan B, Jacobson BC, Petrini JL, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for endoscopic retrograde cholangiopancreatography. Am J Gastroenterol. 2006 Apr;101(4):892-7. doi: 10.1111/j.1572-0241.2006.00675.x. No abstract available.
PubMed 16635233Caceres-Escobar D, Munoz-Velandia OM, Vargas-Rubio R. FACTORS ASSOCIATED WITH DIFFICULT BILIARY CANNULATION IN A TRAINING CENTER FOR ENDOSCOPIC INTERVENTION OF THE BILIARY TRACT. Arq Gastroenterol. 2022 Jan-Mar;59(1):29-34. doi: 10.1590/S0004-2803.202200001-06.
PubMed 35442332Dalal A, Gandhi C, Patil G, Kamat N, Vora S, Maydeo A. Safety and efficacy of different techniques in difficult biliary cannulation at endoscopic retrograde cholangiopancreatography. Hosp Pract (1995). 2022 Feb;50(1):61-67. doi: 10.1080/21548331.2022.2029451. Epub 2022 Jan 20.
PubMed 35025705Saito H, Kadono Y, Shono T, Kamikawa K, Urata A, Nasu J, Imamura H, Matsushita I, Kakuma T, Tada S. Factors Predicting Difficult Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography for Common Bile Duct Stones. Clin Endosc. 2022 Mar;55(2):263-269. doi: 10.5946/ce.2021.153. Epub 2021 Nov 12.
PubMed 34763384
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Predictive Factors of Difficult Biliary Cannulation: a Multicenter Study
- ClinicalTrials.gov ID
- NCT06591364
- Acronym / sponsor ID
- PRECABIDO / PRECABIDO
- Conditions
- Difficult Biliary Cannulation
- Keywords
- ERCP, Endoscopic retrograde cholangiopancreatography, Difficult biliary cannulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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 main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well as the predictive factors for this event in a prospective, multicenter study. Consecutive patients undergoing ERCP will be included in the study
We will also assess:
Evaluate the failure of biliary cannulation in our setting. Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria.
Design an "a priori" predictive model for difficult cannulation and cannulation failure.
Cost study: record of materials used.
Detailed description
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the indication for the procedure, and technical variables.
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience. All patients, except in cases of allergy, will receive 1 suppository of indomethacin or diclofenac before the procedure. In cases of allergy, pre-procedure hydration with Ringer's lactate will be administered if there is no contraindication (consider the protocol proposed by the ESGE: 3 mL/kg/hour during ERCP, 20 mL/kg as a bolus after ERCP, and 3 mL/kg/hour for 8 hours post-ERCP). The use of a pancreatic stent should be considered when indicated.
After the procedure, patients will remain hospitalized for at least 24 hours in the hospital. The patient's medical record will be reviewed 7 days after the procedure to check for any adverse effects, and a follow-up phone call will be made to detect any adverse effects.
Initially, a pilot study will be conducted with 600 patients, assessing based on the results-that is, the percentage of patients with difficult cannulation and the number of independent variables associated in the multiple logistic regression-the need to include a larger number of patients. For each variable included in the multiple logistic regression analysis, 8 to 10 cases of patients with difficult cannulation would be required.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the consecutive patients with an indication of a endoscopic retrograde cholangiopancreatography meeting inclusion and exclusion criteria will be included
Key inclusion criteria (3 listed)
- Age >18 years
- Signed informed consent
- Patients indicated for ERCP
Key exclusion criteria (6 listed)
- INR > 1.5
- Platelets < 50,000/mm³
- Patients with a prior endoscopic sphincterotomy
- Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
- Known pancreas divisum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difficult biliary cannulation
Time frame: 1 year
(> 5 minutes duration until cannulation, > 5 cannulation attempts, > 1 passage of the guidewire into the main pancreatic duct
4 secondary outcomes
Failure of biliary cannulation
Time frame: 1 year
Predictive factors for difficult cannulation and cannulation failure
Time frame: 1 year
Designing an "a priori" predictive model for difficult cannulation and cannulation failure
Time frame: 1 year
To carry out a cost study
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 16635233Baron TH, Petersen BT, Mergener K, Chak A, Cohen J, Deal SE, Hoffinan B, Jacobson BC, Petrini JL, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for endoscopic retrograde cholangiopancreatography. Am J Gastroenterol. 2006 Apr;101(4):892-7. doi: 10.1111/j.1572-0241.2006.00675.x. No abstract available.
- Results publication: PubMed 35442332Caceres-Escobar D, Munoz-Velandia OM, Vargas-Rubio R. FACTORS ASSOCIATED WITH DIFFICULT BILIARY CANNULATION IN A TRAINING CENTER FOR ENDOSCOPIC INTERVENTION OF THE BILIARY TRACT. Arq Gastroenterol. 2022 Jan-Mar;59(1):29-34. doi: 10.1590/S0004-2803.202200001-06.
- Results publication: PubMed 35025705Dalal A, Gandhi C, Patil G, Kamat N, Vora S, Maydeo A. Safety and efficacy of different techniques in difficult biliary cannulation at endoscopic retrograde cholangiopancreatography. Hosp Pract (1995). 2022 Feb;50(1):61-67. doi: 10.1080/21548331.2022.2029451. Epub 2022 Jan 20.
- Results publication: PubMed 34763384Saito H, Kadono Y, Shono T, Kamikawa K, Urata A, Nasu J, Imamura H, Matsushita I, Kakuma T, Tada S. Factors Predicting Difficult Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography for Common Bile Duct Stones. Clin Endosc. 2022 Mar;55(2):263-269. doi: 10.5946/ce.2021.153. Epub 2021 Nov 12.
- 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.
Antonio Z Gimeno García, MD, PhD principal investigator
University Hospital of the Canary Islands
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Biliary Cannulation, run by University of La Laguna.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Antonio Z Gimeno García, MD, PhD (34922678554, agimenog@ull.edu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficult biliary cannulation (time frame: 1 year). 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 NCT06591364, which also lists 4 linked publications.
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 19 Sep 2024.