Biliary ObstructionNCT03118973
Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
A study testing Goff trans-pancreatic septotomy vs. Double wire technique in people with Biliary Obstruction and Biliary Stones, run by Subhas Banerjee at 1 site in United States.
Trial summary
Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic septotomy vs. double wire technique for achieving biliary access in patients who fail initial cannulation at ERCP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction, Biliary Stones
- What is being tested?
- Goff trans-pancreatic septotomy vs. Double wire technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2016to 1 Jan 2020
- 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
- Age 18 and older
- Patient has a clinical indication for ERCP
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Who cannot join
- Age <18
- Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
- Prior sphincterotomy or balloon dilation of ampulla
- Thrombocytopenia, coagulopathy, or indication for ongoing anti-coagulation therapy
- Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic septotomy vs. double wire technique for achieving biliary access in patients who fail initial cannulation at ERCP.
Read the detailed description
Selective placement of a guidewire into the bile duct (biliary cannulation) during endoscopic retrograde cholangiopancreatography (ERCP) is necessary for performing therapeutic biliary procedures. The success rate for biliary cannulation by experienced endoscopists during ERCP is approximately 85% with standard cannulation techniques. Inadvertent placement of the guidewire into the pancreatic duct rather than the bile duct often occurs when attempting selective biliary cannulation in technically challenging cases. When this occurs repeatedly, other approaches may be used to facilitate selective biliary cannulation, but there are few prospective studies evaluating the efficacy and safety of these approaches. Here the investigators evaluate two approaches for technically challenging biliary cannulation: one involving maintenance of a wire in the pancreatic duct, followed by repeat attempt at biliary cannulation (double wire technique) and one involving a small incision in the septum adjacent to the pancreas followed by repeat attempt at biliary cannulation (transpancreatic septotomy). This study is a prospective randomized trial comparing the rate of cannulation success, procedure duration and complications following these two approaches.
- Conditions
- Biliary Obstruction, Biliary Stones
- Being tested
- Goff trans-pancreatic septotomy vs. Double wire technique
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goff trans-pancreatic septotomy vs. Double wire techniqueProcedure or surgery
Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.
| Study group | Role | What they receive |
|---|---|---|
| Goff | Experimental | For patients in whom biliary cannulation is difficult to achieve, Goff trans-pancreatic septotomy will be performed to facilitate biliary cannulation. Receives: Procedure: Goff trans-pancreatic septotomy vs. Double wire technique |
| Double wire | Experimental | For patients in whom biliary cannulation is difficult to achieve, double wire technique will be used to facilitate biliary cannulation. Receives: Procedure: Goff trans-pancreatic septotomy vs. Double wire technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation
Successful biliary cannulation
Measured: Day of procedure
Secondary outcomes (1)
Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies
Rates of adverse events associated with the ERCP procedure following intervention to facilitate biliary cannulation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start27 Sep 2016
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies 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
- Patients with challenging biliary cannulation randomized to either Goff trans-pancreatic septotomy or double wire technique to facilitate biliary cannulation.
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Subhas Banerjee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Subhas Banerjee, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118973
- Sponsor's protocol ID
- 38574
- Status last verified
- Nov 2020
- First submitted
- 11 Apr 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
- ClinicalTrials.gov ID
- NCT03118973
- Acronym / sponsor ID
- 38574
- Conditions
- Biliary Obstruction, Biliary Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Subhas BanerjeeUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 18 Apr 2017 (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.
Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic septotomy vs. double wire technique for achieving biliary access in patients who fail initial cannulation at ERCP.
Detailed description
Selective placement of a guidewire into the bile duct (biliary cannulation) during endoscopic retrograde cholangiopancreatography (ERCP) is necessary for performing therapeutic biliary procedures. The success rate for biliary cannulation by experienced endoscopists during ERCP is approximately 85% with standard cannulation techniques. Inadvertent placement of the guidewire into the pancreatic duct rather than the bile duct often occurs when attempting selective biliary cannulation in technically challenging cases. When this occurs repeatedly, other approaches may be used to facilitate selective biliary cannulation, but there are few prospective studies evaluating the efficacy and safety of these approaches. Here the investigators evaluate two approaches for technically challenging biliary cannulation: one involving maintenance of a wire in the pancreatic duct, followed by repeat attempt at biliary cannulation (double wire technique) and one involving a small incision in the septum adjacent to the pancreas followed by repeat attempt at biliary cannulation (transpancreatic septotomy). This study is a prospective randomized trial comparing the rate of cannulation success, procedure duration and complications following these two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with challenging biliary cannulation randomized to either Goff trans-pancreatic septotomy or double wire technique to facilitate biliary cannulation.
| Arm | Type | Receives |
|---|---|---|
| Goff | Experimental | Procedure: Goff trans-pancreatic septotomy vs. Double wire techniqueFor patients in whom biliary cannulation is difficult to achieve, Goff trans-pancreatic septotomy will be performed to facilitate biliary cannulation. |
| Double wire | Experimental | Procedure: Goff trans-pancreatic septotomy vs. Double wire techniqueFor patients in whom biliary cannulation is difficult to achieve, double wire technique will be used to facilitate biliary cannulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- Patient has a clinical indication for ERCP
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Age <18
- Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
- Prior sphincterotomy or balloon dilation of ampulla
- Thrombocytopenia, coagulopathy, or indication for ongoing anti-coagulation therapy
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 |
|---|---|---|
| Goff trans-pancreatic septotomy vs. Double wire techniqueGoff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging. | Procedure or surgery | Double wire, Goff |
Primary outcome
Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation
Time frame: Day of procedure
Successful biliary cannulation
1 secondary outcome
Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies
Time frame: 6 months
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 13 Nov 2020.
- 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.
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 Goff trans-pancreatic septotomy vs. Double wire technique in people with Biliary Obstruction and Biliary Stones, run by Subhas Banerjee 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 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: finished, as of the sponsor's last update on 13 Nov 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 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?
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?
Successful biliary cannulation assessed by fluoroscopic confirmation of biliary 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?
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 13 Nov 2020.