ERCP, Difficult CBD CannulationNCT06315647
Comparison Between Different Techniques in Difficult CBD Cannulation
A study testing DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation in people with ERCP, Difficult CBD Cannulation, run by Menoufia University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERCP, Difficult CBD Cannulation
- What is being tested?
- DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 20 Nov 2023
- 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
- Patients having different biliary tract disorders for which ERCP is indicated and after which they defined as having difficult CBD cannulation.
Who cannot join
- Age of less than18 years.
- Coagulopathy in terms of INR>2.
- Patients with severe heart disease defined as patients with decompensated heart diseases or EF > 40%.
- Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
- Complicated acute pancreatitis defined as patients with moderate to sever acute pancreatitis according to Revised ATLANTA criteria 2012.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Double Guide Wire Technique Versus Trans Pancreatic Sphincterotomy Versus Precut and Fistulotomy Techniques for Difficult Biliary Cannulation
This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation.
Read the detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) is the standard procedure for diagnostic and therapeutic interventions for pancreatobiliary diseases. Bile duct cannulation is the most basic and important technique for carrying out diagnostic and therapeutic biliary interventions.
Since the advent of ERCP selective cannulation of the biliary duct is the most important step for successful treatment of biliary tract diseases during ERCP procedures, despite various accessory devices, the standard biliary cannulation technique has been reported to fail in approximately 5-20% cases.
Various endoscopic techniques for Selective Bile duct cannulation have been reported, including standard techniques (e.g. contrast injection technique, wire-guided cannulation ), pancreatic guidewire technique (e.g. double guidewire technique [DGW]), precut sphincterotomy, endoscopic papillectomy, endoscopic ultrasound-guided rendezvous procedure, and percutaneous transhepatic biliary drainage-guided procedure.
Bile duct cannulation can be difficult because of; different anatomical features, inflammatory processes, and adenomas of the papilla or periampullary diverticulum. Large prospective studies have demonstrated that difficult cannulation is an independent risk factor for post ERCP pancreatitis.
As the technique developed, several supplementary techniques have been recommended to facilitate the access to the common bile duct in cases of standard biliary cannulation failure, these are known to significantly increase not only the success rate of selective biliary cannulation but also the complication rate .
Commonly, a precutting technique is used to allow biliary access when the standard cannulation technique failed. There are types of precutting technique: needle-knife papillotomy, suprapapillary fistulotomy and trans pancreatic sphincterotomy, in terms of effectiveness and efficiency of the precutting technique, TPS, which does not need avoiding pancreatic duct cannulation unintentionally, is an effective method especially for difficult biliary cannulation.
Also, the use of a guidewire to physically occupy the pancreatic duct, also known as the double guidewire technique, this method has been used with promising results in cases of complex biliary cannulation, especially in patients with a distorted BD anatomy caused by neoplasia or atypical morphology of the ampulla.
- Conditions
- ERCP, Difficult CBD Cannulation
- Being tested
- DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulationProcedure or surgery
comparison between different technique in difficult CBD cannulation
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled for double guide wire technique. | Active comparator | Not described Receives: Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation |
| Patients enrolled for trans - pancreatic sphincterotomy technique. | Active comparator | Not described Receives: Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation |
| Patients enrolled for needle knife precut technique or fistulotomy technique. | Active comparator | Not described Receives: Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography
compare efficacy of different cannulation techniques for difficult CBD cannulation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Dec 2019
- Primary completion19 Jan 2023
- Study completion20 Nov 2023
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 ERCP, Difficult CBD 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El Said Salam, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315647
- Sponsor's protocol ID
- Difficult CBD cannulation
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miao L, Li QP, Zhu MH, Ge XX, Yu H, Wang F, Ji GZ. Endoscopic transpancreatic septotomy as a precutting technique for difficult bile duct cannulation. World J Gastroenterol. 2015 Apr 7;21(13):3978-82. doi: 10.3748/wjg.v21.i13.3978.
PubMed 25852284Yoo YW, Cha SW, Lee WC, Kim SH, Kim A, Cho YD. Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation. World J Gastroenterol. 2013 Jan 7;19(1):108-14. doi: 10.3748/wjg.v19.i1.108.
PubMed 23326171Huang L, Yu QS, Zhang Q, Liu JD, Wang Z. Comparison between double-guidewire technique and transpancreatic sphincterotomy technique for difficult biliary cannulation. Dig Endosc. 2015 Mar;27(3):381-7. doi: 10.1111/den.12387. Epub 2014 Nov 11.
PubMed 25284147Elhoseeny MM, Alhaddad O, Elsabaawy M, Abdelsameea E, Sallam A, Khamis A, Edrees A, Othman AAA. Advanced and salvage techniques for difficult biliary cannulation in endoscopic retrograde cholangiopancreatography: a randomized trial of outcomes and efficacy. Gastrointest Endosc. 2026 Jul 15:S0016-5107(26)06885-9. doi: 10.1016/j.gie.2026.07.004. Online ahead of print.
PubMed 42456983
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Double Guide Wire Technique Versus Trans Pancreatic Sphincterotomy Versus Precut and Fistulotomy Techniques for Difficult Biliary Cannulation
- ClinicalTrials.gov ID
- NCT06315647
- Acronym / sponsor ID
- Difficult CBD cannulation
- Conditions
- ERCP, Difficult CBD Cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 18 Mar 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.
This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation.
Detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) is the standard procedure for diagnostic and therapeutic interventions for pancreatobiliary diseases. Bile duct cannulation is the most basic and important technique for carrying out diagnostic and therapeutic biliary interventions.
Since the advent of ERCP selective cannulation of the biliary duct is the most important step for successful treatment of biliary tract diseases during ERCP procedures, despite various accessory devices, the standard biliary cannulation technique has been reported to fail in approximately 5-20% cases.
Various endoscopic techniques for Selective Bile duct cannulation have been reported, including standard techniques (e.g. contrast injection technique, wire-guided cannulation ), pancreatic guidewire technique (e.g. double guidewire technique [DGW]), precut sphincterotomy, endoscopic papillectomy, endoscopic ultrasound-guided rendezvous procedure, and percutaneous transhepatic biliary drainage-guided procedure.
Bile duct cannulation can be difficult because of; different anatomical features, inflammatory processes, and adenomas of the papilla or periampullary diverticulum. Large prospective studies have demonstrated that difficult cannulation is an independent risk factor for post ERCP pancreatitis.
As the technique developed, several supplementary techniques have been recommended to facilitate the access to the common bile duct in cases of standard biliary cannulation failure, these are known to significantly increase not only the success rate of selective biliary cannulation but also the complication rate .
Commonly, a precutting technique is used to allow biliary access when the standard cannulation technique failed. There are types of precutting technique: needle-knife papillotomy, suprapapillary fistulotomy and trans pancreatic sphincterotomy, in terms of effectiveness and efficiency of the precutting technique, TPS, which does not need avoiding pancreatic duct cannulation unintentionally, is an effective method especially for difficult biliary cannulation.
Also, the use of a guidewire to physically occupy the pancreatic duct, also known as the double guidewire technique, this method has been used with promising results in cases of complex biliary cannulation, especially in patients with a distorted BD anatomy caused by neoplasia or atypical morphology of the ampulla.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled for double guide wire technique. | Active comparator | Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation |
| Patients enrolled for trans - pancreatic sphincterotomy technique. | Active comparator | Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation |
| Patients enrolled for needle knife precut technique or fistulotomy technique. | Active comparator | Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having different biliary tract disorders for which ERCP is indicated and after which they defined as having difficult CBD cannulation.
Key exclusion criteria (6 listed)
- Age of less than18 years.
- Coagulopathy in terms of INR>2.
- Patients with severe heart disease defined as patients with decompensated heart diseases or EF > 40%.
- Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
- Complicated acute pancreatitis defined as patients with moderate to sever acute pancreatitis according to Revised ATLANTA criteria 2012.
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 |
|---|---|---|
| DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulationcomparison between different technique in difficult CBD cannulation | Procedure or surgery | Patients enrolled for double guide wire technique., Patients enrolled for needle knife precut technique or fistulotomy technique., Patients enrolled for trans - pancreatic sphincterotomy technique. |
Primary outcome
Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography
Time frame: Baseline
compare efficacy of different cannulation techniques for difficult CBD cannulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 25852284Miao L, Li QP, Zhu MH, Ge XX, Yu H, Wang F, Ji GZ. Endoscopic transpancreatic septotomy as a precutting technique for difficult bile duct cannulation. World J Gastroenterol. 2015 Apr 7;21(13):3978-82. doi: 10.3748/wjg.v21.i13.3978.
- Background: PubMed 23326171Yoo YW, Cha SW, Lee WC, Kim SH, Kim A, Cho YD. Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation. World J Gastroenterol. 2013 Jan 7;19(1):108-14. doi: 10.3748/wjg.v19.i1.108.
- Background: PubMed 25284147Huang L, Yu QS, Zhang Q, Liu JD, Wang Z. Comparison between double-guidewire technique and transpancreatic sphincterotomy technique for difficult biliary cannulation. Dig Endosc. 2015 Mar;27(3):381-7. doi: 10.1111/den.12387. Epub 2014 Nov 11.
- Derived from this study: PubMed 42456983Elhoseeny MM, Alhaddad O, Elsabaawy M, Abdelsameea E, Sallam A, Khamis A, Edrees A, Othman AAA. Advanced and salvage techniques for difficult biliary cannulation in endoscopic retrograde cholangiopancreatography: a randomized trial of outcomes and efficacy. Gastrointest Endosc. 2026 Jul 15:S0016-5107(26)06885-9. doi: 10.1016/j.gie.2026.07.004. Online ahead of print.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation in people with ERCP, Difficult CBD Cannulation, run by Menoufia 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 1 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: finished, as of the sponsor's last update on 18 Mar 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography (time frame: Baseline). 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 NCT06315647, 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 18 Mar 2024.