Biliary DiseasesNCT01598142
Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique
A study testing Team 1 and Team 2 in people with Biliary Diseases and Pancreas Diseases, run by Qi-yong Li at 1 site in China.
Trial summary
The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Biliary Diseases, Pancreas Diseases
- What is being tested?
- Team 1 and Team 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 1 siteChina
- Study dates
- Oct 2007to Feb 2011
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP
Who cannot join
- previous endoscopic sphincterotomy,
- surgically altered anatomy (e.g. Billroth II gastrectomy) or
- diagnostic duodenoscopy
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study
The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.
Read the detailed description
A new single-operator wire-guided cannulation technique was performed on all patients. All procedures were performed by the same experienced endoscopist, but with different assistants in two groups (with an experienced one in Group A, and a new trained one in Group B). The number of attempts at cannulation, cannulation time, success rate, and procedure-related complications were compared between the two groups.
- Conditions
- Biliary Diseases, Pancreas Diseases
- Being tested
- Team 1, Team 2
- Keywords
- Endoscopic retrograde cholangiopancreatography (ERCP), Guidewires, Cannulation, Single-operator, C-Hook
- Medical subject headings
- Gallbladder Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team 1Procedure or surgery
Also called experienced
experienced endoscopist with a experienced assistant
Team 2Procedure or surgery
Also called new trained
same experienced endoscopist with a new trained assistant
| Study group | Role | What they receive |
|---|---|---|
| experienced assistant group | Other | experienced endoscopist with an experienced assistant. Receives: Procedure: Team 1 |
| new trained assistant group | Other | same experienced endoscopist with a new trained assistant Receives: Procedure: Team 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannulation success rate
Measured: two years
Secondary outcomes (6)
Incidences of post-ERCP pancreatitis
Measured: two years
Incidences of bleeding
Measured: two years
Incidences of perforation
Measured: two years
Incidences of infection
Measured: two years
Number of attempts at cannulation
Measured: two years
Cannulation time
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startOct 2007
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary DiseasesStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qi-yong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi-yong Li, Zhejiang University
- Investigators
- Qi-Yong Li, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598142
- Sponsor's protocol ID
- YLS2011-105
- Status last verified
- May 2012
- First submitted
- 1 Nov 2011
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01598142
- Acronym / sponsor ID
- YLS2011-105
- Conditions
- Biliary Diseases, Pancreas Diseases
- Keywords
- Endoscopic retrograde cholangiopancreatography (ERCP), Guidewires, Cannulation, Single-operator, C-Hook
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Qi-yong LiUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 May 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 single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.
Detailed description
A new single-operator wire-guided cannulation technique was performed on all patients. All procedures were performed by the same experienced endoscopist, but with different assistants in two groups (with an experienced one in Group A, and a new trained one in Group B). The number of attempts at cannulation, cannulation time, success rate, and procedure-related complications were compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experienced assistant group | Other | Procedure: Team 1experienced endoscopist with an experienced assistant. |
| new trained assistant group | Other | Procedure: Team 2same experienced endoscopist with a new trained assistant |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP
Key exclusion criteria (3 listed)
- previous endoscopic sphincterotomy,
- surgically altered anatomy (e.g. Billroth II gastrectomy) or
- diagnostic duodenoscopy
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 |
|---|---|---|
| Team 1Also: experiencedexperienced endoscopist with a experienced assistant | Procedure or surgery | experienced assistant group |
| Team 2Also: new trainedsame experienced endoscopist with a new trained assistant | Procedure or surgery | new trained assistant group |
Primary outcome
Cannulation success rate
Time frame: two years
6 secondary outcomes
Incidences of post-ERCP pancreatitis
Time frame: two years
Incidences of bleeding
Time frame: two years
Incidences of perforation
Time frame: two years
Incidences of infection
Time frame: two years
Number of attempts at cannulation
Time frame: two years
Cannulation time
Time frame: two years
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 15 May 2012.
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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.
Qi-Yong Li, MD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team 1 and Team 2 in people with Biliary Diseases and Pancreas Diseases, run by Qi-yong Li 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 1 inclusion and 3 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 15 May 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.
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?
Cannulation success rate (time frame: two years). 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 15 May 2012.