PancreatitisPhase 4NCT01744847
DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study
A Phase 4 study testing Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide in people with Pancreatitis and Cholangitis, run by Soon Chun Hyang University at 1 site in South Korea.
Trial summary
In patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatitis, Cholangitis, Cholecystitis
- What is being tested?
- Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2005to Aug 2012
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ERCP patient, over 20 years old, pancreatic duct cannulation patients by chance
Who cannot join
- refuse the ERCP, post procedure state(EST, subtotal gastrectomy, Whipples' Op except gastroduodenostomy), use another method, under 20 years old.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital
Seoul, Yongsan-gu, 140-743
About this study
Official title: DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Randomized Multi-center Study
In patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. The incidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.
Read the detailed description
This was a prospective, randomized study conducted in three tertiary referral hospital in Korea. Three endoscopists performed the ERCP who had ERCP experience more than ten years From October 2010 to August 2012, ERCPs were performed on patients with pancreatobiliary diseases at Soonchunhyang University Seoul Hospital, Hanyang University Guri Hospital and Kosin University Gospel Hospital. Bile duct cannulation was attempted for various reasons (removal of bile duct stones, biliary stenting, cytology of bile, biopsy of the bile duct, etc.).
Patients who satisfied the following inclusion criteria were enrolled in this study: (1) initially pancreatic duct cannulation by chance, (2) successful insertion of the guidewire into the pancreatic duct to at least half of the presumed total length of the pancreatic duct,, and (3) age 20 years or older. Exclusion criteria were: (1) refusal the ERCP, (2) previous endoscopic sphincterotomy or endoscopic papillary balloon dilatation, (3) acute pancreatitis at the time of the procedure, (4) pregnancy and (5) anatomical change due to past surgery; total gastrectomy, Billroth II operation, Whipples's operation etc. Patients who satisfied the inclusion criteria were randomly assigned to either the double-guidewire technique (DGT) group or the transpancreatic precut sphincterotomy (TPS) group; A randomization list for group allocation was generated by using computer-based pseudo-random number generators. We compared both techniques , for a maximum of ten extra attempts which are CBD cannulation by each methods. We obtained the written informed consent from all enrolled patients.
- Conditions
- Pancreatitis, Cholangitis, Cholecystitis
- Being tested
- Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
- Medical subject headings
- Pancreatitis, Cholangitis, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire GuideDevice
Also called Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation
| Study group | Role | What they receive |
|---|---|---|
| DGT, Tracer Metro® Direct™ Wire Guide | Active comparator | Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide Receives: Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide |
| TPS, Tracer Hybrid® Wire Guides | Active comparator | trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides Receives: Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate between DGT and TPS
from October 2010 to August 2012
Measured: up to 22months
Secondary outcomes (1)
median cannulation time between DGT and TPS
median time for precedure
Measured: during precedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startJan 2005
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Woong Cheul, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744847
- Sponsor's protocol ID
- MD-2012-010
- Status last verified
- Dec 2012
- First submitted
- 9 Nov 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Randomized Multi-center Study
- ClinicalTrials.gov ID
- NCT01744847
- Acronym / sponsor ID
- MD-2012-010
- Conditions
- Pancreatitis, Cholangitis, Cholecystitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 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.
In patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. The incidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.
Detailed description
This was a prospective, randomized study conducted in three tertiary referral hospital in Korea. Three endoscopists performed the ERCP who had ERCP experience more than ten years From October 2010 to August 2012, ERCPs were performed on patients with pancreatobiliary diseases at Soonchunhyang University Seoul Hospital, Hanyang University Guri Hospital and Kosin University Gospel Hospital. Bile duct cannulation was attempted for various reasons (removal of bile duct stones, biliary stenting, cytology of bile, biopsy of the bile duct, etc.).
Patients who satisfied the following inclusion criteria were enrolled in this study: (1) initially pancreatic duct cannulation by chance, (2) successful insertion of the guidewire into the pancreatic duct to at least half of the presumed total length of the pancreatic duct,, and (3) age 20 years or older. Exclusion criteria were: (1) refusal the ERCP, (2) previous endoscopic sphincterotomy or endoscopic papillary balloon dilatation, (3) acute pancreatitis at the time of the procedure, (4) pregnancy and (5) anatomical change due to past surgery; total gastrectomy, Billroth II operation, Whipples's operation etc. Patients who satisfied the inclusion criteria were randomly assigned to either the double-guidewire technique (DGT) group or the transpancreatic precut sphincterotomy (TPS) group; A randomization list for group allocation was generated by using computer-based pseudo-random number generators. We compared both techniques , for a maximum of ten extra attempts which are CBD cannulation by each methods. We obtained the written informed consent from all enrolled patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DGT, Tracer Metro® Direct™ Wire Guide | Active comparator | Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire GuideDouble guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide |
| TPS, Tracer Hybrid® Wire Guides | Active comparator | Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guidetrans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ERCP patient, over 20 years old, pancreatic duct cannulation patients by chance
Key exclusion criteria (1 listed)
- refuse the ERCP, post procedure state(EST, subtotal gastrectomy, Whipples' Op except gastroduodenostomy), use another method, under 20 years old.
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 |
|---|---|---|
| Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire GuideAlso: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guideone guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation | Device | DGT, Tracer Metro® Direct™ Wire Guide, TPS, Tracer Hybrid® Wire Guides |
Primary outcome
success rate between DGT and TPS
Time frame: up to 22months
from October 2010 to August 2012
1 secondary outcome
median cannulation time between DGT and TPS
Time frame: during precedure time
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 7 Dec 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.
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 Phase 4 study testing Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide in people with Pancreatitis and Cholangitis, run by Soon Chun Hyang University at 1 site in South Korea.
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 1 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 7 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
success rate between DGT and TPS (time frame: up to 22months). 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 Dec 2012.