Endoscopic Retrograde CholangiopancreatographyPhase 3NCT01745978
Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation
A Phase 3 study testing Precut papillotomy in people with Endoscopic Retrograde Cholangiopancreatography and Bile Duct Diseases, run by Changhai Hospital at 1 site in China.
Trial summary
The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography, Bile Duct Diseases
- What is being tested?
- Precut papillotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intact papilla and deep cannulation of the bile duct
- a standard wire-guided cannulation >10 minutes, OR Pancreatic contrast injections ≥3, OR Pancreatic deep wire pass ≥5
Who cannot join
- ampullary tumors
- Billroth II or Roux-en-Y anatomy
- prior endoscopic sphincterotomy(EST) or biliary stent
- choledochoduodenal fistulae
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, 200433
zhaoshen Li, MD, 86-21-81873241, zhaoshenlismmu@gmail.com
zhaoshen Li, MD
About this study
Official title: The Efficacy and Safety of Precut Papillotomy Using the Knob-tipped Knife and Needle Knife in Difficult Biliary Cannulation: a Randomized-controlled Trial.
The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.
Read the detailed description
Precut sphincterotomy is an alternative technique used to facilitate CBD cannulation following the failure of conventional bile duct cannulation. Needle knife papillotomy is the most widely practiced precut technique. However,Pre-cutting the papilla with a needle-knife is difficult, requiring experience and dexterity to control the axis and depth of the cut. Due to the increased rate of complications associated with this procedure, including pancreatitis, hemorrhage, and perforation, it was recommended to be performed only by experienced endoscopists.
The knob-tipped knife, a novel instrument utilizing a 2mm or 1.5mm cutting knife, is usually used for endoscopic submucosal dissection (ESD). Its knob-shaped tip and nonadjustable length make the knife less likely to slip and penetrate the tissue during the resection. Since the process of precut papillotomy is similar to ESD, the precutting procedure with the knob-tipped knife may be easier to be performed, as well as be safer. The efficacy and safety of this instrument in precut papillotomy have not been reported. We therefore assessed the efficacy and safety of the knob-tipped knife in precut papillotomy in difficult CBD cannulation.
- Being tested
- Precut papillotomy
- Medical subject headings
- Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precut papillotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| the knob-tipped knife | Experimental | the knob-tipped knife using for precut papillotomy in difficult CBD cannulation Receives: Procedure: Precut papillotomy |
| the needle knife | Active comparator | the needle knife using for precut papillotomy in difficult CBD cannulation Receives: Procedure: Precut papillotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful biliary cannulation rate after precut papillotomy
Measured: During endoscopic retrograde cholangiopancreatography (ERCP) procedure
Secondary outcomes (1)
Biliary cannulation time after precut papillotomy
Measured: From precut papillotomy started to biliary cannulation achieved or abandoned
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (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 Changhai HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745978
- Sponsor's protocol ID
- changhai-121202
- Status last verified
- Dec 2012
- First submitted
- 6 Dec 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Precut Papillotomy Using the Knob-tipped Knife and Needle Knife in Difficult Biliary Cannulation: a Randomized-controlled Trial.
- ClinicalTrials.gov ID
- NCT01745978
- Acronym / sponsor ID
- changhai-121202
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Dec 2012 (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.
The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.
Detailed description
Precut sphincterotomy is an alternative technique used to facilitate CBD cannulation following the failure of conventional bile duct cannulation. Needle knife papillotomy is the most widely practiced precut technique. However,Pre-cutting the papilla with a needle-knife is difficult, requiring experience and dexterity to control the axis and depth of the cut. Due to the increased rate of complications associated with this procedure, including pancreatitis, hemorrhage, and perforation, it was recommended to be performed only by experienced endoscopists.
The knob-tipped knife, a novel instrument utilizing a 2mm or 1.5mm cutting knife, is usually used for endoscopic submucosal dissection (ESD). Its knob-shaped tip and nonadjustable length make the knife less likely to slip and penetrate the tissue during the resection. Since the process of precut papillotomy is similar to ESD, the precutting procedure with the knob-tipped knife may be easier to be performed, as well as be safer. The efficacy and safety of this instrument in precut papillotomy have not been reported. We therefore assessed the efficacy and safety of the knob-tipped knife in precut papillotomy in difficult CBD cannulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the knob-tipped knife | Experimental | Procedure: Precut papillotomythe knob-tipped knife using for precut papillotomy in difficult CBD cannulation |
| the needle knife | Active comparator | Procedure: Precut papillotomythe needle knife using for precut papillotomy in difficult CBD cannulation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- intact papilla and deep cannulation of the bile duct
- a standard wire-guided cannulation >10 minutes, OR Pancreatic contrast injections ≥3, OR Pancreatic deep wire pass ≥5
Key exclusion criteria (4 listed)
- ampullary tumors
- Billroth II or Roux-en-Y anatomy
- prior endoscopic sphincterotomy(EST) or biliary stent
- choledochoduodenal fistulae
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 |
|---|---|---|
| Precut papillotomy | Procedure or surgery | the knob-tipped knife, the needle knife |
Primary outcome
Successful biliary cannulation rate after precut papillotomy
Time frame: During endoscopic retrograde cholangiopancreatography (ERCP) procedure
1 secondary outcome
Biliary cannulation time after precut papillotomy
Time frame: From precut papillotomy started to biliary cannulation achieved or abandoned
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
Related trials for Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
Not yet recruiting
XRAIconnect Image Guidance Software for ERCP Procedures
Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
Recruiting
Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
Anesthesia, Sedation
Not yet recruiting
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
Pancreatitis
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 Phase 3 study testing Precut papillotomy in people with Endoscopic Retrograde Cholangiopancreatography and Bile Duct Diseases, run by Changhai Hospital at 1 site in China.
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 10 Dec 2012. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 zhaoshen Li, MD (86-21-81873241, zhaoshenlismmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful biliary cannulation rate after precut papillotomy (time frame: During endoscopic retrograde cholangiopancreatography (ERCP) 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 10 Dec 2012.