Endoscopic Retrograde CholangiopancreatographyNCT04503200
Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.
A study testing Double guidewire and Transpancreatic precut in people with Endoscopic Retrograde Cholangiopancreatography and Common Bile Duct Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography, Common Bile Duct Diseases, Transpancreatic Precut
- What is being tested?
- Double guidewire and Transpancreatic precut
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2020to 30 Aug 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unintentional cannulation of the pancreatic duct 3 times
- Consenting to join the study
Who cannot join
- Previous ERCP with or without previous sphincterotomy
- Known coagulopathy
- - Pregnancy
- - Known acute pancreatitis at the time of procedure
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Cairo, 11562
Hany M Shehab, MD, 01111111071, H.shehab@kasralainy.edu.eg
Hany M Shehab, FRCP
About this study
Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Two valid options are available to facilitate cannulation at this point: Double guidewire technique or performing a transpancreatic precut. This is a randomized trial comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut after three unintentional passages of the guidewire into the pancreatic duct.
- Conditions
- Endoscopic Retrograde Cholangiopancreatography, Common Bile Duct Diseases, Transpancreatic Precut, Precut, Double Guidewire
- Being tested
- Double guidewire, Transpancreatic precut
- Medical subject headings
- Common Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double guidewireProcedure or surgery
After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.
Transpancreatic precutProcedure or surgery
After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.
| Study group | Role | What they receive |
|---|---|---|
| Double guidewire | Active comparator | Not described Receives: Procedure: Double guidewire |
| Transpancreatic precut | Active comparator | Not described Receives: Procedure: Transpancreatic precut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannulation success
Proportion of patients with successful cannulation of the common bile duct
Measured: Within 10 minutes
Rate of post-ERCP pancreatitis
Proportion of patients suffering post-ERCP pancreatitis
Measured: up to 24 hours after the procedure
Secondary outcomes (1)
Time to successful cannulation
Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct
Measured: Within 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start15 Aug 2020 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Shehab, Cairo University
- Investigators
- Hany M Shehab, Study chair, Kasr-Elaini Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503200
- Sponsor's protocol ID
- DGWRCT
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.
- ClinicalTrials.gov ID
- NCT04503200
- Acronym / sponsor ID
- DGWRCT
- Conditions
- Endoscopic Retrograde Cholangiopancreatography, Common Bile Duct Diseases, Transpancreatic Precut, Precut, Double Guidewire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 7 Aug 2020 (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.
Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Two valid options are available to facilitate cannulation at this point: Double guidewire technique or performing a transpancreatic precut. This is a randomized trial comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut after three unintentional passages of the guidewire into the pancreatic duct.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double guidewire | Active comparator | Procedure: Double guidewire |
| Transpancreatic precut | Active comparator | Procedure: Transpancreatic precut |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unintentional cannulation of the pancreatic duct 3 times
- Consenting to join the study
Key exclusion criteria (4 listed)
- Previous ERCP with or without previous sphincterotomy
- Known coagulopathy
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 |
|---|---|---|
| Double guidewireAfter the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct. | Procedure or surgery | Double guidewire |
| Transpancreatic precutAfter the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct. | Procedure or surgery | Transpancreatic precut |
Primary outcome
Cannulation success
Time frame: Within 10 minutes
Proportion of patients with successful cannulation of the common bile duct
Rate of post-ERCP pancreatitis
Time frame: up to 24 hours after the procedure
Proportion of patients suffering post-ERCP pancreatitis
1 secondary outcome
Time to successful cannulation
Time frame: Within 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
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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.
Hany M Shehab study chair
Kasr-Elaini Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double guidewire and Transpancreatic precut in people with Endoscopic Retrograde Cholangiopancreatography and Common Bile Duct Diseases, run by Cairo University at 1 site in Egypt.
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 4 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 7 Aug 2020. 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 Egypt. 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?
Contact Hany Shehab (01111111071, h.shehab@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannulation success (time frame: Within 10 minutes). The study lists 2 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 7 Aug 2020.